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Trial record 1 of 1 for:    A3921137
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A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01519089
Recruitment Status : Completed
First Posted : January 26, 2012
Results First Posted : August 13, 2015
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: CP-690,550
Drug: CP-690, 550
Enrollment 95
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID
Hide Arm/Group Description CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52. CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
Period Title: Overall Study
Started 47 48
Received Treatment 47 47
Completed 40 33
Not Completed 7 15
Reason Not Completed
Adverse Event             4             4
Lack of Efficacy             0             2
Lost to Follow-up             1             0
Withdrawal by Subject             0             2
Other             2             6
Not received study drug             0             1
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52. CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52. Total of all reporting groups
Overall Number of Baseline Participants 47 47 94
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 47 participants 94 participants
50.9  (11.8) 46.4  (10.8) 48.7  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 participants
Female
8
  17.0%
8
  17.0%
16
  17.0%
Male
39
  83.0%
39
  83.0%
78
  83.0%
1.Primary Outcome
Title Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16
Hide Description The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Measure Type: Number
Unit of Measure: Percentage of participants
62.8 72.7 67.8
2.Primary Outcome
Title Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16
Hide Description The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Measure Type: Number
Unit of Measure: Percentage of participants
67.4 68.2 67.8
3.Primary Outcome
Title Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16
Hide Description ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 4 8 12
Measure Type: Number
Unit of Measure: Percentage of participants
100 100 100
4.Primary Outcome
Title Number of Participants With Adjudicated Cardiovacular Events
Hide Description Adjudicated cardiovascular events were assessed by investigators as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; specific requirements vary with the event requiring adjudication.
Time Frame Baseline to Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 47 47 94
Measure Type: Number
Unit of Measure: Participants
0 0 0
5.Primary Outcome
Title Number of Participants With Malignancy Events _Week 0 Through Follow-up
Hide Description For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist's report to the central laboratory for a blinded review by a central pathologist.
Time Frame Baseline to Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Participants treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 47 47 94
Measure Type: Number
Unit of Measure: Participants
Number of participants with any malignancy events 0 0 0
Malignancy excluding non-melanoma skin cancer 0 0 0
Lymphoma/Lymphoproliferative disorders (LPD) 0 0 0
Melanoma 0 0 0
Non-melanoma skin cancer 0 0 0
6.Secondary Outcome
Title Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
Hide Description The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at the each visit relative to Baseline.
Time Frame Week 2, 4, 8, 12, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 2.3 4.5 3.4
Week 4 7.0 22.7 14.9
Week 8 41.9 54.5 48.3
Week 12 60.5 70.5 65.5
Week 20 67.4 63.6 65.5
Week 28 69.8 65.9 67.8
Week 40 69.8 63.6 66.7
Week 52 62.8 63.6 63.2
7.Secondary Outcome
Title Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
Hide Description The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least a 50 percent (%) reduction in PASI at the each visit relative to Baseline.
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 9.3 22.7 16.1
Week 4 34.9 56.8 46.0
Week 8 60.5 81.8 71.3
Week 12 81.4 84.1 82.8
Week 16 76.7 79.5 78.2
Week 20 79.1 75.0 77.0
Week 28 90.7 72.7 81.6
Week 40 88.4 79.5 83.9
Week 52 90.7 68.2 79.3
8.Secondary Outcome
Title Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
Hide Description The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90 percent (%) reduction in PASI at the each visit relative to Baseline.
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 0.0 0.0 0.0
Week 4 4.7 13.6 9.2
Week 8 16.3 29.5 23.0
Week 12 37.2 45.5 41.4
Week 16 37.2 54.5 46.0
Week 20 58.1 56.8 57.5
Week 28 55.8 45.5 50.6
Week 40 58.1 47.7 52.9
Week 52 51.2 47.7 49.4
9.Secondary Outcome
Title Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Hide Description The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Median (95% Confidence Interval)
Unit of Measure: Week
8.0
(8.0 to 12.0)
8.0
(4.0 to 12.0)
8.0 [1] 
(NA to NA)
[1]
The 95 percent confidence interval could not be constructed.
10.Secondary Outcome
Title Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response
Hide Description The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Median (95% Confidence Interval)
Unit of Measure: Week
12.0
(8.0 to 16.0)
8.0
(8.0 to 12.0)
12.0
(8.0 to 12.0)
11.Secondary Outcome
Title Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response
Hide Description The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Median (95% Confidence Interval)
Unit of Measure: Week
8.0
(4.0 to 12.0)
4.0
(4.0 to 8.0)
8.0
(4.0 to 8.0)
12.Secondary Outcome
Title Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response
Hide Description The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least 90% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Median (95% Confidence Interval)
Unit of Measure: Week
NA [1] 
(12.0 to NA)
12.0
(12.0 to 16.0)
16.0 [2] 
(12.0 to NA)
[1]
The median time could not be computed because fewer than half of the subjects achieved a PASI90 response.
[2]
The 95 percent upper limit could not be computed due to the limited analysis duration up to Week 16.
13.Secondary Outcome
Title Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
Hide Description The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 2.3 0.0 1.1
Week 4 0.0 2.3 1.1
Week 8 (n=43, 41, 84) 0.0 0.0 0.0
Week 12 (n=43, 41, 84) 0.0 2.4 1.2
Week 16 (n=43, 40, 83) 0.0 2.5 1.2
Week 20 (n=43, 39, 82) 0.0 0.0 0.0
Week 28 (n=43, 39, 82) 0.0 0.0 0.0
Week 40 (n=41, 38, 79) 0.0 0.0 0.0
Week 52 (n=39, 32, 71) 0.0 0.0 0.0
14.Secondary Outcome
Title Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Hide Description The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 2 -5.18  (5.898) -7.36  (6.428) -6.28  (6.232)
Week 4 -10.40  (7.518) -13.16  (8.739) -11.79  (8.229)
Week 8 (n=43, 41, 84) -15.95  (8.392) -19.90  (10.741) -17.88  (9.756)
Week 12 (n=43, 41, 84) -18.91  (8.918) -21.68  (11.598) -20.26  (10.344)
Week 16 (n=43, 40, 83) -19.53  (9.094) -22.06  (12.606) -20.75  (10.935)
Week 20 (n=43, 39, 82) -20.95  (9.239) -22.18  (12.045) -21.53  (10.617)
Week 28 (n=43, 39, 82) -21.77  (10.196) -21.46  (10.503) -21.62  (10.280)
Week 40 (n=41, 38, 79) -22.20  (10.181) -21.18  (10.229) -21.71  (10.151)
Week 52 (n=39, 32, 71) -21.96  (9.621) -22.11  (10.598) -22.03  (10.000)
15.Secondary Outcome
Title Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Hide Description The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 2: Erythema (Head/Neck) -0.5  (0.83) -0.9  (0.82) -0.7  (0.84)
Week 2: Erythema (Upper Limbs) -0.5  (0.67) -0.8  (0.72) -0.6  (0.70)
Week 2: Erythema (Trunk) -0.6  (0.67) -0.8  (0.69) -0.7  (0.69)
Week 2: Erythema (Lower Limbs) -0.7  (0.69) -0.8  (0.71) -0.7  (0.70)
Week 2: Induration (Head/Neck) -0.4  (0.70) -0.8  (0.89) -0.6  (0.82)
Week 2: Induration (Upper Limbs) -0.5  (0.63) -0.6  (0.75) -0.6  (0.69)
Week 2: Induration (Trunk) -0.5  (0.63) -0.7  (0.59) -0.6  (0.62)
Week 2: Induration (Lower Limbs) -0.5  (0.67) -0.7  (0.71) -0.6  (0.69)
Week 2: Scaling (Head/Neck) -0.4  (0.66) -0.9  (0.91) -0.7  (0.83)
Week 2: Scaling (Upper Limbs) -0.4  (0.59) -0.8  (0.74) -0.6  (0.69)
Week 2: Scaling (Trunk) -0.3  (0.57) -0.8  (0.76) -0.6  (0.71)
Week 2: Scaling (Lower Limbs) -0.4  (0.70) -0.7  (0.73) -0.6  (0.73)
Week 4: Erythema (Head/Neck) -0.8  (1.02) -1.3  (0.99) -1.0  (1.02)
Week 4: Erythema (Upper Limbs) -1.1  (0.81) -1.2  (0.94) -1.1  (0.87)
Week 4: Erythema (Trunk) -1.0  (0.64) -1.3  (0.79) -1.1  (0.72)
Week 4: Erythema (Lower Limbs) -1.1  (0.91) -1.2  (0.79) -1.2  (0.85)
Week 4: Induration (Head/Neck) -0.7  (0.89) -1.2  (1.09) -1.0  (1.02)
Week 4: Induration (Upper Limbs) -1.1  (0.86) -1.0  (0.85) -1.0  (0.85)
Week 4: Induration (Trunk) -0.9  (0.80) -1.3  (0.82) -1.1  (0.83)
Week 4: Induration (Lower Limbs) -1.0  (0.90) -1.2  (0.98) -1.1  (0.94)
Week 4: Scaling (Head/Neck) -0.8  (0.86) -1.2  (0.99) -1.0  (0.95)
Week 4: Scaling (Upper Limbs) -0.9  (0.70) -1.2  (0.86) -1.0  (0.79)
Week 4: Scaling (Trunk) -0.9  (0.71) -1.3  (0.95) -1.1  (0.87)
Week 4: Scaling (Lower Limbs) -0.8  (0.72) -1.3  (0.96) -1.1  (0.89)
Week 8: Erythema (Head/Neck) (n=43, 41, 84) -1.4  (1.13) -1.6  (1.03) -1.5  (1.08)
Week 8: Erythema (Upper Limbs) (n=43, 41, 84) -1.5  (0.93) -1.6  (0.98) -1.5  (0.95)
Week 8: Erythema (Trunk) (n=43, 41, 84) -1.7  (0.91) -1.9  (0.93) -1.8  (0.92)
Week 8: Erythema (Lower Limbs) (n=43, 41, 84) -1.5  (0.91) -1.7  (0.91) -1.6  (0.91)
Week 8: Induration (Head/Neck) (n=43, 41, 84) -1.3  (0.91) -1.6  (1.10) -1.4  (1.01)
Week 8: Induration (Upper Limbs) (n=43, 41, 84) -1.6  (0.93) -1.6  (0.89) -1.6  (0.91)
Week 8: Induration (Trunk) (n=43, 41, 84) -1.6  (0.98) -1.7  (1.03) -1.7  (1.00)
Week 8: Induration (Lower Limbs) (n=43, 41, 84) -1.6  (0.91) -1.7  (0.98) -1.7  (0.94)
Week 8: Scaling (Head/Neck) (n=43, 41, 84) -1.3  (0.90) -1.5  (1.03) -1.4  (0.96)
Week 8: Scaling (Upper Limbs) (n=43, 41, 84) -1.3  (0.80) -1.6  (0.86) -1.5  (0.84)
Week 8: Scaling (Trunk) (n=43, 41, 84) -1.4  (0.82) -1.8  (1.00) -1.6  (0.93)
Week 8: Scaling (Lower Limbs) (n=43, 41, 84) -1.3  (0.82) -1.8  (0.88) -1.5  (0.88)
Week 12: Erythema (Head/Neck) (n=43, 41, 84) -1.7  (1.10) -1.7  (0.98) -1.7  (1.04)
Week 12: Erythema (Upper Limbs) (n=43, 41, 84) -1.9  (0.99) -1.8  (1.13) -1.8  (1.05)
Week 12: Erythema (Trunk) (n=43, 41, 84) -2.1  (1.08) -2.0  (0.95) -2.0  (1.01)
Week 12: Erythema (Lower Limbs) (n=43, 41, 84) -1.9  (0.92) -1.9  (0.94) -1.9  (0.92)
Week 12: Induration (Head/Neck) (n=43, 41, 84) -1.5  (0.94) -1.6  (1.12) -1.6  (1.02)
Week 12: Induration (Upper Limbs) (n=43, 41, 84) -1.7  (0.94) -1.8  (0.99) -1.7  (0.96)
Week 12: Induration (Trunk) (n=43, 41, 84) -2.0  (1.01) -2.0  (1.00) -2.0  (1.00)
Week 12: Induration (Lower Limbs) (n=43, 41, 84) -1.9  (0.91) -1.9  (1.06) -1.9  (0.98)
Week 12: Scaling (Head/Neck) (n=43, 41, 84) -1.7  (0.92) -1.6  (1.02) -1.6  (0.96)
Week 12: Scaling (Upper Limbs) (n=43, 41, 84) -1.4  (0.91) -1.7  (0.95) -1.6  (0.94)
Week 12: Scaling (Trunk) (n=43, 41, 84) -1.6  (1.05) -1.9  (1.00) -1.7  (1.03)
Week 12: Scaling (Lower Limbs) (n=43, 41, 84) -1.5  (0.85) -1.9  (1.00) -1.7  (0.95)
Week 16: Erythema (Head/Neck) (n=43, 40, 83) -1.7  (1.14) -1.7  (1.07) -1.7  (1.10)
Week 16: Erythema (Upper Limbs) (n=43, 40, 83) -1.9  (1.13) -1.9  (1.12) -1.9  (1.12)
Week 16: Erythema (Trunk) (n=43, 40, 83) -2.1  (1.10) -2.0  (1.07) -2.0  (1.08)
Week 16: Erythema (Lower Limbs) (n=43, 40, 83) -2.0  (1.03) -1.9  (0.94) -2.0  (0.99)
Week 16: Induration (Head/Neck) (n=43, 40, 83) -1.5  (0.96) -1.6  (1.17) -1.6  (1.06)
Week 16: Induration (Upper Limbs) (n=43, 40, 83) -1.8  (0.96) -1.8  (1.01) -1.8  (0.98)
Week 16: Induration (Trunk) (n=43, 40, 83) -2.1  (1.01) -2.0  (1.01) -2.0  (1.01)
Week 16: Induration (Lower Limbs) (n=43, 40, 83) -2.1  (0.95) -2.0  (1.08) -2.0  (1.01)
Week 16: Scaling (Head/Neck) (n=43, 40, 83) -1.6  (0.95) -1.6  (1.08) -1.6  (1.01)
Week 16: Scaling (Upper Limbs) (n=43, 40, 83) -1.5  (0.93) -1.7  (1.05) -1.6  (0.99)
Week 16: Scaling (Trunk) (n=43, 40, 83) -1.6  (0.96) -1.8  (1.09) -1.7  (1.02)
Week 16: Scaling (Lower Limbs) (n=43, 40, 83) -1.6  (0.93) -1.8  (1.06) -1.7  (1.00)
Week 20: Erythema (Head/Neck) (n=43, 39, 82) -1.8  (1.15) -1.6  (0.96) -1.7  (1.07)
Week 20: Erythema (Upper Limbs) (n=43, 39, 82) -1.9  (0.97) -1.9  (1.26) -1.9  (1.11)
Week 20: Erythema (Trunk) (n=43, 39, 82) -2.2  (1.04) -2.1  (1.04) -2.1  (1.04)
Week 20: Erythema (Lower Limbs) (n=43, 39, 82) -2.1  (1.04) -2.1  (1.09) -2.1  (1.05)
Week 20: Induration (Head/Neck) (n=43, 39, 82) -1.6  (1.00) -1.5  (1.12) -1.6  (1.06)
Week 20: Induration (Upper Limbs) (n=43, 39, 82) -1.9  (0.97) -1.7  (1.14) -1.8  (1.05)
Week 20: Induration (Trunk) (n=43, 39, 82) -2.1  (1.01) -1.9  (1.07) -2.0  (1.04)
Week 20: Induration (Lower Limbs) (n=43, 39, 82) -2.2  (0.95) -2.0  (1.06) -2.1  (1.00)
Week 20: Scaling (Head/Neck) (n=43, 39, 82) -1.7  (0.94) -1.5  (1.05) -1.6  (0.99)
Week 20: Scaling (Upper Limbs) (n=43, 39, 82) -1.5  (0.96) -1.6  (1.14) -1.5  (1.04)
Week 20: Scaling (Trunk) (n=43, 39, 82) -1.7  (0.93) -1.8  (1.05) -1.8  (0.99)
Week 20: Scaling (Lower Limbs) (n=43, 39, 82) -1.7  (0.92) -1.8  (1.16) -1.8  (1.04)
Week 28: Erythema (Head/Neck) (n=43, 39, 82) -1.8  (1.11) -1.6  (0.81) -1.7  (0.98)
Week 28: Erythema (Upper Limbs) (n=43, 39, 82) -2.1  (1.09) -1.8  (1.07) -2.0  (1.08)
Week 28: Erythema (Trunk) (n=43, 39, 82) -2.1  (1.13) -2.0  (0.99) -2.1  (1.06)
Week 28: Erythema (Lower Limbs) (n=43, 39, 82) -2.3  (1.05) -1.9  (0.99) -2.1  (1.03)
Week 28: Induration (Head/Neck) (n=43, 39, 82) -1.7  (0.97) -1.6  (0.99) -1.6  (0.98)
Week 28: Induration (Upper Limbs) (n=43, 39, 82) -2.0  (1.12) -1.7  (1.10) -1.9  (1.12)
Week 28: Induration (Trunk) (n=43, 39, 82) -2.0  (1.12) -1.8  (1.16) -1.9  (1.14)
Week 28: Induration (Lower Limbs) (n=43, 39, 82) -2.2  (1.03) -1.8  (1.14) -2.0  (1.09)
Week 28: Scaling (Head/Neck) (n=43, 39, 82) -1.7  (1.01) -1.4  (1.07) -1.6  (1.04)
Week 28: Scaling (Upper Limbs) (n=43, 39, 82) -1.8  (1.05) -1.6  (1.02) -1.7  (1.03)
Week 28: Scaling (Trunk) (n=43, 39, 82) -1.7  (0.99) -1.8  (1.11) -1.7  (1.05)
Week 28: Scaling (Lower Limbs) (n=43, 39, 82) -1.8  (1.09) -1.7  (1.02) -1.7  (1.05)
Week 40: Erythema (Head/Neck) (n=41, 38, 79) -1.9  (1.10) -1.7  (0.90) -1.8  (1.01)
Week 40: Erythema (Upper Limbs) (n=41, 38, 79) -2.1  (1.05) -1.9  (1.06) -2.0  (1.06)
Week 40: Erythema (Trunk) (n=41, 38, 79) -2.1  (1.04) -2.2  (0.87) -2.2  (0.95)
Week 40: Erythema (Lower Limbs) (n=41, 38, 79) -2.4  (1.05) -2.0  (1.03) -2.2  (1.05)
Week 40: Induration (Head/Neck) (n=41, 38, 79) -1.7  (1.05) -1.5  (1.08) -1.6  (1.07)
Week 40: Induration (Upper Limbs) (n=41, 38, 79) -2.0  (1.18) -1.8  (0.98) -1.9  (1.09)
Week 40: Induration (Trunk) (n=41, 38, 79) -1.9  (1.26) -2.1  (0.93) -2.1  (1.11)
Week 40: Induration (Lower Limbs) (n=41, 38, 79) -2.2  (1.14) -1.9  (1.03) -2.1  (1.10)
Week 40: Scaling (Head/Neck) (n=41, 38, 79) -1.8  (0.97) -1.4  (1.00) -1.6  (0.99)
Week 40: Scaling (Upper Limbs) (n=41, 38, 79) -1.7  (1.10) -1.8  (0.94) -1.7  (1.02)
Week 40: Scaling (Trunk) (n=41, 38, 79) -1.7  (0.93) -1.9  (1.03) -1.8  (0.98)
Week 40: Scaling (Lower Limbs) (n=41, 38, 79) -1.9  (1.11) -1.8  (1.06) -1.8  (1.08)
Week 52: Erythema (Head/Neck) (n=39, 32, 71) -1.9  (1.17) -1.6  (1.24) -1.8  (1.20)
Week 52: Erythema (Upper Limbs) (n=39, 32, 71) -2.0  (1.15) -2.0  (0.90) -2.0  (1.04)
Week 52: Erythema (Trunk) (n=39, 32, 71) -2.2  (1.01) -2.2  (0.93) -2.2  (0.97)
Week 52: Erythema (Lower Limbs) (n=39, 32, 71) -2.1  (1.11) -2.2  (0.94) -2.1  (1.03)
Week 52: Induration (Head/Neck) (n=39, 32, 71) -1.7  (1.06) -1.5  (1.22) -1.6  (1.13)
Week 52: Induration (Upper Limbs) (n=39, 32, 71) -1.9  (1.21) -2.0  (0.97) -1.9  (1.10)
Week 52: Induration (Trunk) (n=39, 32, 71) -1.8  (1.39) -2.1  (1.03) -2.0  (1.24)
Week 52: Induration (Lower Limbs) (n=39, 32, 71) -2.0  (1.29) -2.2  (0.97) -2.1  (1.15)
Week 52: Scaling (Head/Neck) (n=39, 32, 71) -1.8  (0.98) -1.6  (1.08) -1.7  (1.02)
Week 52: Scaling (Upper Limbs) (n=39, 32, 71) -1.6  (1.02) -1.9  (0.98) -1.7  (1.01)
Week 52: Scaling (Trunk) (n=39, 32, 71) -1.6  (0.96) -1.9  (1.01) -1.7  (0.98)
Week 52: Scaling (Lower Limbs) (n=39, 32, 71) -1.7  (1.15) -2.0  (1.03) -1.8  (1.10)
16.Secondary Outcome
Title Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Hide Description The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Time Frame Week 2, 4, 8, 12, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 7.0 15.9 11.5
Week 4 30.2 38.6 34.5
Week 8 58.1 61.4 59.8
Week 12 72.1 75.0 73.6
Week 20 72.1 59.1 65.5
Week 28 67.4 54.5 60.9
Week 40 67.4 54.5 60.9
Week 52 58.1 56.8 57.5
17.Secondary Outcome
Title Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Hide Description The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2: Clear 0 0 0
Week 2: Almost Clear 7.0 15.9 11.5
Week 2: Mild 39.5 43.2 41.4
Week 2: Moderate 46.5 34.1 40.2
Week 2: Severe 7.0 6.8 6.9
Week 4: Clear 0 11.4 5.7
Week 4: Almost Clear 30.2 27.3 28.7
Week 4: Mild 44.2 40.9 42.5
Week 4: Moderate 18.6 20.5 19.5
Week 4: Severe 7.0 0 3.4
Week 8: Clear (n=43, 41, 84) 7.0 26.8 16.7
Week 8: Almost Clear (n=43, 41, 84) 51.2 39.0 45.2
Week 8: Mild (n=43, 41, 84) 27.9 24.4 26.2
Week 8: Moderate (n=43, 41, 84) 14.0 9.8 11.9
Week 8: Severe (n=43, 41, 84) 0 0 0
Week 12: Clear (n=43, 41, 84) 14.0 36.6 25.0
Week 12: Almost Clear (n=43, 41, 84) 58.1 43.9 51.2
Week 12: Mild (n=43, 41, 84) 20.9 9.8 15.5
Week 12: Moderate (n=43, 41, 84) 7.0 9.8 8.3
Week 12: Severe (n=43, 41, 84) 0 0 0
Week 16: Clear (n=43, 40, 83) 27.9 40.0 33.7
Week 16: Almost Clear (n=43, 40, 83) 39.5 35.0 37.3
Week 16: Mild (n=43, 40, 83) 25.6 17.5 21.7
Week 16: Moderate (n=43, 40, 83) 7.0 5.0 6.0
Week 16: Severe (n=43, 40, 83) 0 2.5 1.2
Week 20: Clear (n=43, 39, 82) 27.9 38.5 32.9
Week 20: Almost Clear (n=43, 39, 82) 44.2 28.2 36.6
Week 20: Mild (n=43, 39, 82) 18.6 25.6 22.0
Week 20: Moderate (n=43, 39, 82) 9.3 7.7 8.5
Week 20: Severe(n=43, 39, 82) 0 0 0
Week 28: Clear (n=43, 39, 82) 37.2 33.3 35.4
Week 28: Almost Clear (n=43, 39, 82) 30.2 28.2 29.3
Week 28: Mild (n=43, 39, 82) 27.9 30.8 29.3
Week 28: Moderate (n=43, 39, 82) 4.7 7.7 6.1
Week 28: Severe (n=43, 39, 82) 0 0 0
Week 40: Clear (n=41, 38, 79) 43.9 34.2 39.2
Week 40: Almost Clear (n=41, 38, 79) 26.8 28.9 27.8
Week 40: Mild (n=41, 38, 79) 24.4 28.9 26.6
Week 40: Moderate (n=41, 38, 79) 4.9 7.9 6.3
Week 40: Severe (n=41, 38, 79) 0 0 0
Week 52: Clear (n=39, 32, 71) 41.0 43.8 42.3
Week 52: Almost Clear (n=39, 32, 71) 23.1 34.4 28.2
Week 52: Mild (n=39, 32, 71) 30.8 18.8 25.4
Week 52: Moderate (n=39, 32, 71) 5.1 3.1 4.2
Week 52: Severe (n=39, 32, 71) 0 0 0
18.Secondary Outcome
Title Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16
Hide Description The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among participants achieving PASI75 response at Week 16 is reported.
Time Frame Week 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 28 35 63
Measure Type: Number
Unit of Measure: Percentage of participants
Week 20 96.3 87.5 91.5
Week 28 92.6 78.1 84.7
Week 40 81.5 71.9 76.3
Week 52 70.4 62.5 66.1
19.Secondary Outcome
Title Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Hide Description The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported.
Time Frame Week 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 30 31 61
Measure Type: Number
Unit of Measure: Percentage of participants
Week 20 100 83.3 91.5
Week 28 93.1 73.3 83.1
Week 40 82.8 66.7 74.6
Week 52 65.5 60.0 62.7
20.Secondary Outcome
Title Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Hide Description The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Time Frame Week 8, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 32 30 62
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 8 (n=32, 28, 60) -3.3  (9.63) -1.8  (7.72) -2.6  (8.75)
Week 16 (n=32, 28, 60) -11.2  (15.27) -9.4  (12.66) -10.4  (14.02)
Week 20 (n=32, 27, 59) -15.0  (15.29) -14.1  (13.03) -14.6  (14.18)
Week 28 (n=32, 27, 59) -21.1  (15.83) -16.4  (15.27) -18.9  (15.62)
Week 40 (n=31, 26, 57) -22.2  (16.18) -16.2  (14.13) -19.5  (15.45)
Week 52 (n=30, 22, 52) -20.6  (15.16) -16.2  (15.62) -18.7  (15.36)
21.Secondary Outcome
Title Number of Affected Nails
Hide Description Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.
Time Frame Baseline, Week 8, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 32 30 62
Mean (Standard Deviation)
Unit of Measure: nails
Baseline 7.94  (2.82) 7.13  (3.07) 7.55  (2.95)
Week 8 (n=32, 28, 60) 7.66  (3.17) 7.11  (3.02) 7.40  (3.09)
Week 16 (n=32, 28, 60) 6.91  (3.43) 5.75  (3.56) 6.37  (3.51)
Week 20 (n=32, 27, 59) 6.16  (3.60) 4.59  (4.02) 5.44  (3.85)
Week 28 (n=32, 27, 59) 4.53  (3.87) 3.59  (3.96) 4.10  (3.91)
Week 40 (n=31, 26, 57) 3.32  (3.94) 3.77  (3.81) 3.53  (3.85)
Week 52 (n=30, 22, 52) 3.73  (4.25) 2.50  (3.07) 3.21  (3.81)
22.Secondary Outcome
Title Itch Severity Item (ISI) Score
Hide Description ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.
Time Frame Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 6.16  (2.669) 5.32  (2.967) 5.74  (2.839)
Week 2 5.19  (2.797) 3.30  (2.530) 4.23  (2.815)
Week 4 3.65  (2.379) 2.27  (2.472) 2.95  (2.510)
Week 8 (n=43, 41, 84) 2.26  (2.381) 1.22  (1.739) 1.75  (2.145)
Week 12 (n=43, 41, 84) 1.77  (2.379) 1.20  (1.833) 1.49  (2.137)
Week 16 (n=43, 40, 83) 1.67  (2.378) 0.90  (1.257) 1.30  (1.949)
Week 20 (n=43, 39, 82) 0.95  (1.618) 1.28  (1.589) 1.11  (1.603)
Week 28 (n=43, 39, 82) 1.12  (1.651) 1.62  (2.196) 1.35  (1.933)
Week 40 (n=41, 38, 79) 0.90  (1.814) 1.13  (1.848) 1.01  (1.822)
Week 52 (n=39, 32, 71) 1.15  (2.084) 0.91  (1.329) 1.04  (1.776)
23.Secondary Outcome
Title Dermatology Life Quality Index (DLQI) Score
Hide Description The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time Frame Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 11.3  (6.25) 8.6  (5.91) 9.9  (6.19)
Week 2 7.8  (5.20) 5.8  (5.32) 6.8  (5.32)
Week 4 (n=43, 43, 86) 5.9  (5.07) 4.2  (4.63) 5.1  (4.90)
Week 8 (n=43, 41, 84) 4.0  (3.95) 2.8  (3.30) 3.4  (3.67)
Week 12 (n=43, 41, 84) 2.6  (2.86) 1.8  (2.68) 2.2  (2.79)
Week 16 (n=43, 40, 83) 2.2  (3.04) 1.9  (2.73) 2.1  (2.88)
Week 20 (n=43, 39, 82) 1.9  (3.13) 1.8  (2.54) 1.9  (2.84)
Week 28 (n=43, 39, 82) 1.7  (2.66) 2.9  (3.68) 2.3  (3.23)
Week 40 (n=41, 38, 79) 1.8  (2.81) 2.3  (4.11) 2.0  (3.48)
Week 52 (n=39, 32, 71) 1.6  (2.42) 2.2  (4.00) 1.9  (3.22)
24.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
Hide Description 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Time Frame Week (W) 16, 28, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
W16: Physical Functioning Domain (n=43, 40, 83) 1.951  (5.1880) 4.809  (9.1822) 3.329  (7.4800)
W16: Role-Physical Domain (n=43, 40, 83) 6.160  (9.3615) 5.130  (11.1600) 5.664  (10.2172)
W16: Bodily Pain Domain (n=43, 40, 83) 11.808  (13.8431) 10.663  (12.2936) 11.256  (13.0524)
W16: General Health Domain (n=43, 40, 83) 2.392  (7.0933) 4.333  (7.0145) 3.328  (7.0799)
W16: Vitality Domain (n=43, 40, 83) 4.664  (9.5406) 3.517  (11.4421) 4.112  (10.4509)
W16: Social Function Domain (n=43, 40, 83) 7.629  (9.9734) 7.932  (8.8645) 7.775  (9.3992)
W16: Role-Emotional Domain (n=43, 40, 83) 7.219  (11.5898) 5.584  (11.5654) 6.431  (11.5365)
W16: Mental Health Domain (n=43, 40, 83) 5.928  (12.8757) 5.125  (13.3613) 5.541  (13.0378)
W28: Physical Functioning Domain (n=43, 39, 82) 1.571  (6.3446) 4.303  (10.3695) 2.870  (8.5558)
W28: Role-Physical Domain (n=43, 39, 82) 5.882  (10.6375) 5.017  (11.4671) 5.471  (10.9795)
W28: Bodily Pain Domain (n=43, 39, 82) 10.113  (15.9485) 8.394  (12.5405) 9.295  (14.3670)
W28: General Health Domain (n=43, 39, 82) 2.644  (5.9230) 3.517  (7.1375) 3.059  (6.5025)
W28: Vitality Domain (n=43, 39, 82) 4.038  (10.0116) 3.608  (10.0742) 3.833  (9.9815)
W28: Social Function Domain (n=43, 39, 82) 6.628  (11.3068) 6.205  (10.4347) 6.427  (10.8358)
W28: Role-Emotional Domain (n=43, 39, 82) 7.395  (11.8846) 6.310  (12.9504) 6.879  (12.3375)
W28: Mental Health Domain (n=43, 39, 82) 6.701  (12.4375) 5.328  (12.8129) 6.048  (12.5580)
W52: Physical Functioning Domain (n=39,32,71) 2.151  (5.6134) 3.773  (7.3533) 2.882  (6.4585)
W52: Role-Physical Domain (n=39, 32, 71) 6.669  (10.0520) 4.623  (9.7340) 5.747  (9.8926)
W52: Bodily Pain Domain (n=39, 32, 71) 12.335  (12.1413) 10.673  (9.7128) 11.586  (11.0678)
W52: General Health Domain (n=39, 32, 71) 2.758  (6.0866) 4.888  (6.8235) 3.718  (6.4707)
W52: Vitality Domain (n=39, 32, 71) 4.068  (10.5612) 5.052  (8.5160) 4.511  (9.6390)
W52: Social Function Domain (n=39, 32, 71) 8.411  (9.4598) 8.402  (9.2577) 8.407  (9.3024)
W52: Role-Emotional Domain (n=39, 32, 71) 8.445  (11.0018) 5.915  (10.3091) 7.305  (10.6949)
W52: Mental Health Domain (n=39, 32, 71) 7.317  (11.6243) 6.926  (12.6861) 7.141  (12.0276)
25.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score
Hide Description 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Time Frame Week 16, 28, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 16: Physical Health Score (n=43, 40, 83) 4.719  (6.6806) 6.146  (8.5192) 5.407  (7.6087)
Week 16: Mental Health Score (n=43, 40, 83) 6.767  (11.0945) 5.029  (11.4967) 5.929  (11.2548)
Week 28: Physical Health Score (n=43, 39, 82) 3.770  (7.7829) 4.799  (8.8893) 4.259  (8.2914)
Week 28: Mental Health Score (n=43, 39, 82) 7.085  (11.3660) 5.364  (10.9089) 6.266  (11.1159)
Week 52: Physical Health Score (n=39, 32, 71) 4.676  (5.7405) 5.250  (5.7614) 4.935  (5.7159)
Week 52: Mental Health Score (n=39, 32, 71) 7.878  (10.1983) 6.826  (10.5988) 7.404  (10.3192)
26.Secondary Outcome
Title Work Limitation Questionnaire (WLQ)
Hide Description WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).
Time Frame Baseline (BL), Week (W) 4, 16, 28, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
BL: Time Management scale (n=34, 37, 71) 44.49  (37.783) 42.36  (33.716) 43.38  (35.479)
BL: Physical Demands scale (n=33, 35, 68) 66.67  (33.522) 78.40  (31.122) 72.71  (32.606)
BL: Mental/Interpersonal Demands Scale(n=34,38,72) 28.61  (29.012) 31.52  (30.930) 30.15  (29.865)
BL: Output Demands scale (n=33, 37, 70) 22.61  (26.832) 30.27  (35.295) 26.66  (31.602)
BL: WLQ Index Score (n=34, 38, 72) 9.55  (6.716) 10.74  (8.045) 10.18  (7.420)
W4: Time Management scale (n=31, 36, 67) 35.32  (42.425) 31.39  (36.715) 33.21  (39.203)
W4: Physical Demands scale (n=29, 36, 65) 77.16  (33.013) 83.59  (29.593) 80.72  (31.083)
W4:Mental/Interpersonal Demands Scale(n=32,36,68) 17.94  (26.979) 23.39  (32.878) 20.82  (30.149)
W4: Output Demands scale (n=30, 36, 66) 13.50  (21.978) 20.14  (33.306) 17.12  (28.704)
W4: WLQ Index Score (n=32, 37, 69) 7.23  (5.591) 8.66  (7.754) 8.00  (6.827)
W16: Time Management scale (n=31, 35, 66) 35.07  (38.894) 33.29  (39.182) 34.12  (38.756)
W16: Physical Demands scale (n=30, 32, 62) 81.60  (26.982) 86.52  (25.548) 84.14  (26.153)
W16:Mental/Interpersonal Demands Scale(n=31,35,66) 13.33  (21.038) 20.28  (33.419) 17.01  (28.296)
W16: Output Demands scale (n=32, 33, 65) 11.88  (20.111) 19.55  (32.485) 15.77  (27.175)
W16: WLQ Index Score (n=32, 35, 67) 6.88  (4.715) 8.35  (7.425) 7.65  (6.276)
W28: Time Management scale (n=34, 34, 68) 38.68  (40.100) 29.78  (39.092) 34.23  (39.557)
W28: Physical Demands scale (n=32, 34, 66) 76.02  (31.041) 85.42  (24.730) 80.86  (28.151)
W28:Mental/Interpersonal Demands Scale(n=33,35,68) 16.84  (28.242) 16.39  (27.736) 16.61  (27.774)
W28: Output Demands scale (n=33, 34, 67) 13.94  (27.408) 14.71  (28.761) 14.33  (27.892)
W28: WLQ Index Score (n=34, 36, 70) 7.43  (6.493) 7.26  (6.829) 7.34  (6.620)
W52: Time Management scale (n=31, 31, 62) 50.32  (43.683) 31.88  (40.686) 41.10  (42.883)
W52: Physical Demands scale (n=29, 29, 58) 78.16  (30.205) 89.74  (24.410) 83.95  (27.838)
W52:Mental/Interpersonal Demands Scale(n=30,30,60) 25.56  (36.007) 16.89  (27.293) 21.22  (31.977)
W52: Output Demands scale (n=30, 29, 59) 22.63  (33.750) 12.24  (24.589) 17.52  (29.813)
W52: WLQ Index Score (n=32, 31, 63) 9.44  (8.127) 7.34  (6.429) 8.41  (7.358)
27.Secondary Outcome
Title Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Hide Description The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Time Frame Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 43 44 87
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline: Clear 0 0 0
Baseline: Almost Clear 0 0 0
Baseline: Mild 0 2.3 1.1
Baseline: Moderate 41.9 43.2 42.5
Baseline: Severe 58.1 54.5 56.3
Week 2: Clear 0 0 0
Week 2: Almost Clear 2.3 0 1.1
Week 2: Mild 2.3 29.5 16.1
Week 2: Moderate 60.5 36.4 48.3
Week 2: Severe 34.9 34.1 34.5
Week 4: Clear (n=43, 43, 86) 0 2.3 1.2
Week 4: Almost Clear (n=43, 43, 86) 4.7 9.3 7.0
Week 4: Mild (n=43, 43, 86) 18.6 25.6 22.1
Week 4: Moderate (n=43, 43, 86) 53.5 48.8 51.2
Week 4: Severe (n=43, 43, 86) 23.3 14.0 18.6
Week 8: Clear (n=43, 41, 84) 4.7 7.3 6.0
Week 8: Almost Clear (n=43, 41, 84) 14.0 17.1 15.5
Week 8: Mild (n=43, 41, 84) 32.6 34.1 33.3
Week 8: Moderate (n=43, 41, 84) 39.5 34.1 36.9
Week 8: Severe (n=43, 41, 84) 9.3 7.3 8.3
Week 12: Clear (n=43, 41, 84) 2.3 7.3 4.8
Week 12: Almost Clear (n=43, 41, 84) 20.9 26.8 23.8
Week 12: Mild (n=43, 41, 84) 34.9 41.5 38.1
Week 12: Moderate (n=43, 41, 84) 34.9 17.1 26.2
Week 12: Severe (n=43, 41, 84) 7.0 7.3 7.1
Week 16: Clear (n=43, 40, 83) 4.7 10.0 7.2
Week 16: Almost Clear (n=43, 40, 83) 32.6 22.5 27.7
Week 16: Mild (n=43, 40, 83) 23.3 35.0 28.9
Week 16: Moderate (n=43, 40, 83) 32.6 22.5 27.7
Week 16: Severe (n=43, 40, 83) 7.0 10.0 8.4
Week 20: Clear (n=43, 39, 82) 7.0 12.8 9.8
Week 20: Almost Clear (n=43, 39, 82) 37.2 23.1 30.5
Week 20: Mild (n=43, 39, 82) 25.6 33.3 29.3
Week 20: Moderate (n=43, 39, 82) 23.3 25.6 24.4
Week 20: Severe (n=43, 39, 82) 7.0 5.1 6.1
Week 28: Clear (n=43, 39, 82) 11.6 5.1 8.5
Week 28: Almost Clear (n=43, 39, 82) 37.2 35.9 36.6
Week 28: Mild (n=43, 39, 82) 23.3 20.5 22.0
Week 28: Moderate (n=43, 39, 82) 20.9 33.3 26.8
Week 28: Severe (n=43, 39, 82) 7.0 5.1 6.1
Week 40: Clear (n=41, 38, 79) 7.3 18.4 12.7
Week 40: Almost Clear (n=41, 38, 79) 46.3 31.6 39.2
Week 40: Mild (n=41, 38, 79) 19.5 18.4 19.0
Week 40: Moderate (n=41, 38, 79) 22.0 26.3 24.1
Week 40: Severe (n=41, 38, 79) 4.9 5.3 5.1
Week 52: Clear (n=39, 32, 71) 20.5 18.8 19.7
Week 52: Almost Clear (n=39, 32, 71) 20.5 31.3 25.4
Week 52: Mild (n=39, 32, 71) 28.2 25.0 26.8
Week 52: Moderate (n=39, 32, 71) 15.4 21.9 18.3
Week 52: Severe (n=39, 32, 71) 15.4 3.1 9.9
28.Secondary Outcome
Title Joint Pain Assessment (JPA)
Hide Description The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to "select the number that best describes any joint pain that participant may have experienced over the past 24 hours" with response options ranging from "0-no joint pain" to "10-worst possible joint pain."
Time Frame Baseline, Week 4, 16, 28, 52
Hide Outcome Measure Data
Hide Analysis Population Description
The subjects with a medical history of ongoing psoriatic arthritis (that was defined as the MedDRA preferred term for psoriatic arthropathy regardless of meeting the inclusion criteria for the psoriatic arthritis) in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 8 15 23
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 5.25  (3.327) 4.60  (2.558) 4.83  (2.790)
Week 4 (n=8, 14, 22) 4.00  (2.726) 1.36  (1.008) 2.32  (2.191)
Week 16 (n=8, 15, 23) 1.88  (2.295) 0.60  (0.737) 1.04  (1.551)
Week 28 (n=8, 14, 22) 1.75  (1.753) 0.86  (0.949) 1.18  (1.332)
Week 52 (n=4, 13, 17) 0.50  (0.577) 0.54  (0.660) 0.53  (0.624)
29.Secondary Outcome
Title Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Hide Description ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame Week 2, 4, 8, 12, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 4 8 12
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 0.0 62.5 41.7
Week 4 50.0 75.0 66.7
Week 8 75.0 100 91.7
Week 12 100 87.5 91.7
Week 20 100 87.5 91.7
Week 28 100 100 100
Week 40 75.0 100 91.7
Week 52 50.0 100 83.3
30.Secondary Outcome
Title Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Hide Description ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 4 8 12
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 0.0 25.0 16.7
Week 4 25.0 50.0 41.7
Week 8 50.0 62.5 58.3
Week 12 75.0 75.0 75.0
Week 16 75.0 87.5 83.3
Week 20 100 87.5 91.7
Week 28 100 75.0 83.3
Week 40 75.0 87.5 83.3
Week 52 50.0 87.5 75.0
31.Secondary Outcome
Title Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Hide Description ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 4 8 12
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 0.0 0.0 0.0
Week 4 0.0 37.5 25.0
Week 8 25.0 62.5 50.0
Week 12 50.0 62.5 58.3
Week 16 50.0 62.5 58.3
Week 20 75.0 75.0 75.0
Week 28 75.0 50.0 58.3
Week 40 50.0 75.0 66.7
Week 52 50.0 75.0 66.7
32.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Hide Description Sixty eight (68) joints were assessed by a rheumatologist investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 4 8 12
Mean (Standard Deviation)
Unit of Measure: Tender/painful joints
Week 2 -1.8  (1.50) -3.5  (2.78) -2.9  (2.50)
Week 4 -6.3  (6.70) -9.3  (11.37) -8.3  (9.84)
Week 8 -11.5  (10.08) -11.6  (10.24) -11.6  (9.72)
Week 12 -13.8  (10.78) -12.5  (11.95) -12.9  (11.09)
Week 16 -13.0  (9.59) -13.0  (12.17) -13.0  (10.92)
Week 20 -14.3  (9.11) -12.4  (12.87) -13.0  (11.35)
Week 28 -14.0  (9.38) -12.4  (12.52) -12.9  (11.16)
Week 40 -14.3  (10.14) -13.4  (12.09) -13.7  (11.02)
Week 52 (n=3, 8, 11) -11.3  (9.24) -13.5  (12.08) -12.9  (10.97)
33.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Hide Description Sixty six (66) joints were assessed for swelling by a rheumatologist investigator to determine the number of joints that were considered swelling. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 4 8 12
Mean (Standard Deviation)
Unit of Measure: Swollen joints
Week 2 -1.8  (2.22) -3.8  (5.55) -3.1  (4.68)
Week 4 -5.0  (4.69) -5.3  (5.80) -5.2  (5.24)
Week 8 -6.0  (7.35) -6.4  (4.37) -6.3  (5.19)
Week 12 -6.5  (6.35) -7.0  (4.44) -6.8  (4.86)
Week 16 -7.3  (7.85) -7.8  (3.85) -7.6  (5.12)
Week 20 -7.0  (8.00) -8.9  (4.42) -8.3  (5.55)
Week 28 -7.3  (7.85) -7.6  (4.03) -7.5  (5.21)
Week 40 -7.3  (7.85) -8.8  (4.20) -8.3  (5.34)
Week 52 (n=3, 8, 11) -3.0  (0.00) -8.8  (4.13) -7.2  (4.38)
34.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Hide Description Subjects assessed the severity of their arthritis pain with a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (the most severe pain), which corresponded to the magnitude of their pain.
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 4 8 12
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 2 -13.3  (8.30) -29.5  (23.40) -24.1  (20.77)
Week 4 -13.0  (23.41) -41.4  (25.29) -31.9  (27.42)
Week 8 -16.0  (19.78) -43.6  (22.68) -34.4  (24.88)
Week 12 -34.5  (19.71) -46.0  (23.42) -42.2  (22.07)
Week 16 -27.3  (15.22) -46.0  (22.44) -39.8  (21.65)
Week 20 -44.0  (22.82) -45.3  (21.53) -44.8  (20.91)
Week 28 -45.8  (23.26) -45.8  (20.46) -45.8  (20.34)
Week 40 -20.0  (54.86) -46.9  (22.66) -37.9  (36.37)
Week 52 (n=3, 8, 11) -33.0  (31.19) -48.4  (22.14) -44.2  (24.28)
35.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Hide Description Subjects answered the following question, "Considering the possible effects of the arthritis, how are you feeling today?" The subject's response was recorded with a 100 mm visual analog scale (VAS), where 0 = very well and 100 = very poorly.
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 4 8 12
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 2 -8.0  (8.87) -32.6  (27.55) -24.4  (25.53)
Week 4 -20.5  (11.27) -43.4  (27.47) -35.8  (25.33)
Week 8 -23.3  (19.69) -51.3  (20.53) -41.9  (23.75)
Week 12 -45.0  (8.83) -52.1  (21.35) -49.8  (17.99)
Week 16 -40.0  (13.64) -53.0  (20.96) -48.7  (19.27)
Week 20 -49.5  (20.09) -49.6  (20.26) -49.6  (19.27)
Week 28 -52.3  (11.18) -46.3  (26.67) -48.3  (22.26)
Week 40 -20.8  (30.24) -50.8  (20.78) -40.8  (27.24)
Week 52 (n=3, 8, 11) -40.7  (16.80) -55.3  (20.51) -51.3  (19.94)
36.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
Hide Description The rheumatologist investigator assessed how the subject's overall arthritis appeared at the time of the visit. This was an evaluation based on the subject's disease signs, functional capacity and physical examination, and was independent of the PGA of arthritis. The rheumatologist investigator's response was recorded a 100 mm visual analog scale (VAS), where 0 = very good and 100 = very poor.
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 4 8 12
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 2 -15.3  (18.01) -28.5  (18.60) -24.1  (18.74)
Week 4 -32.5  (22.28) -34.6  (19.39) -33.9  (19.38)
Week 8 -29.5  (30.01) -41.8  (21.87) -37.7  (24.21)
Week 12 -39.8  (21.00) -45.8  (22.76) -43.8  (21.42)
Week 16 -49.8  (23.34) -47.9  (20.09) -48.5  (20.16)
Week 20 -50.8  (25.29) -45.3  (26.81) -47.1  (25.28)
Week 28 -49.5  (25.96) -42.8  (22.79) -45.0  (22.92)
Week 40 -38.5  (39.03) -49.5  (18.54) -45.8  (25.76)
Week 52 (n=3, 8, 11) -29.0  (20.30) -46.8  (25.08) -41.9  (24.32)
37.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
Hide Description The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory.
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 4 8 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 2 -1.20  (2.137) -1.68  (2.231) -1.52  (2.114)
Week 4 -1.20  (2.267) -1.69  (2.272) -1.53  (2.178)
Week 8 -1.28  (2.354) -1.70  (2.222) -1.56  (2.167)
Week 12 -1.28  (2.351) -1.68  (2.235) -1.54  (2.174)
Week 16 -1.30  (2.337) -1.69  (2.189) -1.56  (2.139)
Week 20 -1.33  (2.387) -1.59  (2.336) -1.50  (2.246)
Week 28 -1.30  (2.337) -1.15  (2.770) -1.20  (2.526)
Week 40 (n=4, 7, 11) -1.15  (2.037) -1.84  (2.461) -1.59  (2.236)
Week 52 (n=3, 8, 11) -0.03  (0.058) -1.65  (2.295) -1.21  (2.064)
38.Secondary Outcome
Title Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
Hide Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Time Frame Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
(=sum across Arm/Groups)
Overall Number of Participants Analyzed 4 8 12
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 2 -0.19  (0.239) -0.28  (0.376) -0.25  (0.329)
Week 4 -0.28  (0.329) -0.36  (0.381) -0.33  (0.351)
Week 8 -0.28  (0.359) -0.42  (0.433) -0.38  (0.399)
Week 12 -0.28  (0.359) -0.42  (0.433) -0.38  (0.399)
Week 16 -0.31  (0.375) -0.42  (0.433) -0.39  (0.400)
Week 20 -0.28  (0.359) -0.42  (0.433) -0.38  (0.399)
Week 28 -0.34  (0.400) -0.42  (0.433) -0.40  (0.405)
Week 40 -0.09  (0.640) -0.42  (0.433) -0.31  (0.507)
Week 52 (n=3, 8, 11) -0.13  (0.573) -0.42  (0.433) -0.34  (0.465)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52. CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52. (=sum across Arm/Groups)
All-Cause Mortality
CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/47 (6.38%)   3/47 (6.38%)   6/94 (6.38%) 
Ear and labyrinth disorders       
Vertigo * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Infections and infestations       
Herpes zoster * 1  3/47 (6.38%)  0/47 (0.00%)  3/94 (3.19%) 
Impetigo * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Skin and subcutaneous tissue disorders       
Erythrodermic psoriasis * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Psoriasis * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/47 (78.72%)   40/47 (85.11%)   77/94 (81.91%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Lymphadenitis * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Lymphadenopathy * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Ear and labyrinth disorders       
Vertigo * 1  0/47 (0.00%)  2/47 (4.26%)  2/94 (2.13%) 
Eye disorders       
Asthenopia * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Cataract * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Conjunctival deposit * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Eyelid oedema * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Presbyopia * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Abdominal pain upper * 1  2/47 (4.26%)  1/47 (2.13%)  3/94 (3.19%) 
Colitis * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Constipation * 1  1/47 (2.13%)  1/47 (2.13%)  2/94 (2.13%) 
Dental caries * 1  3/47 (6.38%)  1/47 (2.13%)  4/94 (4.26%) 
Diarrhoea * 1  0/47 (0.00%)  2/47 (4.26%)  2/94 (2.13%) 
Gastrooesophageal reflux disease * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Lip erosion * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Nausea * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Toothache * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
General disorders       
Fatigue * 1  1/47 (2.13%)  1/47 (2.13%)  2/94 (2.13%) 
Malaise * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Oedema * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Oedema peripheral * 1  1/47 (2.13%)  2/47 (4.26%)  3/94 (3.19%) 
Pyrexia * 1  0/47 (0.00%)  3/47 (6.38%)  3/94 (3.19%) 
Hepatobiliary disorders       
Hepatic function abnormal * 1  2/47 (4.26%)  2/47 (4.26%)  4/94 (4.26%) 
Infections and infestations       
Bronchitis * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Enteritis infectious * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Folliculitis * 1  2/47 (4.26%)  2/47 (4.26%)  4/94 (4.26%) 
Furuncle * 1  1/47 (2.13%)  1/47 (2.13%)  2/94 (2.13%) 
Gastroenteritis * 1  3/47 (6.38%)  0/47 (0.00%)  3/94 (3.19%) 
Gastroenteritis norovirus * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Gastroenteritis viral * 1  0/47 (0.00%)  2/47 (4.26%)  2/94 (2.13%) 
Herpes zoster * 1  3/47 (6.38%)  10/47 (21.28%)  13/94 (13.83%) 
Hordeolum * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Influenza * 1  3/47 (6.38%)  3/47 (6.38%)  6/94 (6.38%) 
Nasopharyngitis * 1  14/47 (29.79%)  14/47 (29.79%)  28/94 (29.79%) 
Oral herpes * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Otitis media acute * 1  1/47 (2.13%)  1/47 (2.13%)  2/94 (2.13%) 
Periodontitis * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Pertussis * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Pharyngitis * 1  0/47 (0.00%)  2/47 (4.26%)  2/94 (2.13%) 
Pneumonia * 1  1/47 (2.13%)  1/47 (2.13%)  2/94 (2.13%) 
Rhinitis * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Salpingitis * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Sinusitis * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Subcutaneous abscess * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Tinea infection * 1  1/47 (2.13%)  1/47 (2.13%)  2/94 (2.13%) 
Tinea pedis * 1  4/47 (8.51%)  6/47 (12.77%)  10/94 (10.64%) 
Tinea versicolour * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Upper respiratory tract infection * 1  2/47 (4.26%)  0/47 (0.00%)  2/94 (2.13%) 
Vaginitis gardnerella * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Injury, poisoning and procedural complications       
Arthropod bite * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Arthropod sting * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Epicondylitis * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Excoriation * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Fall * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Hand fracture * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Muscle strain * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Rib fracture * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Thermal burn * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Traumatic haematoma * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Investigations       
Alanine aminotransferase increased * 1  1/47 (2.13%)  3/47 (6.38%)  4/94 (4.26%) 
Aspartate aminotransferase increased * 1  1/47 (2.13%)  2/47 (4.26%)  3/94 (3.19%) 
Blood bilirubin increased * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Blood cholesterol increased * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Blood creatine phosphokinase increased * 1  3/47 (6.38%)  2/47 (4.26%)  5/94 (5.32%) 
Blood triglycerides increased * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Gamma-glutamyltransferase increased * 1  0/47 (0.00%)  3/47 (6.38%)  3/94 (3.19%) 
Haemoglobin decreased * 1  1/47 (2.13%)  4/47 (8.51%)  5/94 (5.32%) 
Liver function test abnormal * 1  0/47 (0.00%)  2/47 (4.26%)  2/94 (2.13%) 
Low density lipoprotein increased * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Occult blood positive * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Platelet count decreased * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Weight decreased * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Weight increased * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
White blood cell count decreased * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Metabolism and nutrition disorders       
Diabetes mellitus * 1  2/47 (4.26%)  0/47 (0.00%)  2/94 (2.13%) 
Dyslipidaemia * 1  1/47 (2.13%)  1/47 (2.13%)  2/94 (2.13%) 
Hypercholesterolaemia * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Hyperlipidaemia * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/47 (2.13%)  2/47 (4.26%)  3/94 (3.19%) 
Back pain * 1  2/47 (4.26%)  1/47 (2.13%)  3/94 (3.19%) 
Joint swelling * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Musculoskeletal pain * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Myalgia * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital warts * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Seborrhoeic keratosis * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Skin papilloma * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Uterine leiomyoma * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Nervous system disorders       
Cervicobrachial syndrome * 1  1/47 (2.13%)  1/47 (2.13%)  2/94 (2.13%) 
Headache * 1  1/47 (2.13%)  3/47 (6.38%)  4/94 (4.26%) 
Hypoaesthesia * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Neuropathy peripheral * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Post herpetic neuralgia * 1  0/47 (0.00%)  3/47 (6.38%)  3/94 (3.19%) 
Renal and urinary disorders       
Calculus ureteric * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Nephrolithiasis * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Pollakiuria * 1  1/47 (2.13%)  1/47 (2.13%)  2/94 (2.13%) 
Reproductive system and breast disorders       
Atrophic vulvovaginitis * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Cervical polyp * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Endometriosis * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Prostatitis * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Upper respiratory tract inflammation * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Skin and subcutaneous tissue disorders       
Acne * 1  0/47 (0.00%)  3/47 (6.38%)  3/94 (3.19%) 
Alopecia * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Dermatitis contact * 1  2/47 (4.26%)  1/47 (2.13%)  3/94 (3.19%) 
Dyshidrotic eczema * 1  0/47 (0.00%)  1/47 (2.13%)  1/94 (1.06%) 
Eczema * 1  1/47 (2.13%)  1/47 (2.13%)  2/94 (2.13%) 
Hirsutism * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Psoriasis * 1  4/47 (8.51%)  6/47 (12.77%)  10/94 (10.64%) 
Purpura * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Seborrhoeic dermatitis * 1  1/47 (2.13%)  0/47 (0.00%)  1/94 (1.06%) 
Solar dermatitis * 1  2/47 (4.26%)  0/47 (0.00%)  2/94 (2.13%) 
Urticaria * 1  1/47 (2.13%)  2/47 (4.26%)  3/94 (3.19%) 
Vascular disorders       
Hypertension * 1  0/47 (0.00%)  2/47 (4.26%)  2/94 (2.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01519089    
Other Study ID Numbers: A3921137
First Submitted: December 22, 2011
First Posted: January 26, 2012
Results First Submitted: January 8, 2015
Results First Posted: August 13, 2015
Last Update Posted: August 13, 2015