Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan

• ClinicalTrials.gov Identifier: NCT00687193
• Recruitment Status: Completed
• First Posted: May 30, 2008
• Results First Posted: December 25, 2012
• Last Update Posted: March 25, 2013
• Sponsor: Pfizer
• 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: Arthritis, Rheumatoid
• Interventions: Drug: Placebo; Drug: CP-690,550
• Enrollment: 318

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Period Title: Overall Study
Started	53	53	52	53	54	52 [1]
Completed	51	49	50	49	52	48
Not Completed	2	4	2	4	2	4
Reason Not Completed
Adverse Event	0	1	2	3	0	2
Lack of Efficacy	1	1	0	0	0	2
Protocol Violation	1	2	0	1	2	0
[1] One participant withdrew after randomization but prior to treatment.

Baseline Characteristics

Arm/Group Title		CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo	Total
Arm/Group Description		Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		53	53	52	53	54	52	317
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	53 participants	53 participants	52 participants	53 participants	54 participants	52 participants	317 participants
< 18 years		0	0	0	0	0	0	0
Between 18 and 44 years		8	11	13	9	12	14	67
Between 45 and 64 years		39	33	31	32	30	29	194
>= 65 years		6	9	8	12	12	9	56
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	53 participants	53 participants	52 participants	53 participants	54 participants	52 participants	317 participants
	Female	42 79.2%	47 88.7%	44 84.6%	44 83.0%	44 81.5%	43 82.7%	264 83.3%
	Male	11 20.8%	6 11.3%	8 15.4%	9 17.0%	10 18.5%	9 17.3%	53 16.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Description	ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and 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 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Measure Type: Number; Unit of Measure: participants
	20	36	38	45	49	8

2. Secondary Outcome

Title	Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8
Description	ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and 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)at each visit.
Time Frame	Week 2, 4, and 8

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Measure Type: Number; Unit of Measure: participants
Week 2 (LOCF)	10	18	18	35	29	3
Week 4 (LOCF)	19	25	32	43	42	5
Week 8 (LOCF)	20	33	35	46	47	6

3. Secondary Outcome

Title	Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Description	ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in painful and 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) at each visit.
Time Frame	Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	52	53	52	53	54	52
Measure Type: Number; Unit of Measure: participants
Week 2 (LOCF)	1	5	6	17	12	0
Week 4 (LOCF)	5	12	15	29	25	1
Week 8 (LOCF)	6	20	23	33	36	1
Week 12 (LOCF)	7	14	24	37	39	4

4. Secondary Outcome

Title	Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Description	ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in painful and 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) at each visit.
Time Frame	Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Measure Type: Number; Unit of Measure: participants
Week 2 (LOCF)	0	0	1	5	4	0
Week 4 (LOCF)	1	2	9	14	9	0
Week 8 (LOCF)	3	7	13	20	22	1
Week 12 (LOCF)	4	7	14	26	28	1

5. Secondary Outcome

Title	Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
Description	ACR90 response: greater than or equal to (>=) 90 percent (%) improvement in painful and tender joint count; >= 90% improvement in swollen joint count; and >= 90% 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) at each visit.
Time Frame	Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Measure Type: Number; Unit of Measure: participants
Week 2 (LOCF)	0	0	0	0	0	0
Week 4 (LOCF)	0	0	0	2	3	0
Week 8 (LOCF)	0	0	3	7	5	0
Week 12 (LOCF)	0	0	2	8	6	0

6. Secondary Outcome

Title	Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)]
Description	The DAS28-3 (CRP) score is a measure of the perticipant's disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints) and CRP. DAS28-3 (CRP) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity. Change = value at observation minus value at baseline
Time Frame	Baseline, Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks. Missing values were not imputed.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52)	-0.56 (0.13)	-1.03 (0.13)	-1.01 (0.13)	-1.65 (0.13)	-1.63 (0.13)	-0.20 (0.13)
Week 4 (n=52, 51, 51, 52, 52, 52)	-0.82 (0.13)	-1.29 (0.13)	-1.65 (0.13)	-2.33 (0.13)	-2.14 (0.13)	-0.23 (0.13)
Week 8 (n=51, 51, 51, 52, 52, 50)	-0.98 (0.13)	-1.63 (0.13)	-1.95 (0.13)	-2.62 (0.13)	-2.55 (0.13)	-0.15 (0.13)
Week 12 (n=51, 49, 50, 49, 52, 48)	-1.09 (0.13)	-1.71 (0.13)	-2.02 (0.13)	-2.81 (0.13)	-2.70 (0.13)	-0.12 (0.13)

7. Secondary Outcome

Title	Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)]
Description	The DAS28-4 (ESR) score is a measure of the participant's disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints), participant's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity. Change = score at observation minus score at baseline.
Time Frame	Baseline, Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
Week 2 (n=52, 53, 50, 52, 54, 52)	-0.52 (0.15)	-0.93 (0.14)	-1.00 (0.15)	-1.66 (0.15)	-1.58 (0.14)	-0.25 (0.15)
Week 4 (n=52, 51, 51, 52, 52, 51)	-0.79 (0.15)	-1.32 (0.15)	-1.69 (0.15)	-2.42 (0.15)	-2.31 (0.14)	-0.23 (0.15)
Week 8 (n=51, 50, 51, 52, 52, 50)	-1.03 (0.15)	-1.68 (0.15)	-2.05 (0.15)	-2.92 (0.15)	-2.87 (0.14)	-0.12 (0.15)
Week 12 (n=51, 49, 50, 49, 52, 48)	-1.10 (0.15)	-1.74 (0.15)	-2.20 (0.15)	-3.05 (0.15)	-2.98 (0.14)	-0.10 (0.15)

8. Secondary Outcome

Title	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
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. Change = score at observation minus score at baseline.
Time Frame	Baseline, Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52)	-0.10 (0.06)	-0.15 (0.06)	-0.28 (0.06)	-0.39 (0.06)	-0.40 (0.06)	0.06 (0.06)
Week 4 (n=52, 51, 51, 52, 52, 52)	-0.07 (0.06)	-0.25 (0.06)	-0.38 (0.06)	-0.54 (0.06)	-0.51 (0.06)	0.03 (0.06)
Week 8 (n=51, 50, 51, 52, 52, 50)	-0.17 (0.06)	-0.36 (0.06)	-0.49 (0.06)	-0.59 (0.06)	-0.63 (0.06)	0.18 (0.06)
Week 12 (n=51, 49, 50, 49, 52, 48)	-0.19 (0.06)	-0.38 (0.06)	-0.55 (0.06)	-0.67 (0.06)	-0.68 (0.06)	0.18 (0.06)

9. Secondary Outcome

Title	Change From Baseline in Painful and Tender Joint Counts
Description	Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52)	-4.14 (0.98)	-5.13 (0.97)	-5.29 (0.99)	-8.48 (0.98)	-7.73 (0.96)	-2.03 (0.98)
Week 4 (n=52, 51, 51, 52, 52, 52)	-5.92 (0.98)	-6.95 (0.98)	-8.41 (0.99)	-11.35 (0.98)	-10.41 (0.97)	-1.12 (0.98)
Week 8 (n=51, 51, 51, 52, 52, 50)	-6.27 (0.98)	-8.80 (0.98)	-9.65 (0.99)	-12.89 (0.98)	-12.16 (0.97)	-0.49 (0.99)
Week 12 (n=51, 49, 50, 49, 52, 48)	-7.05 (0.98)	-10.01 (0.99)	-10.08 (1.00)	-13.67 (0.99)	-12.81 (0.97)	-0.67 (1.00)

10. Secondary Outcome

Title	Change From Baseline in Swollen Joint Count (SJC)
Description	Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.
Time Frame	Baseline, Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52)	-3.19 (0.69)	-3.85 (0.68)	-2.58 (0.70)	-6.93 (0.69)	-5.95 (0.68)	-1.58 (0.69)
Week 4 (n=52, 51, 51, 52, 52, 52)	-4.57 (0.69)	-6.10 (0.69)	-6.15 (0.70)	-8.85 (0.69)	-8.15 (0.68)	-1.87 (0.69)
Week 8 (n=51, 51, 51, 52, 52, 50)	-5.25 (0.69)	-7.08 (0.69)	-7.15 (0.70)	-10.04 (0.69)	-10.52 (0.68)	-1.70 (0.70)
Week 12 (n=51, 49, 50, 49, 52, 48)	-5.76 (0.69)	-7.94 (0.70)	-7.75 (0.70)	-10.44 (0.70)	-10.73 (0.68)	-1.29 (0.70)

11. Secondary Outcome

Title	Change From Baseline in Patient's Assessment of Pain
Description	Change from Baseline in Patient's Assessment of Arthritis Pain -VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) was computed as Week 2, 4, 8 or 12 values minus baseline value. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.
Time Frame	Baseline, Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52)	-8.63 (2.94)	-16.70 (2.94)	-19.13 (3.01)	-29.03 (2.97)	-26.45 (2.92)	-1.46 (2.98)
Week 4 (n=52, 51, 51, 52, 52, 52)	-12.97 (2.96)	-21.19 (2.98)	-26.06 (3.01)	-36.65 (2.97)	-35.16 (2.95)	-2.73 (2.98)
Week 8 (n=51, 50, 51, 52, 52, 50)	-17.57 (2.97)	-26.15 (2.99)	-30.37 (3.01)	-41.84 (2.97)	-43.08 (2.95)	1.65 (3.01)
Week 12 (n=51, 49, 50, 49, 52, 48)	-18.38 (2.97)	-22.33 (3.00)	-34.37 (3.02)	-42.91 (3.01)	-43.79 (2.95)	-1.06 (3.03)

12. Secondary Outcome

Title	Change From Baseline in Patient's Global Assessment of Arthritis
Description	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. Change = score at observation minus score at baseline.
Time Frame	Baseline, Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52)	-7.66 (2.96)	-15.25 (2.97)	-20.32 (3.04)	-27.06 (2.99)	-26.80 (2.94)	-1.73 (3.00)
Week 4 (n=52, 51, 51, 52, 52, 52)	-11.22 (2.98)	-23.17 (3.00)	-27.03 (3.04)	-36.64 (2.99)	-35.96 (2.97)	-3.31 (3.00)
Week 8 (n=51, 50, 51, 52, 52, 50)	-16.66 (2.99)	-24.60 (3.01)	-28.78 (3.04)	-41.97 (2.99)	-41.13 (2.97)	0.79 (3.03)
Week 12 (n=51, 49, 50, 49, 52, 48)	-16.29 (2.99)	-20.91 (3.03)	-34.59 (3.05)	-43.55 (3.03)	-41.86 (2.97)	-1.02 (3.05)

13. Secondary Outcome

Title	Change From Baseline in Physician's Global Assessment of Arthritis
Description	Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity; very good and 100 mm = worst disease activity; very poor. Change = score at observation minus score at baseline.
Time Frame	Baseline, Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52)	-13.97 (2.64)	-15.86 (2.63)	-18.10 (2.70)	-31.59 (2.66)	-25.93 (2.61)	-6.09 (2.66)
Week 4 (n=52, 51, 51, 52, 52, 52)	-23.31 (2.65)	-26.22 (2.67)	-30.45 (2.70)	-41.21 (2.66)	-37.07 (2.64)	-9.70 (2.66)
Week 8 (n=51, 51, 51, 52, 52, 50)	-21.99 (2.66)	-32.04 (2.67)	-36.92 (2.70)	-45.98 (2.66)	-44.66 (2.64)	-6.84 (2.69)
Week 12 (n=51, 49, 50, 49, 52, 48)	-25.38 (2.66)	-33.47 (2.69)	-36.89 (2.71)	-49.38 (2.70)	-48.36 (2.64)	-8.35 (2.72)

14. Secondary Outcome

Title	Change From Baseline in C- Reactive Protein (CRP) (mg/L)
Description	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change = value at observation minus value at baseline.
Time Frame	Baseline, Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Least Squares Mean (Standard Error); Unit of Measure: mg/L
Week 2 (n=53, 53, 51, 52, 54, 52)	-5.69 (2.24)	-16.61 (2.24)	-17.32 (2.29)	-22.50 (2.26)	-24.95 (2.22)	1.02 (2.26)
Week 4 (n=52, 51, 51, 52, 52, 52)	-5.56 (2.25)	-16.26 (2.27)	-22.20 (2.29)	-24.47 (2.26)	-24.59 (2.25)	0.59 (2.26)
Week 8 (n=51, 51, 51, 52, 52, 50)	-9.79 (2.27)	-16.71 (2.27)	-23.80 (2.29)	-23.56 (2.26)	-26.03 (2.25)	5.27 (2.29)
Week 12 (n=51, 49, 50, 49, 52, 48)	-8.88 (2.27)	-18.34 (2.30)	-23.97 (2.30)	-25.11 (2.30)	-26.14 (2.25)	8.22 (2.32)

15. Secondary Outcome

Title	Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N)
Description	ACR-N = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The AUC for ACR-N is measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute AUC.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	53	53	52	53	54	52
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	498.47 (341.96)	1876.4 (341.96)	2573.0 (345.23)	3887.4 (341.96)	3628.9 (338.78)	-2415 (345.23)

16. Secondary Outcome

Title	Change From Baseline in Euro Quality of Life (EQ-5D)
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Change = score at Week 12 minus score at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	51	49	50	49	52	48
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	0.10 (0.03)	0.21 (0.03)	0.28 (0.03)	0.33 (0.03)	0.33 (0.03)	-0.04 (0.03)

17. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain
Description	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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	51	49	50	49	52	48
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	2.62 (1.09)	6.23 (1.11)	5.83 (1.13)	9.59 (1.11)	8.61 (1.08)	-2.53 (1.12)

18. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain
Description	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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	51	49	50	49	52	48
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	3.15 (1.18)	4.42 (1.20)	6.17 (1.21)	8.91 (1.20)	7.77 (1.17)	-0.72 (1.22)

19. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain
Description	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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	51	49	50	49	52	48
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	5.94 (1.08)	7.81 (1.10)	9.74 (1.11)	12.58 (1.10)	13.90 (1.07)	0.27 (1.12)

20. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain
Description	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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	51	49	50	49	52	48
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	2.12 (0.84)	4.76 (0.86)	5.37 (0.86)	7.57 (0.86)	7.61 (0.83)	0.16 (0.87)

21. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain
Description	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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change =score at Week 12 minus score at baseline
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg BID	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	51	49	50	49	52	48
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	3.67 (0.74)	6.11 (0.76)	6.58 (0.77)	11.98 (0.77)	9.49 (0.74)	3.38 (0.79)

22. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain
Description	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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	51	49	50	49	52	48
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	2.22 (1.21)	4.88 (1.24)	4.65 (1.24)	4.56 (1.24)	7.62 (1.20)	-0.67 (1.25)

23. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain
Description	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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	51	49	50	49	52	48
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	3.83 (1.41)	4.20 (1.44)	5.64 (1.44)	7.99 (1.44)	6.42 (1.40)	-1.50 (1.47)

24. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain
Description	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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	51	49	50	49	52	48
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	3.29 (1.29)	5.02 (1.32)	8.62 (1.32)	7.64 (1.32)	6.27 (1.28)	0.59 (1.34)

25. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS)
Description	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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	51	49	50	49	52	48
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	3.27 (0.86)	6.03 (0.88)	6.22 (0.89)	10.25 (0.88)	10.27 (0.85)	-1.04 (0.89)

26. Secondary Outcome

Title	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS)
Description	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. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.

Arm/Group Title	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description:	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed	51	49	50	49	52	48
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
	3.00 (1.27)	3.99 (1.30)	7.09 (1.30)	6.15 (1.30)	5.52 (1.26)	0.15 (1.32)

Adverse Events

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). However, what is presented are distinct events. 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 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
Arm/Group Description	Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.	Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
All-Cause Mortality
	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--	--/--	--/--
Serious Adverse Events
	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/53 (0.00%)	3/53 (5.66%)	2/52 (3.85%)	2/53 (3.77%)	1/54 (1.85%)	1/52 (1.92%)
Gastrointestinal disorders
Gastric ulcer perforation †	0/53 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	0/53 (0.00%)	0/54 (0.00%)	0/52 (0.00%)
Infections and infestations
Herpes zoster †	0/53 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	1/53 (1.89%)	0/54 (0.00%)	0/52 (0.00%)
Herpes zoster oticus †	0/53 (0.00%)	0/53 (0.00%)	0/52 (0.00%)	0/53 (0.00%)	1/54 (1.85%)	0/52 (0.00%)
Injury, poisoning and procedural complications
Fibula fracture †	0/53 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	0/53 (0.00%)	0/54 (0.00%)	0/52 (0.00%)
Spinal compression fracture †	0/53 (0.00%)	0/53 (0.00%)	0/52 (0.00%)	0/53 (0.00%)	1/54 (1.85%)	0/52 (0.00%)
Tendon rupture †	0/53 (0.00%)	0/53 (0.00%)	0/52 (0.00%)	1/53 (1.89%)	0/54 (0.00%)	0/52 (0.00%)
Tibia fracture †	0/53 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	0/53 (0.00%)	0/54 (0.00%)	0/52 (0.00%)
Investigations
Alanine aminotransferase increased †	0/53 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	0/53 (0.00%)	0/54 (0.00%)	0/52 (0.00%)
Aspartate aminotransferase increased †	0/53 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	0/53 (0.00%)	0/54 (0.00%)	0/52 (0.00%)
Blood creatine phosphokinase increased †	0/53 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	0/53 (0.00%)	0/54 (0.00%)	0/52 (0.00%)
Nervous system disorders
Post herpetic neuralgia †	0/53 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	0/53 (0.00%)	0/54 (0.00%)	0/52 (0.00%)
Respiratory, thoracic and mediastinal disorders
Atelectasis †	0/53 (0.00%)	0/53 (0.00%)	0/52 (0.00%)	0/53 (0.00%)	0/54 (0.00%)	1/52 (1.92%)
Vascular disorders
Rheumatoid vasculitis †	0/53 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	0/53 (0.00%)	0/54 (0.00%)	0/52 (0.00%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	14/53 (26.42%)	16/53 (30.19%)	19/52 (36.54%)	22/53 (41.51%)	22/54 (40.74%)	16/52 (30.77%)
Gastrointestinal disorders
Abdominal discomfort †	2/53 (3.77%)	1/53 (1.89%)	0/52 (0.00%)	1/53 (1.89%)	0/54 (0.00%)	1/52 (1.92%)
Constipation †	1/53 (1.89%)	0/53 (0.00%)	1/52 (1.92%)	0/53 (0.00%)	3/54 (5.56%)	2/52 (3.85%)
Dental caries †	0/53 (0.00%)	0/53 (0.00%)	2/52 (3.85%)	1/53 (1.89%)	0/54 (0.00%)	1/52 (1.92%)
Diarrhoea †	1/53 (1.89%)	0/53 (0.00%)	0/52 (0.00%)	0/53 (0.00%)	0/54 (0.00%)	2/52 (3.85%)
Gastritis †	0/53 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	0/53 (0.00%)	2/54 (3.70%)	0/52 (0.00%)
Gingivitis †	0/53 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	0/53 (0.00%)	2/54 (3.70%)	1/52 (1.92%)
Stomatitis †	1/53 (1.89%)	1/53 (1.89%)	2/52 (3.85%)	1/53 (1.89%)	0/54 (0.00%)	1/52 (1.92%)
Infections and infestations
Bronchitis	1/53 (1.89%)	1/53 (1.89%)	0/52 (0.00%)	2/53 (3.77%)	0/54 (0.00%)	0/52 (0.00%)
Herpes zoster †	0/53 (0.00%)	0/53 (0.00%)	0/52 (0.00%)	2/53 (3.77%)	1/54 (1.85%)	0/52 (0.00%)
Nasopharyngitis †	6/53 (11.32%)	4/53 (7.55%)	6/52 (11.54%)	3/53 (5.66%)	8/54 (14.81%)	6/52 (11.54%)
Pharyngitis †	0/53 (0.00%)	0/53 (0.00%)	0/52 (0.00%)	3/53 (5.66%)	2/54 (3.70%)	1/52 (1.92%)
Upper respiratory tract infection †	0/53 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	3/53 (5.66%)	0/54 (0.00%)	0/52 (0.00%)
Injury, poisoning and procedural complications
Contusion †	2/53 (3.77%)	1/53 (1.89%)	0/52 (0.00%)	0/53 (0.00%)	1/54 (1.85%)	0/52 (0.00%)
Fall †	3/53 (5.66%)	0/53 (0.00%)	1/52 (1.92%)	1/53 (1.89%)	0/54 (0.00%)	0/52 (0.00%)
Investigations
Alanine aminotransferase increased †	0/53 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	1/53 (1.89%)	1/54 (1.85%)	3/52 (5.77%)
Aspartate aminotransferase increased †	0/53 (0.00%)	0/53 (0.00%)	0/52 (0.00%)	1/53 (1.89%)	0/54 (0.00%)	3/52 (5.77%)
Blood cholesterol increased †	0/53 (0.00%)	1/53 (1.89%)	1/52 (1.92%)	1/53 (1.89%)	2/54 (3.70%)	0/52 (0.00%)
Low density lipoprotein increased †	0/53 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	1/53 (1.89%)	6/54 (11.11%)	0/52 (0.00%)
Metabolism and nutrition disorders
Hypercholesterolaemia †	0/53 (0.00%)	2/53 (3.77%)	0/52 (0.00%)	3/53 (5.66%)	0/54 (0.00%)	0/52 (0.00%)
Hyperlipidaemia †	1/53 (1.89%)	0/53 (0.00%)	2/52 (3.85%)	6/53 (11.32%)	3/54 (5.56%)	0/52 (0.00%)
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis †	0/53 (0.00%)	0/53 (0.00%)	0/52 (0.00%)	0/53 (0.00%)	0/54 (0.00%)	2/52 (3.85%)
Nervous system disorders
Headache †	1/53 (1.89%)	3/53 (5.66%)	2/52 (3.85%)	1/53 (1.89%)	0/54 (0.00%)	1/52 (1.92%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation †	0/53 (0.00%)	0/53 (0.00%)	0/52 (0.00%)	0/53 (0.00%)	0/54 (0.00%)	2/52 (3.85%)
Vascular disorders
Hypertension †	0/53 (0.00%)	0/53 (0.00%)	3/52 (5.77%)	1/53 (1.89%)	0/54 (0.00%)	0/52 (0.00%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

Suzuki M, Shoji S, Miyoshi S, Krishnaswami S. Model-Based Comparison of Dose-Response Profiles of Tofacitinib in Japanese Versus Western Rheumatoid Arthritis Patients. J Clin Pharmacol. 2020 Feb;60(2):198-208. doi: 10.1002/jcph.1514. Epub 2019 Sep 12.

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14. Erratum In: Ann Rheum Dis. 2017 Mar;76(3):611.

Tanaka Y, Takeuchi T, Yamanaka H, Nakamura H, Toyoizumi S, Zwillich S. Efficacy and safety of tofacitinib as monotherapy in Japanese patients with active rheumatoid arthritis: a 12-week, randomized, phase 2 study. Mod Rheumatol. 2015 Jul;25(4):514-21. doi: 10.3109/14397595.2014.995875.

Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00687193
• Other Study ID Numbers: A3921040
• First Submitted: May 22, 2008
• First Posted: May 30, 2008
• Results First Submitted: November 26, 2012
• Results First Posted: December 25, 2012
• Last Update Posted: March 25, 2013