A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease

• ClinicalTrials.gov Identifier: NCT01470599
• Recruitment Status: Completed
• First Posted: November 11, 2011
• Results First Posted: October 16, 2017
• Last Update Posted: October 16, 2017
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Crohn's Disease
• Intervention: Drug: CP-690,550
• Enrollment: 150

Participant Flow

Recruitment Details	This study was conducted in participants who completed the 26-week maintenance treatment of Study A3921084 or who withdrew early due to A3921084 study treatment failure according to prespecified criteria.
Pre-assignment Details	Participants were assigned to either the 5 milligram (mg) twice daily (BID) or 10 mg BID treatment group according to clinical remission status as assessed by Crohn's Disease Activity Index (CDAI) score at the end of the A3921084 study treatment visit or early termination visit due to A3921084 study treatment failure.

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Period Title: Overall Study
Started	62	88
Completed	43	45
Not Completed	19	43
Reason Not Completed
Did not meet entrance criteria	1	0
Lost to Follow-up	2	1
Withdrawal by Subject	3	4
Other	1	0
Protocol Violation	3	1
Adverse event related to study drug	2	5
Insufficient clinical response	6	27
Adverse event not related to study drug	1	5

Baseline Characteristics

Arm/Group Title		Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Total
Arm/Group Description		Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		62	88	150
Baseline Analysis Population Description		The safety analysis set (SAS) consisted of all participants enrolled in this open label (OL) extension study who received at least 1 dose of study medication.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	62 participants	88 participants	150 participants
		41.0 (12.6)	38.2 (11.6)	39.4 (12.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	62 participants	88 participants	150 participants
	Female	30 48.4%	41 46.6%	71 47.3%
	Male	32 51.6%	47 53.4%	79 52.7%

Outcome Measures

1. Primary Outcome

Title	Adjudicated Potential Cardiovascular Events
Description	Pre-specified cardiovascular events were adjudicated by committees of external experts who were blinded to treatment assignment. Potential events of interest (pEoI) were identified by the investigator, sponsor, review of alerts from central electrocardiogram assessments, and by search of adverse events (AE)/serious adverse event (SAE) listings for events coded to death (coronary and non-coronary), myocardial infarction (non-fatal), all coronary revascularization, unstable angina, stroke (fatal and non-fatal), transient ischemic attack, congestive heart failure, peripheral arterial vascular disease, dyspnoea, and chest pain. The independent reviewers (IRs) determined if the pEoI met the criteria for EoI classification according to the definitions summarized from the Clinical Data Interchange Standards Consortium 'Standardized Definitions for End Point Events in Cardiovascular Trials' published October 2010.
Time Frame	From baseline to Week 52

Outcome Measure Data

Analysis Population Description

Participants in the SAS who had pEoI and were adjudicated by IRs

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	0	2
Measure Type: Number; Unit of Measure: Number of events meeting criteria
		0

2. Primary Outcome

Title	Adjudicated Malignancy Events
Description	Pre-specified malignancy events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by the investigator, sponsor, potential primary event notifications (i.e. malignancies excluding non-melanoma skin cancers) for a specific protocol, events submitted for histopathology review for potential malignancies which met the criteria for potential malignancies, and by search of AE/SAE listings for events coded to Malignant tumors Standard Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQ) (20000194). IRs determined if the pEoI met the criteria for EoI classification according to the International Classification of Diseases for Oncology, a ten-digit multi-axial classification of the site (4 characters), morphology (4 digits), behavior (1 digit), and grading (1 digit) of neoplasms.
Time Frame	From baseline to Week 52

Outcome Measure Data

Analysis Population Description

Participants in the SAS who had pEoI and were adjudicated by IRs

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	1	1
Measure Type: Number; Unit of Measure: Number of events meeting criteria
	0	1

3. Primary Outcome

Title	Adjudicated Hepatic Injury Events
Description	Pre-specified liver injury events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of clinical, safety & laboratory databases (potential Hy's law event, ALT/AST ≥5 x ULN, events meeting hepatic discontinuation criteria, SAEs coded to MedDRA hepatobiliary system organ class (SOC), AEs/SAEs coded to MedDRA liver infections or infectious biliary disorders SMQ, AEs coded to MedDRA drug-induced liver injury (DILI) preferred term or any death with ALT or AST ≥3xULN, bilirubin ≥2xULN or jaundice). IRs determined if the pEoI met the criteria for EoI classification by assessing DILI (definite, highly likely, probable, possible, unlikely, unrelated or undetermined), pattern (hepatocellular, mixed, cholestatic or undetermined), likely, competing or alternative cause(s), severity (mild, moderate, severe, fatal/transplantation or undetermined), Hy's law case, recovery & liver failure (all yes, no or undetermined).
Time Frame	From baseline to Week 52

Outcome Measure Data

Analysis Population Description

Participants in the SAS who had pEoI and were adjudicated by IRs

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	0	1
Measure Type: Number; Unit of Measure: Number of events meeting criteria
		0

4. Primary Outcome

Title	Adjudicated Opportunistic Infection Events
Description	Pre-specified opportunistic infection events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of SAE listings for serious infections coded to MedDRA infections & infestations SOC &/or events meeting pre-specified criteria for IR pre-screening to determine if adjudication is required. IRs determined if the pEoI met the criteria for EoI classification according to definitions for opportunistic infections (invasive fungal infections per the European Organization for Research & Treatment of Cancer/Invasive Fungal Infections Cooperative Group & the National Institute of Allergy & Infectious Diseases Mycoses Study Group [EORTC/MSG] Consensus Group definitions, endemic fungal infections per the EORTC/MSG Consensus Group definitions, other fungal infections, viral, bacterial & parasitic infections & vaccine dissemination) & special interest infections (actinomycosis, Legionella & mononucleosis-like toxoplasmosis).
Time Frame	From baseline to Week 52

Outcome Measure Data

Analysis Population Description

Participants in the SAS who had pEoI and were adjudicated by IRs

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	4	4
Measure Type: Number; Unit of Measure: Number of events meeting criteria
	1	1

5. Primary Outcome

Title	Adjudicated Gastrointestinal (GI) Perforation Events
Description	Pre-specified GI perforation events were adjudicated by committees of external experts who were blinded to treatment assignment. The pEoI were identified via search of AE/SAE listings using the MedDRA GI Perforation SMQ. The IRs determined if the pEoI met the criteria for EoI classification based on whether a GI perforation occurred and if yes, the location within the GI tract, possible contributing medical conditions and/or concomitant medications.
Time Frame	From baseline to Week 52

Outcome Measure Data

Analysis Population Description

Participants in the SAS who had pEoI and were adjudicated by IRs

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	0	2
Measure Type: Number; Unit of Measure: Number of events meeting criteria
		2

6. Primary Outcome

Title	Adjudicated Interstitial Lung Disease (ILD) Events
Description	Pre-specified ILD events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by searches of the clinical, safety & laboratory databases (AEs coded to the MedDRA ILD SMQ and events nominated by the study clinician or clinical lead). The IRs determined if the pEoI met the criteria for EoI classification by assessment of the ILD event (probably ILD, possible ILD, alternative diagnosis likely, other or insufficient information to classify).
Time Frame	From baseline to Week 52

Outcome Measure Data

Analysis Population Description

Participants in the SAS who had pEoI and were adjudicated by IRs

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

7. Secondary Outcome

Title	Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48
Description	CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of less than (<) 150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95 percent (%) Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) - consisted of all participants enrolled in this OL extension study.

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percent
Clinical remission (n=33, 36)	87.88; (71.80 to 96.60)	55.56; (38.10 to 72.06)
Sustained clinical remission (n=32, 35)	75.00; (56.60 to 88.54)	34.29; (19.13 to 52.21)

8. Secondary Outcome

Title	Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of This Study
Description	CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.
Time Frame	Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up

Outcome Measure Data

Analysis Population Description

Participants in the FAS who met clinical remission criteria at baseline of this study

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	61	4
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Clinical remission: Baseline (n=61, 4)	100.00; (94.13 to 100.00)	100.00; (39.76 to 100.00)
Clinical remission: Week 8 (n=53, 4)	75.47; (61.72 to 86.24)	50.00; (6.76 to 93.24)
Clinical remission: Week 16 (n=52, 4)	84.62; (71.92 to 93.12)	75.00; (19.41 to 99.37)
Clinical remission: Week 24 (n=48, 4)	85.42; (72.24 to 93.93)	25.00; (0.63 to 80.59)
Clinical remission: Week 36 (n=40, 3)	92.50; (79.61 to 98.43)	33.33; (0.84 to 90.57)
Clinical remission: Week 48 (n=32, 3)	87.50; (71.01 to 96.49)	100.00; (29.24 to 100.00)
Clinical remission: Week 52/follow-up (n=37, 3)	64.86; (47.46 to 79.79)	33.33; (0.84 to 90.57)
Sustained clinical remission (n=31, 3)	77.42; (58.90 to 90.41)	33.33; (0.84 to 90.57)

9. Secondary Outcome

Title	Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of This Study
Description	CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. Clinical response was defined as a CDAI score reduction of at least 100 points from the A3921083 study baseline value. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.
Time Frame	Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up

Outcome Measure Data

Analysis Population Description

Participants in the FAS who met clinical response or clinical remission criteria at baseline of this study

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	23
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Clinical remission: Baseline (n=62, 23)	98.39; (91.34 to 99.96)	17.39; (4.95 to 38.78)
Clinical remission: Week 8 (n=54, 20)	75.93; (62.36 to 86.51)	35.00; (15.39 to 59.22)
Clinical remission: Week 16 (n=53, 19)	84.91; (72.41 to 93.25)	36.84; (16.29 to 61.64)
Clinical remission: Week 24 (n=49, 16)	83.67; (70.34 to 92.68)	43.75; (19.75 to 70.12)
Clinical remission: Week 36 (n=41, 13)	90.24; (76.87 to 97.28)	38.46; (13.86 to 68.42)
Clinical remission: Week 48 (n=33, 10)	87.88; (71.80 to 96.60)	50.00; (18.71 to 81.29)
Clinical remission: Week 52/follow-up (n=38, 12)	65.79; (48.65 to 80.37)	41.67; (15.17 to 72.33)
Sustained clinical remission (n=32, 10)	75.00; (56.60 to 88.54)	30.00; (6.67 to 62.25)

10. Secondary Outcome

Title	Time to Relapse Among Participants in Clinical Remission at Baseline
Description	Relapse was defined as an increase in CDAI of more than (>) 100 points from the baseline and an absolute CDAI score of >220 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Data presented are rates estimated from Kaplan-Meier curves. n = number of participants remaining at risk.
Time Frame	From baseline to Week 52

Outcome Measure Data

Analysis Population Description

Participants in the FAS who met clinical remission criteria at baseline of this study

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	61	4
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 8 (n=55, 4)	6.78; (3.38 to 11.78)	NA [1]; (NA to NA)
Week 16 (n=51, 3)	11.86; (7.15 to 17.87)	25.00; (4.56 to 53.66)
Week 24 (n=46, 3)	15.46; (9.98 to 22.05)	25.00; (4.56 to 53.66)
Week 36 (n=38, 3)	21.42; (14.82 to 28.83)	25.00; (4.56 to 53.66)
Week 48 (n=7, 0)	24.69; (17.21 to 32.89)	NA [2]; (NA to NA)

[1]

No participants had a relapse event by Week 8.

[2]

No participants remained at risk of a relapse event by Week 48.

11. Secondary Outcome

Title	Observed CDAI Score by Week
Description	CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants remaining at risk.
Time Frame	Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Mean (Standard Deviation); Unit of Measure: Score on a scale
Baseline (n=62, 88)	77.13 (43.22)	291.19 (95.78)
Week 8 (n=54, 75)	105.39 (75.82)	176.96 (82.39)
Week 16 (n=53, 66)	86.58 (65.23)	178.94 (72.25)
Week 24 (n=49, 59)	85.12 (56.67)	163.66 (79.73)
Week 36 (n=41, 48)	73.34 (59.52)	158.67 (89.15)
Week 48 (n=33, 36)	73.91 (70.23)	154.11 (71.47)
Week 52/Follow-up (n=38, 43)	129.32 (114.82)	180.65 (98.80)

12. Secondary Outcome

Title	Change From Baseline Observed CDAI Score by Week
Description	CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants with non-missing data.
Time Frame	Weeks 8, 16, 24, 36, 48 and 52/follow-up

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Mean (Standard Deviation); Unit of Measure: Score on a scale
Week 8 (n=54, 75)	26.96 (62.68)	-114.31 (112.44)
Week 16 (n=53, 66)	11.72 (52.25)	-112.02 (111.09)
Week 24 (n=49, 59)	6.33 (44.48)	-122.69 (117.65)
Week 36 (n=41, 48)	-10.78 (40.35)	-139.81 (126.18)
Week 48 (n=33, 36)	-4.79 (60.09)	-121.94 (129.21)
Week 52/Follow-up (n=38, 43)	47.66 (109.73)	-107.42 (119.05)

13. Secondary Outcome

Title	Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline
Description	Steroid-free clinical remission at Week 48 was a CDAI <150 points in participants who were steroid-free at Week 48. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Participants in FAS who were on steroids at baseline of this study

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	2	11
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	50.00; (1.26 to 98.74)	9.09; (0.23 to 41.28)

14. Secondary Outcome

Title	Corticosteroid Use Over Time
Description	Use of corticosteroids (yes or no) was recorded at baseline and throughout the study. Percentage of participants taking corticosteriod at each visit was reported.
Time Frame	Weeks 8, 16, 24, 36 and 48

Outcome Measure Data

Analysis Population Description

SAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Measure Type: Number; Unit of Measure: Percentage of participants
Baseline	1.61	20.45
Week 8	4.84	21.59
Week 16	4.84	13.64
Week 24	4.84	12.50
Week 36	3.23	10.23
Week 48	1.61	7.95

15. Secondary Outcome

Title	Percentage of Participants Switching From 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID After Initial Assignment by Visit
Description	There was a single study treatment dose adjustment allowed, at the discretion of the Investigator, from 5 mg BID to 10 mg BID or from 10 mg BID to 5 mg BID, after the initial 8 weeks of fixed open label treatment and for the remaining treatment period of 40 weeks. Percentage of participants whose study treatment were switched from 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID after initial assignment was reported.
Time Frame	From baseline to Week 48

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Measure Type: Number; Unit of Measure: Percentage of participants
Baseline	0	0
Week 8	25.81	0
Week 16	6.45	0
Week 24	3.23	2.27
Week 36	0	1.14
Week 48	0	0

16. Secondary Outcome

Title	Observed Change From Baseline in Fecal Calprotectin by Week
Description	Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. n = number of participants with non-missing data.
Time Frame	Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Mean (Standard Deviation); Unit of Measure: mg per kilogram (mg/kg)
Week 8 (n=53, 71)	-105.51 (436.41)	-102.82 (310.10)
Week 16 (n=54, 64)	-144.65 (423.20)	-35.28 (718.82)
Week 24 (n=49, 55)	-120.49 (511.49)	-130.68 (337.23)
Week 36 (n=41, 42)	-169.92 (354.30)	-133.82 (364.51)
Week 48 (n=37, 38)	-189.61 (462.61)	-123.87 (376.70)
Week 52/Follow-up (n=48, 57)	-51.33 (453.73)	-109.23 (389.54)

17. Secondary Outcome

Title	Observed Change From Baseline in High Sensitivity C-reactive Protein (CRP) by Week
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. n = number of participants with non-missing data.
Time Frame	Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Mean (Standard Deviation); Unit of Measure: mg per liter (mg/L)
Week 8 (n=61, 82)	-0.44 (14.78)	-4.81 (26.76)
Week 16 (n=58, 72)	-2.46 (14.54)	-7.96 (25.11)
Week 24 (n=54, 61)	-2.76 (17.59)	-9.26 (30.20)
Week 36 (n=46, 51)	-4.42 (22.29)	-12.09 (30.61)
Week 48 (n=43, 44)	-4.55 (17.81)	-11.45 (31.30)
Week 52/Follow-up (n=54, 71)	3.86 (21.57)	-4.72 (31.34)

18. Secondary Outcome

Title	Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 48/ET Visit
Description	The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QoL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL. n = number of participants with non-missing data.
Time Frame	Baseline and Week 48/early termination (ET)

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Mean (Standard Deviation); Unit of Measure: Score on a scale
IBDQ Total Score, Baseline (n=62, 87)	187.23 (20.38)	127.32 (34.17)
IBDQ Total Score, Week 48/ET (n=57, 83)	179.26 (29.89)	144.42 (42.16)
Bowel Function Score, Baseline (n=62, 87)	58.56 (6.86)	40.71 (9.90)
Bowel Function Score, Week 48/ET (n=57, 83)	55.70 (9.82)	46.70 (12.38)
Emotional Status Score, Baseline (n=62, 87)	69.68 (8.58)	48.61 (14.42)
Emotional Status Score, Week 48/ET (n=57, 83)	66.98 (12.27)	53.19 (17.32)
Systemic Symptoms Score, Baseline (n=62, 87)	26.95 (5.36)	17.20 (5.55)
Systemic Symptoms Score, Week 48/ET (n=57, 83)	25.82 (6.28)	20.35 (7.07)
Social Function Score, Baseline (n=62, 87)	32.03 (3.59)	20.80 (8.96)
Social Function Score, Week 48/ET (n=57, 83)	30.75 (5.17)	24.18 (8.98)

19. Secondary Outcome

Title	Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/ET Visit
Description	The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL.
Time Frame	Baseline and Week 48/ET

Outcome Measure Data

Analysis Population Description

Participants in the FAS who had non-missing data at Week 48/ET visit

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	57	83
Mean (Standard Deviation); Unit of Measure: Score on a scale
IBDQ Total Score, Week 48/ET	-7.98 (24.93)	18.84 (40.45)
Bowel Function Score, Week 48/ET	-2.72 (8.30)	6.37 (12.41)
Emotional Status Score, Week 48/ET	-3.07 (10.48)	5.36 (15.00)
Systemic Symptoms Score, Week 48/ET	-1.00 (4.83)	3.45 (7.43)
Social Function Score, Week 48/ET	-1.19 (4.24)	3.66 (8.89)

20. Secondary Outcome

Title	Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 48/ET Visit
Description	The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. A score ≥170 corresponds to clinical remission. 95% Clopper-Pearson exact confidence interval reported for the proportions.
Time Frame	Week 48/ET

Outcome Measure Data

Analysis Population Description

Participants in the FAS who had non-missing data at Week 48/ET visit

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	57	83
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	70.18; (56.60 to 81.57)	31.33; (21.59 to 42.44)

21. Secondary Outcome

Title	Percentage of Participants With a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category
Description	The IBD PRTI modified questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to reuse the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.
Time Frame	Week 48/ET visit

Outcome Measure Data

Analysis Population Description

Participants in the FAS who had a response to PRTI assessment at Week 48/ET visit

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	42	46
Measure Type: Number; Unit of Measure: Percentage of participants
PSA: Extremely dissatisfied	0	0
PSA: Dissatisfied	0	8.7
PSA: Neither satisfied nor dissatisfied	0	17.4
PSA: Satisfied	33.3	41.3
PSA: Extremely satisfied	66.7	32.6
PPTA: Injectable prescription medicines	40.5	32.6
PPTA: Prescription medicines taken by mouth	45.2	43.5
PPTA: Surgery	2.4	0
PPTA: Prescription medicines & surgery	7.1	13.0
PPTA: No treatment	4.8	10.9
PPA: Definitely prefer the drug I am receiving now	88.1	56.5
PPA: Slight preference for drug I'm receiving now	4.8	21.7
PPA: I have no preference either way	7.1	17.4
PPA: Slight preference for previous treatment	0	4.3
PPA: No, I definitely prefer my previous treatment	0	0
PWA: Would definitely want to use same drug again	83.3	60.9
PWA: Might want to use the same drug again	14.3	23.9
PWA: I am not sure	2.4	10.9
PWA: Might not want to use same drug again	0	0
PWA: Definitely not want to use same drug again	0	4.3

22. Secondary Outcome

Title	Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit
Description	The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.
Time Frame	Baseline and Week 48/ET visit

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Mean (Standard Deviation); Unit of Measure: Score on a scale
Physical component score, Baseline (n=62, 86)	50.15 (6.73)	37.80 (9.53)
Physical component score, Week 48/ET (n=57, 83)	48.43 (8.22)	41.87 (10.06)
Mental Component Score, Baseline (n=62, 86)	50.25 (9.11)	37.17 (11.94)
Mental Component Score, Week 48/ET (n=57, 83)	48.79 (10.64)	39.60 (12.87)
Physical Functioning Domain, Baseline (n=62, 86)	53.35 (5.50)	43.50 (10.37)
Physical Functioning Domain, Week 48/ET (n=57, 83)	51.40 (8.59)	46.81 (10.22)
Role Physical Domain, Baseline (n=62, 86)	50.97 (8.22)	35.93 (11.30)
Role Physical Domain, Week 48/ET (n=57, 83)	49.38 (8.78)	40.04 (12.99)
Bodily Pain Domain, Baseline (n=62, 87)	51.32 (8.55)	35.31 (9.14)
Bodily Pain Domain, Week 48/ET (n=57, 83)	49.57 (10.30)	41.04 (12.69)
General Health Domain, Baseline (n=62, 87)	41.60 (9.51)	31.74 (8.41)
General Health Domain, Week 48/ET (n=57, 83)	40.39 (10.08)	33.45 (10.16)
Vitality Domain, Baseline (n=62, 87)	52.78 (10.68)	36.92 (9.88)
Vitality Domain, Week 48/ET (n=57, 83)	51.06 (11.38)	41.03 (12.38)
Social Functioning Domain, Baseline (n=62, 87)	51.81 (7.21)	36.38 (12.29)
Social Functioning Domain, Week 48/ET (n=57, 83)	49.42 (9.64)	39.82 (13.39)
Role Emotional Domain, Baseline (n=62, 86)	50.12 (8.85)	38.55 (12.73)
Role Emotional Domain, Week 48/ET (n=57, 83)	47.97 (10.78)	41.13 (13.15)
Mental Health Domain, Baseline (n=62, 87)	49.89 (9.84)	37.61 (11.98)
Mental Health Domain, Week 48/ET (n=57, 83)	49.24 (10.27)	40.13 (12.52)

23. Secondary Outcome

Title	Change From Baseline SF-36 Component and Domain Scores at Week 48/ET Visit
Description	The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.
Time Frame	Baseline and Week 48/ET visit

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Mean (Standard Deviation); Unit of Measure: Score on a scale
Physical component score, Week 48/ET (n=57, 83)	-1.47 (7.17)	4.47 (11.06)
Mental Component Score, Week 48/ET (n=57, 83)	-1.88 (9.05)	3.07 (11.53)
Physical Functioning Domain, Week 48/ET (n=57, 83)	-1.80 (7.50)	3.49 (10.74)
Role Physical Domain, Week 48/ET (n=57, 83)	-1.38 (7.87)	4.60 (12.62)
Bodily Pain Domain, Week 48/ET (n=57, 83)	-1.60 (7.90)	6.15 (12.92)
General Health Domain, Week 48/ET (n=57, 83)	-1.42 (10.00)	2.25 (7.99)
Vitality Domain, Week 48/ET (n=57, 83)	-1.63 (10.39)	4.47 (12.16)
Social Functioning Domain, Week 48/ET (n=57, 83)	-2.92 (9.09)	3.69 (13.46)
Role Emotional Domain, Week 48/ET (n=57, 82)	-2.26 (10.29)	3.28 (11.38)
Mental Health Domain, Week 48/ET (n=57, 83)	-1.02 (8.63)	2.87 (11.72)

24. Secondary Outcome

Title	EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit
Description	EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 from 0.594 to 1.000; a higher score indicates a better health state. n = number of participants with non-missing data.
Time Frame	Baseline and Week 48/ET visit

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Mean (Standard Deviation); Unit of Measure: Score on a scale
Utility Score, Baseline (n=62, 85)	0.85 (0.21)	0.57 (0.28)
Utility Score, Week 48/ET (n=57, 83)	0.84 (0.16)	0.66 (0.31)

25. Secondary Outcome

Title	Change From Baseline EQ-5D Utility Scores at Week 48/ET Visit
Description	EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 from 0.594 to 1.000; a higher score indicates a better health state.
Time Frame	Baseline and Week 48/ET visit

Outcome Measure Data

Analysis Population Description

Participants in the FAS who had non-missing data at Week 48/ET visit

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	57	83
Mean (Standard Deviation); Unit of Measure: Score on a scale
	-0.02 (0.21)	0.10 (0.36)

26. Secondary Outcome

Title	EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit
Description	EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. n = number of participants with non-missing data.
Time Frame	Baseline and Week 48/ET visit

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Mean (Standard Deviation); Unit of Measure: mm
VAS Score, Baseline (n=62, 86)	77.98 (16.18)	48.60 (19.21)
VAS Score, Week 48/ET (n=57, 83)	73.40 (18.54)	57.60 (24.60)

27. Secondary Outcome

Title	Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit
Description	EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time Frame	Baseline and Week 48/ET visit

Outcome Measure Data

Analysis Population Description

Participants in the FAS who had non-missing data at Week 48/ET visit

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	57	83
Mean (Standard Deviation); Unit of Measure: mm
	-3.79 (20.56)	10.16 (26.57)

28. Secondary Outcome

Title	Percentage of Participants Hospitalized Due to Crohn's Disease
Description	The number of participants hospitalized due to Crohn's disease were recorded at every study visit.
Time Frame	From baseline to Week 52/follow-up

Outcome Measure Data

Analysis Population Description

SAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Measure Type: Number; Unit of Measure: Percentage of participants
	11.3	15.9

29. Secondary Outcome

Title	Length of Hospitalizations Due to Crohn's Disease
Description	The length of hospitalizations due to Crohn's disease were recorded at every study visit.
Time Frame	From baseline to Week 52/follow-up

Outcome Measure Data

Analysis Population Description

SAS

Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description:	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Overall Number of Participants Analyzed	62	88
Measure Type: Number; Unit of Measure: Percentage of participnats
<3 days	1.6	2.3
3 to 6 days	6.5	10.2
7 to 10 days	0	3.4
> 10 days	0	3.4

Adverse Events

Time Frame	SAEs were assessed from informed consent through and including 28 calendar days after last administration of study treatment. Non-SAEs were recorded from time of first dose of study treatment through last participant visit.
Adverse Event Reporting Description	The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
Arm/Group Description	Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.	Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
All-Cause Mortality
	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
	Affected / at Risk (%)	Affected / at Risk (%)
Total	5/62 (8.06%)	14/88 (15.91%)
Gastrointestinal disorders
Colon dysplasia * 1	1/62 (1.61%)	0/88 (0.00%)
Crohn's disease * 1	3/62 (4.84%)	7/88 (7.95%)
Small intestinal obstruction * 1	0/62 (0.00%)	2/88 (2.27%)
General disorders
Chest pain * 1	1/62 (1.61%)	0/88 (0.00%)
Influenza like illness * 1	1/62 (1.61%)	0/88 (0.00%)
Pyrexia * 1	0/62 (0.00%)	1/88 (1.14%)
Hepatobiliary disorders
Biliary colic * 1	0/62 (0.00%)	1/88 (1.14%)
Immune system disorders
Hypersensitivity * 1	0/62 (0.00%)	1/88 (1.14%)
Infections and infestations
Anal abscess * 1	0/62 (0.00%)	1/88 (1.14%)
Diarrhoea infectious * 1	1/62 (1.61%)	0/88 (0.00%)
Pyelonephritis * 1	1/62 (1.61%)	0/88 (0.00%)
Vulval abscess * 1	0/62 (0.00%)	1/88 (1.14%)
Injury, poisoning and procedural complications
Incisional hernia * 1	0/62 (0.00%)	1/88 (1.14%)
Investigations
C-reactive protein increased * 1	0/62 (0.00%)	1/88 (1.14%)
Renal and urinary disorders
Acute kidney injury * 1	1/62 (1.61%)	0/88 (0.00%)
Reproductive system and breast disorders
Perineal fistula * 1	0/62 (0.00%)	1/88 (1.14%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea * 1	1/62 (1.61%)	0/88 (0.00%)
Skin and subcutaneous tissue disorders
Hyperhidrosis * 1	1/62 (1.61%)	0/88 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA version 19.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID
	Affected / at Risk (%)	Affected / at Risk (%)
Total	42/62 (67.74%)	58/88 (65.91%)
Blood and lymphatic system disorders
Anaemia * 1	3/62 (4.84%)	4/88 (4.55%)
Ear and labyrinth disorders
Vertigo * 1	0/62 (0.00%)	2/88 (2.27%)
Gastrointestinal disorders
Abdominal distension * 1	2/62 (3.23%)	3/88 (3.41%)
Abdominal pain * 1	7/62 (11.29%)	7/88 (7.95%)
Abdominal pain upper * 1	1/62 (1.61%)	2/88 (2.27%)
Anal fissure * 1	1/62 (1.61%)	2/88 (2.27%)
Aphthous ulcer * 1	1/62 (1.61%)	3/88 (3.41%)
Constipation * 1	2/62 (3.23%)	1/88 (1.14%)
Crohn's disease * 1	19/62 (30.65%)	11/88 (12.50%)
Diarrhoea * 1	3/62 (4.84%)	1/88 (1.14%)
Dyspepsia * 1	0/62 (0.00%)	3/88 (3.41%)
Flatulence * 1	0/62 (0.00%)	2/88 (2.27%)
Food poisoning * 1	2/62 (3.23%)	0/88 (0.00%)
Haematochezia * 1	1/62 (1.61%)	2/88 (2.27%)
Haemorrhoids * 1	0/62 (0.00%)	4/88 (4.55%)
Nausea * 1	2/62 (3.23%)	9/88 (10.23%)
Proctalgia * 1	1/62 (1.61%)	2/88 (2.27%)
Toothache * 1	3/62 (4.84%)	0/88 (0.00%)
Vomiting * 1	1/62 (1.61%)	6/88 (6.82%)
General disorders
Chest pain * 1	2/62 (3.23%)	2/88 (2.27%)
Cyst * 1	2/62 (3.23%)	0/88 (0.00%)
Fatigue * 1	1/62 (1.61%)	4/88 (4.55%)
Pyrexia * 1	1/62 (1.61%)	6/88 (6.82%)
Infections and infestations
Bartholin's abscess * 1	0/30 (0.00%)	1/41 (2.44%)
Bartholinitis * 1	0/30 (0.00%)	2/41 (4.88%)
Cystitis * 1	2/62 (3.23%)	0/88 (0.00%)
Folliculitis * 1	0/62 (0.00%)	2/88 (2.27%)
Gastroenteritis * 1	7/62 (11.29%)	2/88 (2.27%)
Herpes zoster * 1	1/62 (1.61%)	2/88 (2.27%)
influenza * 1	5/62 (8.06%)	8/88 (9.09%)
Nasopharyngitis * 1	8/62 (12.90%)	7/88 (7.95%)
Oral herpes * 1	3/62 (4.84%)	0/88 (0.00%)
Pharyngitis * 1	2/62 (3.23%)	0/88 (0.00%)
Upper respiratory tract infection * 1	2/62 (3.23%)	2/88 (2.27%)
Urinary tract infection * 1	8/62 (12.90%)	7/88 (7.95%)
Vaginal infection * 1	1/30 (3.33%)	0/41 (0.00%)
Vaginitis bacterial * 1	0/30 (0.00%)	1/41 (2.44%)
Vulvovaginal candidiasis * 1	0/30 (0.00%)	1/41 (2.44%)
Vulvovaginal mycotic infection * 1	0/30 (0.00%)	2/41 (4.88%)
Investigations
Blood alkaline phosphatase increased * 1	2/62 (3.23%)	0/88 (0.00%)
Blood creatine phosphokinase increased * 1	3/62 (4.84%)	5/88 (5.68%)
C-reactive protein increased * 1	2/62 (3.23%)	0/88 (0.00%)
Gamma-glutamyltransferase increased * 1	2/62 (3.23%)	0/88 (0.00%)
Lymphocyte count decreased * 1	1/62 (1.61%)	2/88 (2.27%)
Smear cervix abnormal * 1	1/30 (3.33%)	0/41 (0.00%)
Weight decreased * 1	2/62 (3.23%)	1/88 (1.14%)
Metabolism and nutrition disorders
Dehydration * 1	0/62 (0.00%)	2/88 (2.27%)
Hypercholesterolaemia * 1	0/62 (0.00%)	2/88 (2.27%)
Vitamin B12 deficiency * 1	0/62 (0.00%)	2/88 (2.27%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	5/62 (8.06%)	8/88 (9.09%)
Back pain * 1	1/62 (1.61%)	4/88 (4.55%)
Muscle spasms * 1	2/62 (3.23%)	2/88 (2.27%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon * 1	0/62 (0.00%)	2/88 (2.27%)
Nervous system disorders
Headache * 1	1/62 (1.61%)	2/88 (2.27%)
Psychiatric disorders
Anxiety * 1	0/62 (0.00%)	3/88 (3.41%)
Insomnia * 1	2/62 (3.23%)	0/88 (0.00%)
Reproductive system and breast disorders
Amenorrhoea * 1	0/30 (0.00%)	1/41 (2.44%)
Balanoposthitis * 1	1/32 (3.13%)	0/47 (0.00%)
Erectile dusfunction * 1	1/32 (3.13%)	0/47 (0.00%)
Oligomenorrhoea * 1	0/30 (0.00%)	1/41 (2.44%)
Testicular swelling * 1	0/32 (0.00%)	1/47 (2.13%)
Vulvovaginal pruritus * 1	0/30 (0.00%)	1/41 (2.44%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	1/62 (1.61%)	2/88 (2.27%)
Skin and subcutaneous tissue disorders
Dermatitis * 1	0/62 (0.00%)	2/88 (2.27%)
Rash * 1	1/62 (1.61%)	2/88 (2.27%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA version 19.0

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.

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):

Panes J, D'Haens GR, Higgins PDR, Mele L, Moscariello M, Chan G, Wang W, Niezychowski W, Su C, Maller E. Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study. Aliment Pharmacol Ther. 2019 Feb;49(3):265-276. doi: 10.1111/apt.15072.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01470599
• Other Study ID Numbers: A3921086; 2011-003622-27 ( EudraCT Number )
• First Submitted: October 27, 2011
• First Posted: November 11, 2011
• Results First Submitted: June 20, 2017
• Results First Posted: October 16, 2017
• Last Update Posted: October 16, 2017