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

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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:
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
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
Hide 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
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Total
Hide 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
Hide 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%
1.Primary Outcome
Title Adjudicated Potential Cardiovascular Events
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
SAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
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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
Hide 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)
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FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
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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
Hide 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
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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
Hide 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
Hide 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
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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
Hide 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
Hide 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
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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
Hide 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
Hide 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
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FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
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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
Hide 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
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FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
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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
Hide 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
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FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
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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
Hide 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
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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
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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
Hide 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
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FAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
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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
Hide 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
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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
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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
Hide 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
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SAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
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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
Hide 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
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SAS
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
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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
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
Hide 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   --/--   --/-- 
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470599     History of Changes
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