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Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis (OCTAVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01470612
Recruitment Status : Completed
First Posted : November 11, 2011
Results First Posted : September 17, 2021
Last Update Posted : September 17, 2021
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 Ulcerative Colitis
Intervention Drug: CP-690,550
Enrollment 944
Recruitment Details Participants enrolled in this Study A3921139: 1) who had completed or had early withdrawal due to treatment failure in Study A3921096 (NCT01458574) 2) or who were non-responders after completing induction studies A3921094 (NCT01465763) or A3921095 (NCT01458951). Eligible participants assigned to either Tofacitinib 5 mg BID or 10 mg BID depending if participant was in remission at baseline of A3921139. Remission=total Mayo score <=2 with no individual sub score >1, rectal bleeding sub score =0.
Pre-assignment Details Treatment failure for Study A3921096 was an increase in Mayo score of >=3 points from baseline value, with an increase in rectal bleeding sub score by >=1 point, and an increase of endoscopic sub score of >=1 point after a minimum of 8 weeks treatment. If endoscopic sub score and baseline endoscopic sub score was 3 (maximum value), then an increase by >=1 point was not needed for treatment failure. But all other components of the treatment failure criteria were needed to be met.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139. Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Period Title: Overall Study
Started 175 769
Completed 91 104
Not Completed 84 665
Reason Not Completed
Adverse Event             20             80
Death             0             1
Lack of Efficacy             20             326
Lost to Follow-up             2             5
Did not meet entrance criteria             0             1
Pregnancy             2             10
Protocol Violation             2             7
Withdrawal by Subject             24             79
Other             14             156
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID Total
Hide Arm/Group Description Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139. Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139. Total of all reporting groups
Overall Number of Baseline Participants 175 769 944
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants who received at least 1 dose of study medication in this study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 175 participants 769 participants 944 participants
44.5  (14.6) 40.5  (13.5) 41.2  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 769 participants 944 participants
Female
79
  45.1%
310
  40.3%
389
  41.2%
Male
96
  54.9%
459
  59.7%
555
  58.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 769 participants 944 participants
White
136
  77.7%
615
  80.0%
751
  79.6%
Black
0
   0.0%
9
   1.2%
9
   1.0%
Asian
25
  14.3%
97
  12.6%
122
  12.9%
Other
9
   5.1%
24
   3.1%
33
   3.5%
Unspecified
5
   2.9%
24
   3.1%
29
   3.1%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.
Time Frame Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAS) included all participants who received at least 1 dose of study medication in this study.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 175 769
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with AEs
154
  88.0%
626
  81.4%
Participants with SAEs
39
  22.3%
147
  19.1%
2.Primary Outcome
Title Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs)
Hide Description Serious infections were treated infections that required parenteral antimicrobial therapy or hospitalization for treatment or; met other criteria that required the infection to be classified as a serious adverse event (SAE). SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least 1 dose of study medication in this study.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 175 769
Measure Type: Count of Participants
Unit of Measure: Participants
8
   4.6%
31
   4.0%
3.Primary Outcome
Title Number of Participants With Laboratory Test Abnormalities
Hide Description Laboratory abnormalities: Hemoglobin, hematocrit, RBC: <0.8* LLN; reticulocytes (absolute [Abs], %): <0.5* LLN, >1.5* ULN; MCV, MCH: <0.9* LLN, >1.1* ULN; platelets:<0.5* LLN, >1.75* ULN; WBC:<0.6* LLN,>1.5* ULN; lymphocytes (Abs, %), total neutrophils (Abs,%):<0.8* LLN, >1.2* ULN; Basophils (Abs,%),eosinophils(Abs, %),monocytes(Abs, %):>1.2* ULN; total bilirubin,direct bilirubin,indirect bilirubin:>1.5* ULN; AST,ALT,gamma GT, LDH,ALP: >3.0* ULN; total protein,albumin: <0.8* LLN,>1.2* ULN: BUN,creatinine: >1.3* ULN;uric acid:>1.2* ULN; cholesterol,triglycerides: >1.3* ULN; cholesterol (HDL: <0.8* LLN; LDL: >1.2* ULN); sodium: <0.95* LLN, >1.05* ULN; potassium, chloride, calcium, bicarbonate: <0.9* LLN, >1.1* ULN; glucose: <0.6* LLN; creatine kinase >2.0* ULN; urine specific gravity: <1.003; urine pH: <4.5; urine (glucose,protein,blood,nitrite,leukocyte,esterase): >=1; Urine (RBC,WBC): >=20; urine epithelial cells:>=6; urine (casts,granular casts,hyaline casts): >1; urine bacteria:>20.
Time Frame Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 175 761
Measure Type: Count of Participants
Unit of Measure: Participants
162
  92.6%
670
  88.0%
4.Primary Outcome
Title Number of Participants With Vital Sign Abnormalities
Hide Description Vital sign abnormalities included greater than or equal to (>=) 30 millimeter of mercury [mmHg] increase in systolic blood pressure (BP), >=30 mmHg decrease in systolic BP, Systolic BP (less than [<] 90 mmHg), >=20 mmHg increase in diastolic BP, >=20 mmHg decrease in diastolic BP, diastolic BP (<50 mmHg), pulse rate (<40 beats per minute [BPM]), pulse rate (greater than [>] 120 BPM).
Time Frame Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at each specified category.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 175 763
Measure Type: Count of Participants
Unit of Measure: Participants
Systolic BP (>=30 mmHg increase) Number Analyzed 172 participants 748 participants
20
  11.6%
113
  15.1%
Systolic BP (>=30 mmHg decrease) Number Analyzed 172 participants 748 participants
19
  11.0%
44
   5.9%
Systolic BP (<90 mmHg) Number Analyzed 175 participants 763 participants
3
   1.7%
13
   1.7%
Diastolic BP (>=20 mmHg increase) Number Analyzed 172 participants 748 participants
21
  12.2%
137
  18.3%
Diastolic BP (>=20 mmHg decrease) Number Analyzed 172 participants 748 participants
37
  21.5%
78
  10.4%
Diastolic BP (<50 mmHg) Number Analyzed 175 participants 763 participants
3
   1.7%
16
   2.1%
Pulse Rate (<40 BPM) Number Analyzed 175 participants 763 participants
1
   0.6%
0
   0.0%
Pulse Rate (>120 BPM) Number Analyzed 175 participants 763 participants
0
   0.0%
8
   1.0%
5.Primary Outcome
Title Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline
Hide Description Physical examinations included weight, general appearance, head, ears, eyes, nose, mouth, throat, thyroid, skin (presence of rash), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), perianal, musculoskeletal, extremities, neurologic (mental status, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Clinically significant changes were judged by the investigator.
Time Frame Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least 1 dose of study medication in this study.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 175 769
Measure Type: Count of Participants
Unit of Measure: Participants
84
  48.0%
391
  50.8%
6.Primary Outcome
Title Number of Participants With Electrocardiogram (ECG) Abnormalities
Hide Description ECG abnormalities criteria: maximum PR interval (>=300 millisecond); maximum QRS complex (>=200 millisecond); and maximum QT interval (>=500 millisecond).
Time Frame Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at each specified category.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 158 707
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum PR interval (>=300) Number Analyzed 157 participants 706 participants
0
   0.0%
0
   0.0%
Maximum QRS complex (>=200) Number Analyzed 158 participants 707 participants
0
   0.0%
0
   0.0%
Maximum QT interval (>=500) Number Analyzed 158 participants 707 participants
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events
Hide Description Incidence rates for adjudicated cardiovascular (major adverse cardiovascular event [MACE]), malignancy (non-melanoma skin cancer [NMSC], malignancies excluding NMSC, opportunistic infections (OIs) (both herpes zoster and non herpes zoster OIs) and thromboembolic (venous thromboembolism) safety events were analyzed. This outcome measure was measured in participants with events per 100 participants-years (pt with events/100 pts-yrs).
Time Frame Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least 1 dose of study medication in this study.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 175 769
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: pt with events/100 pts-yrs
Major adverse cardiovascular event (MACE)
0.31
(0.04 to 1.13)
0.11
(0.01 to 0.40)
Nonmelanoma skin cancer (NMSC)
0.96
(0.35 to 2.08)
0.68
(0.35 to 1.19)
Malignancies excluding NMSC
1.09
(0.44 to 2.25)
1.00
(0.60 to 1.59)
Herpes Zoster OI
0.47
(0.10 to 1.37)
0.79
(0.43 to 1.32)
Non Herpes Zoster OIs
0.16
(0.00 to 0.87)
0.17
(0.03 to 0.49)
Venous thromboembolism
0.00
(0.00 to 0.57)
0.33
(0.12 to 0.73)
8.Secondary Outcome
Title Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases
Hide Description Remission in participants was defined as a total Mayo score of less than or equals to (<=) 2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Time Frame Months 2, 12, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at each specified time point. Data is presented for observed cases, no imputation technique was applied.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 164 676
Measure Type: Count of Participants
Unit of Measure: Participants
Month 2 Number Analyzed 164 participants 676 participants
131
  79.9%
188
  27.8%
Month 12 Number Analyzed 154 participants 447 participants
129
  83.8%
279
  62.4%
Month 24 Number Analyzed 132 participants 371 participants
103
  78.0%
264
  71.2%
Month 36 Number Analyzed 113 participants 299 participants
98
  86.7%
239
  79.9%
9.Secondary Outcome
Title Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Hide Description Remission in participants was defined as a total Mayo score of <=2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Time Frame Months 2, 12, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication in this study. NRI method was used for missing data except for visits after a participant advanced to other studies where LOCF method was used.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 175 769
Measure Type: Count of Participants
Unit of Measure: Participants
Month 2
131
  74.9%
188
  24.4%
Month 12
129
  73.7%
279
  36.3%
Month 24
103
  58.9%
264
  34.3%
Month 36
103
  58.9%
259
  33.7%
10.Secondary Outcome
Title Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases
Hide Description Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Time Frame Months 2, 12, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at each specified time point. Data is presented for observed cases, no imputation technique was applied.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 164 676
Measure Type: Count of Participants
Unit of Measure: Participants
Month 2 Number Analyzed 164 participants 676 participants
132
  80.5%
191
  28.3%
Month 12 Number Analyzed 154 participants 447 participants
129
  83.8%
282
  63.1%
Month 24 Number Analyzed 132 participants 371 participants
104
  78.8%
266
  71.7%
Month 36 Number Analyzed 113 participants 299 participants
102
  90.3%
240
  80.3%
11.Secondary Outcome
Title Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Hide Description Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Time Frame Months 2, 12, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication in this study. NRI method was used for missing data except for visits after a participant advanced to other studies where LOCF method was used.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 175 769
Measure Type: Count of Participants
Unit of Measure: Participants
Month 2
132
  75.4%
191
  24.8%
Month 12
129
  73.7%
282
  36.7%
Month 24
104
  59.4%
266
  34.6%
Month 36
107
  61.1%
260
  33.8%
12.Secondary Outcome
Title Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases
Hide Description PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.
Time Frame Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at each specified time point. Data is presented for observed cases, no imputation technique was applied.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 166 729
Measure Type: Count of Participants
Unit of Measure: Participants
Month 1 Number Analyzed 166 participants 729 participants
158
  95.2%
275
  37.7%
Month 4 Number Analyzed 165 participants 532 participants
152
  92.1%
375
  70.5%
Month 6 Number Analyzed 166 participants 505 participants
155
  93.4%
395
  78.2%
Month 9 Number Analyzed 160 participants 469 participants
154
  96.3%
390
  83.2%
Month 15 Number Analyzed 145 participants 418 participants
139
  95.9%
361
  86.4%
Month 18 Number Analyzed 144 participants 404 participants
137
  95.1%
354
  87.6%
Month 21 Number Analyzed 138 participants 394 participants
125
  90.6%
351
  89.1%
Month 27 Number Analyzed 125 participants 348 participants
117
  93.6%
319
  91.7%
Month 30 Number Analyzed 124 participants 338 participants
117
  94.4%
307
  90.8%
Month 33 Number Analyzed 118 participants 326 participants
111
  94.1%
304
  93.3%
Month 39 Number Analyzed 105 participants 281 participants
102
  97.1%
261
  92.9%
Month 42 Number Analyzed 100 participants 253 participants
95
  95.0%
236
  93.3%
Month 45 Number Analyzed 102 participants 226 participants
95
  93.1%
212
  93.8%
Month 48 Number Analyzed 92 participants 199 participants
87
  94.6%
183
  92.0%
Month 51 Number Analyzed 89 participants 175 participants
87
  97.8%
162
  92.6%
Month 54 Number Analyzed 71 participants 147 participants
68
  95.8%
140
  95.2%
Month 57 Number Analyzed 56 participants 128 participants
54
  96.4%
120
  93.8%
Month 60 Number Analyzed 39 participants 107 participants
38
  97.4%
98
  91.6%
Month 63 Number Analyzed 28 participants 89 participants
28
 100.0%
80
  89.9%
Month 66 Number Analyzed 21 participants 73 participants
19
  90.5%
67
  91.8%
Month 69 Number Analyzed 11 participants 54 participants
10
  90.9%
49
  90.7%
Month 72 Number Analyzed 6 participants 44 participants
6
 100.0%
40
  90.9%
Month 75 Number Analyzed 3 participants 26 participants
3
 100.0%
24
  92.3%
Month 78 Number Analyzed 4 participants 19 participants
4
 100.0%
18
  94.7%
Month 81 Number Analyzed 0 participants 11 participants
10
  90.9%
Month 84 Number Analyzed 0 participants 8 participants
6
  75.0%
13.Secondary Outcome
Title Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Hide Description PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total PMS score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.
Time Frame Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication in this study. Here, "Number analyzed" signifies participants evaluable at each specified time point. NRI method was used for missing data at all visits except for visits after a participant advanced to other studies and would reach the visits if the participant stayed in the study where LOCF method was used.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 175 769
Measure Type: Count of Participants
Unit of Measure: Participants
Month 1 Number Analyzed 175 participants 769 participants
158
  90.3%
275
  35.8%
Month 4 Number Analyzed 175 participants 769 participants
152
  86.9%
375
  48.8%
Month 6 Number Analyzed 175 participants 769 participants
155
  88.6%
395
  51.4%
Month 9 Number Analyzed 175 participants 769 participants
154
  88.0%
390
  50.7%
Month 15 Number Analyzed 175 participants 769 participants
139
  79.4%
361
  46.9%
Month 18 Number Analyzed 175 participants 769 participants
137
  78.3%
354
  46.0%
Month 21 Number Analyzed 175 participants 769 participants
125
  71.4%
351
  45.6%
Month 27 Number Analyzed 175 participants 769 participants
117
  66.9%
325
  42.3%
Month 30 Number Analyzed 175 participants 769 participants
117
  66.9%
316
  41.1%
Month 33 Number Analyzed 175 participants 769 participants
114
  65.1%
317
  41.2%
Month 39 Number Analyzed 175 participants 769 participants
108
  61.7%
293
  38.1%
Month 42 Number Analyzed 175 participants 769 participants
102
  58.3%
286
  37.2%
Month 45 Number Analyzed 175 participants 769 participants
102
  58.3%
283
  36.8%
Month 48 Number Analyzed 175 participants 769 participants
95
  54.3%
274
  35.6%
Month 51 Number Analyzed 175 participants 769 participants
96
  54.9%
267
  34.7%
Month 54 Number Analyzed 170 participants 764 participants
76
  44.7%
250
  32.7%
Month 57 Number Analyzed 160 participants 753 participants
61
  38.1%
234
  31.1%
Month 60 Number Analyzed 149 participants 732 participants
44
  29.5%
213
  29.1%
Month 63 Number Analyzed 135 participants 707 participants
31
  23.0%
194
  27.4%
Month 66 Number Analyzed 125 participants 659 participants
22
  17.6%
168
  25.5%
Month 69 Number Analyzed 114 participants 562 participants
13
  11.4%
131
  23.3%
Month 72 Number Analyzed 109 participants 468 participants
7
   6.4%
102
  21.8%
Month 75 Number Analyzed 102 participants 412 participants
3
   2.9%
73
  17.7%
Month 78 Number Analyzed 96 participants 339 participants
4
   4.2%
52
  15.3%
Month 81 Number Analyzed 95 participants 284 participants
0
   0.0%
29
  10.2%
Month 84 Number Analyzed 91 participants 210 participants
0
   0.0%
15
   7.1%
14.Secondary Outcome
Title Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases
Hide Description Mucosal healing in participants was defined as Mayo endoscopic sub score of 0 or 1. The Mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicated higher disease severity.
Time Frame Months 2, 12, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at each specified time point. Data is presented for observed cases, no imputation technique was applied.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 169 690
Measure Type: Count of Participants
Unit of Measure: Participants
Month 2 Number Analyzed 169 participants 690 participants
152
  89.9%
279
  40.4%
Month 12 Number Analyzed 156 participants 458 participants
140
  89.7%
340
  74.2%
Month 24 Number Analyzed 136 participants 382 participants
119
  87.5%
307
  80.4%
Month 36 Number Analyzed 115 participants 307 participants
107
  93.0%
265
  86.3%
15.Secondary Outcome
Title Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Hide Description Mucosal healing in participants was defined as mayo endoscopic sub score of 0 or 1. The mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicating higher disease severity.
Time Frame Months 2, 12, 24 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication in this study. NRI method was used for missing data at all visits and LOCF method was used for visits after a participant advanced to next study.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 175 769
Measure Type: Count of Participants
Unit of Measure: Participants
Month 2
152
  86.9%
279
  36.3%
Month 12
140
  80.0%
340
  44.2%
Month 24
119
  68.0%
307
  39.9%
Month 36
113
  64.6%
285
  37.1%
16.Secondary Outcome
Title Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Hide Description IBDQ was a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease-specific quality of life in participants with inflammatory bowel disease (IBD), including ulcerative colitis consisted of 32 items scored from 1 (worst response) to 7 (best response). For each domain, higher score indicates better quality of life (QOL). Total IBDQ score was the sum of each item score, and ranged from 32 to 224 with a higher score indicated better QOL.
Time Frame Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication in this study. Here, "Number analyzed" signifies participants evaluable at each specified time point. NRI method was used for missing data at all visits except for visits after a participant advanced to other studies and would reach the visits if the participant stayed in the study where LOCF method was used.
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description:
Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139.
Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
Overall Number of Participants Analyzed 175 769
Measure Type: Count of Participants
Unit of Measure: Participants
Month 2 Number Analyzed 175 participants 769 participants
154
  88.0%
419
  54.5%
Month 6 Number Analyzed 175 participants 769 participants
151
  86.3%
395
  51.4%
Month 12 Number Analyzed 175 participants 769 participants
140
  80.0%
365
  47.5%
Month 18 Number Analyzed 175 participants 769 participants
123
  70.3%
354
  46.0%
Month 24 Number Analyzed 175 participants 769 participants
120
  68.6%
315
  41.0%
Month 30 Number Analyzed 175 participants 769 participants
115
  65.7%
299
  38.9%
Month 36 Number Analyzed 175 participants 769 participants
111
  63.4%
294
  38.2%
Month 48 Number Analyzed 175 participants 769 participants
93
  53.1%
265
  34.5%
Month 60 Number Analyzed 149 participants 732 participants
45
  30.2%
215
  29.4%
Month 72 Number Analyzed 109 participants 468 participants
8
   7.3%
99
  21.2%
Month 84 Number Analyzed 91 participants 210 participants
0
   0.0%
14
   6.7%
Time Frame Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Adverse Event Reporting Description Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
 
Arm/Group Title Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Hide Arm/Group Description Participants who completed Study A3921096 and were in remission at Week 52 of Study A3921096, received Tofacitinib 5 milligram (mg) tablets twice daily (BID) for maximum of 80 months in this Study A3921139. Participants who had completed Study A3921096 and not in remission, or who had early withdrawal due to treatment failure from Study A3921096, or who were non responders after completing A3921094 or A3921095 received Tofacitinib 10 mg tablets twice daily for maximum of 84 months in this Study A3921139.
All-Cause Mortality
Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   0/175 (0.00%)   6/769 (0.78%) 
Hide Serious Adverse Events
Tofacitinib 5 mg BID Tofacitinib 10 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   39/175 (22.29%)   147/769 (19.12%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/175 (0.00%)  2/769 (0.26%) 
Cardiac disorders     
Acute myocardial infarction * 1  1/175 (0.57%)  0/769 (0.00%) 
Angina pectoris * 1  1/175 (0.57%)  2/769 (0.26%) 
Atrial fibrillation * 1  1/175 (0.57%)  0/769 (0.00%) 
Atrioventricular block second degree * 1  0/175 (0.00%)  1/769 (0.13%) 
Cardiac arrest * 1  0/175 (0.00%)  1/769 (0.13%) 
Cardiac failure * 1  1/175 (0.57%)  0/769 (0.00%) 
Coronary artery disease * 1  0/175 (0.00%)  1/769 (0.13%) 
Myocarditis * 1  1/175 (0.57%)  0/769 (0.00%) 
Pericarditis * 1  0/175 (0.00%)  1/769 (0.13%) 
Congenital, familial and genetic disorders     
Hydrocele * 1  0/175 (0.00%)  1/769 (0.13%) 
Ear and labyrinth disorders     
Deafness unilateral * 1  0/175 (0.00%)  1/769 (0.13%) 
Vertigo * 1  0/175 (0.00%)  2/769 (0.26%) 
Endocrine disorders     
Hyperparathyroidism * 1  0/175 (0.00%)  1/769 (0.13%) 
Thyroid mass * 1  0/175 (0.00%)  1/769 (0.13%) 
Eye disorders     
Cataract * 1  0/175 (0.00%)  1/769 (0.13%) 
Diplopia * 1  0/175 (0.00%)  1/769 (0.13%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/175 (0.00%)  2/769 (0.26%) 
Abdominal pain lower * 1  0/175 (0.00%)  1/769 (0.13%) 
Anal fistula * 1  0/175 (0.00%)  1/769 (0.13%) 
Anal skin tags * 1  0/175 (0.00%)  1/769 (0.13%) 
Colitis ulcerative * 1  4/175 (2.29%)  38/769 (4.94%) 
Colon dysplasia * 1  0/175 (0.00%)  1/769 (0.13%) 
Diarrhoea * 1  0/175 (0.00%)  1/769 (0.13%) 
Dyspepsia * 1  0/175 (0.00%)  1/769 (0.13%) 
Frequent bowel movements * 1  0/175 (0.00%)  1/769 (0.13%) 
Gastritis * 1  0/175 (0.00%)  1/769 (0.13%) 
Gastrointestinal perforation * 1  0/175 (0.00%)  1/769 (0.13%) 
Haematochezia * 1  0/175 (0.00%)  1/769 (0.13%) 
Haemorrhoids * 1  1/175 (0.57%)  1/769 (0.13%) 
Ileus * 1  0/175 (0.00%)  1/769 (0.13%) 
Inguinal hernia * 1  0/175 (0.00%)  1/769 (0.13%) 
Large intestine polyp * 1  0/175 (0.00%)  1/769 (0.13%) 
Megacolon * 1  1/175 (0.57%)  0/769 (0.00%) 
Nausea * 1  0/175 (0.00%)  1/769 (0.13%) 
Proctalgia * 1  1/175 (0.57%)  0/769 (0.00%) 
Proctitis * 1  0/175 (0.00%)  2/769 (0.26%) 
Rectal haemorrhage * 1  0/175 (0.00%)  1/769 (0.13%) 
Upper gastrointestinal haemorrhage * 1  1/175 (0.57%)  0/769 (0.00%) 
Vomiting * 1  0/175 (0.00%)  1/769 (0.13%) 
General disorders     
Chest discomfort * 1  1/175 (0.57%)  0/769 (0.00%) 
Chest pain * 1  1/175 (0.57%)  1/769 (0.13%) 
Fatigue * 1  1/175 (0.57%)  0/769 (0.00%) 
Oedema peripheral * 1  1/175 (0.57%)  0/769 (0.00%) 
Pyrexia * 1  1/175 (0.57%)  0/769 (0.00%) 
Hepatobiliary disorders     
Cholecystitis chronic * 1  1/175 (0.57%)  0/769 (0.00%) 
Cholelithiasis * 1  0/175 (0.00%)  2/769 (0.26%) 
Hepatic cirrhosis * 1  1/175 (0.57%)  0/769 (0.00%) 
Infections and infestations     
Anal abscess * 1  0/175 (0.00%)  2/769 (0.26%) 
Appendicitis * 1  0/175 (0.00%)  3/769 (0.39%) 
Arthritis bacterial * 1  0/175 (0.00%)  1/769 (0.13%) 
Atypical pneumonia * 1  0/175 (0.00%)  1/769 (0.13%) 
Bacterial vaginosis * 1  1/175 (0.57%)  0/769 (0.00%) 
Cellulitis staphylococcal * 1  0/175 (0.00%)  1/769 (0.13%) 
Clostridium difficile infection * 1  0/175 (0.00%)  1/769 (0.13%) 
Complicated appendicitis * 1  1/175 (0.57%)  0/769 (0.00%) 
Cytomegalovirus hepatitis * 1  0/175 (0.00%)  1/769 (0.13%) 
Diverticulitis * 1  1/175 (0.57%)  0/769 (0.00%) 
Enteritis infectious * 1  0/175 (0.00%)  1/769 (0.13%) 
Gastroenteritis * 1  0/175 (0.00%)  1/769 (0.13%) 
Herpes zoster * 1  1/175 (0.57%)  4/769 (0.52%) 
Herpes zoster meningitis * 1  0/175 (0.00%)  1/769 (0.13%) 
Histoplasmosis * 1  0/175 (0.00%)  1/769 (0.13%) 
Influenza * 1  0/175 (0.00%)  2/769 (0.26%) 
Lower respiratory tract infection * 1  0/175 (0.00%)  1/769 (0.13%) 
Mastoiditis * 1  0/175 (0.00%)  1/769 (0.13%) 
Meningitis viral * 1  0/175 (0.00%)  1/769 (0.13%) 
Necrotising fasciitis * 1  1/175 (0.57%)  0/769 (0.00%) 
Ophthalmic herpes zoster * 1  0/175 (0.00%)  2/769 (0.26%) 
Osteomyelitis * 1  0/175 (0.00%)  1/769 (0.13%) 
Perirectal abscess * 1  0/175 (0.00%)  1/769 (0.13%) 
Pilonidal cyst * 1  0/175 (0.00%)  1/769 (0.13%) 
Pulmonary mycosis * 1  1/175 (0.57%)  0/769 (0.00%) 
Sinusitis * 1  0/175 (0.00%)  2/769 (0.26%) 
Tonsillitis * 1  1/175 (0.57%)  0/769 (0.00%) 
Tuberculosis * 1  0/175 (0.00%)  1/769 (0.13%) 
Urinary tract infection * 1  0/175 (0.00%)  1/769 (0.13%) 
Urosepsis * 1  0/175 (0.00%)  1/769 (0.13%) 
Wound infection * 1  0/175 (0.00%)  1/769 (0.13%) 
Injury, poisoning and procedural complications     
Alcohol poisoning * 1  0/175 (0.00%)  1/769 (0.13%) 
Ankle fracture * 1  1/175 (0.57%)  2/769 (0.26%) 
Clavicle fracture * 1  0/175 (0.00%)  1/769 (0.13%) 
Fibula fracture * 1  1/175 (0.57%)  0/769 (0.00%) 
Foot fracture * 1  2/175 (1.14%)  0/769 (0.00%) 
Humerus fracture * 1  0/175 (0.00%)  1/769 (0.13%) 
Ligament rupture * 1  2/175 (1.14%)  0/769 (0.00%) 
Ligament sprain * 1  0/175 (0.00%)  1/769 (0.13%) 
Lower limb fracture * 1  0/175 (0.00%)  1/769 (0.13%) 
Meniscus injury * 1  1/175 (0.57%)  0/769 (0.00%) 
Muscle strain * 1  0/175 (0.00%)  1/769 (0.13%) 
Post procedural haemorrhage * 1  1/175 (0.57%)  0/769 (0.00%) 
Rib fracture * 1  0/175 (0.00%)  1/769 (0.13%) 
Spinal compression fracture * 1  0/175 (0.00%)  1/769 (0.13%) 
Spinal fracture * 1  0/175 (0.00%)  1/769 (0.13%) 
Tendon rupture * 1  0/175 (0.00%)  1/769 (0.13%) 
Toxicity to various agents * 1  0/175 (0.00%)  2/769 (0.26%) 
Upper limb fracture * 1  0/175 (0.00%)  1/769 (0.13%) 
Wrist fracture * 1  0/175 (0.00%)  1/769 (0.13%) 
Metabolism and nutrition disorders     
Dehydration * 1  0/175 (0.00%)  1/769 (0.13%) 
Musculoskeletal and connective tissue disorders     
Arthritis reactive * 1  0/175 (0.00%)  1/769 (0.13%) 
Back pain * 1  1/175 (0.57%)  2/769 (0.26%) 
Femoroacetabular impingement * 1  0/175 (0.00%)  1/769 (0.13%) 
Neck pain * 1  0/175 (0.00%)  1/769 (0.13%) 
Osteoarthritis * 1  0/175 (0.00%)  2/769 (0.26%) 
Rotator cuff syndrome * 1  0/175 (0.00%)  1/769 (0.13%) 
Spinal osteoarthritis * 1  1/175 (0.57%)  0/769 (0.00%) 
Spinal pain * 1  1/175 (0.57%)  0/769 (0.00%) 
Synovitis * 1  0/175 (0.00%)  1/769 (0.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia * 1  0/175 (0.00%)  1/769 (0.13%) 
Adenocarcinoma metastatic * 1  0/175 (0.00%)  1/769 (0.13%) 
Adenocarcinoma of colon * 1  0/175 (0.00%)  2/769 (0.26%) 
Adenoma benign * 1  0/175 (0.00%)  1/769 (0.13%) 
Basal cell carcinoma * 1  2/175 (1.14%)  2/769 (0.26%) 
Breast cancer * 1  2/175 (1.14%)  0/769 (0.00%) 
Cholangiocarcinoma * 1  1/175 (0.57%)  1/769 (0.13%) 
Colon adenoma * 1  0/175 (0.00%)  2/769 (0.26%) 
Colorectal cancer metastatic * 1  0/175 (0.00%)  1/769 (0.13%) 
Diffuse large B-cell lymphoma * 1  1/175 (0.57%)  0/769 (0.00%) 
Epstein-Barr virus associated lymphoma * 1  0/175 (0.00%)  1/769 (0.13%) 
Fibroadenoma of breast * 1  0/175 (0.00%)  1/769 (0.13%) 
Hepatic angiosarcoma * 1  0/175 (0.00%)  1/769 (0.13%) 
Invasive ductal breast carcinoma * 1  0/175 (0.00%)  1/769 (0.13%) 
Leiomyosarcoma * 1  0/175 (0.00%)  1/769 (0.13%) 
Lung neoplasm * 1  0/175 (0.00%)  1/769 (0.13%) 
Lung neoplasm malignant * 1  0/175 (0.00%)  1/769 (0.13%) 
Malignant melanoma * 1  0/175 (0.00%)  2/769 (0.26%) 
Meningioma * 1  0/175 (0.00%)  1/769 (0.13%) 
Metastases to liver * 1  1/175 (0.57%)  1/769 (0.13%) 
Metastases to lymph nodes * 1  1/175 (0.57%)  0/769 (0.00%) 
Metastases to peritoneum * 1  0/175 (0.00%)  1/769 (0.13%) 
Oesophageal adenocarcinoma * 1  0/175 (0.00%)  1/769 (0.13%) 
Renal cell carcinoma * 1  0/175 (0.00%)  1/769 (0.13%) 
Squamous cell carcinoma * 1  0/175 (0.00%)  1/769 (0.13%) 
Nervous system disorders     
Cerebellar haemorrhage * 1  1/175 (0.57%)  0/769 (0.00%) 
Cerebrovascular accident * 1  0/175 (0.00%)  1/769 (0.13%) 
Cervical radiculopathy * 1  1/175 (0.57%)  0/769 (0.00%) 
Headache * 1  0/175 (0.00%)  1/769 (0.13%) 
Ischaemic stroke * 1  1/175 (0.57%)  0/769 (0.00%) 
Loss of consciousness * 1  1/175 (0.57%)  0/769 (0.00%) 
Post herpetic neuralgia * 1  0/175 (0.00%)  1/769 (0.13%) 
Sciatica * 1  0/175 (0.00%)  2/769 (0.26%) 
Syncope * 1  0/175 (0.00%)  1/769 (0.13%) 
Vertebrobasilar insufficiency * 1  0/175 (0.00%)  1/769 (0.13%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  0/175 (0.00%)  1/769 (0.13%) 
Product Issues     
Device loosening * 1  1/175 (0.57%)  0/769 (0.00%) 
Psychiatric disorders     
Anxiety * 1  1/175 (0.57%)  0/769 (0.00%) 
Depression * 1  1/175 (0.57%)  0/769 (0.00%) 
Major depression * 1  0/175 (0.00%)  2/769 (0.26%) 
Suicide attempt * 1  0/175 (0.00%)  1/769 (0.13%) 
Renal and urinary disorders     
Calculus urinary * 1  0/175 (0.00%)  1/769 (0.13%) 
Haematuria * 1  0/175 (0.00%)  1/769 (0.13%) 
Nephrolithiasis * 1  1/175 (0.57%)  2/769 (0.26%) 
Prerenal failure * 1  0/175 (0.00%)  1/769 (0.13%) 
Renal colic * 1  0/175 (0.00%)  2/769 (0.26%) 
Ureteric obstruction * 1  0/175 (0.00%)  1/769 (0.13%) 
Ureterolithiasis * 1  0/175 (0.00%)  2/769 (0.26%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  0/175 (0.00%)  1/769 (0.13%) 
Cervical dysplasia * 1  0/175 (0.00%)  1/769 (0.13%) 
Cervix haemorrhage uterine * 1  1/175 (0.57%)  0/769 (0.00%) 
Ovarian cyst * 1  0/175 (0.00%)  1/769 (0.13%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/175 (0.57%)  0/769 (0.00%) 
Nasal polyps * 1  0/175 (0.00%)  1/769 (0.13%) 
Pulmonary embolism * 1  0/175 (0.00%)  5/769 (0.65%) 
Pulmonary mass * 1  1/175 (0.57%)  0/769 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne * 1  0/175 (0.00%)  1/769 (0.13%) 
Dermatitis contact * 1  0/175 (0.00%)  1/769 (0.13%) 
Eosinophilic pustular folliculitis * 1  0/175 (0.00%)  1/769 (0.13%) 
Erythema nodosum * 1  0/175 (0.00%)  1/769 (0.13%) 
1
Term from vocabulary, MedDRA 23.0
*
Indicates events were collected by non-systematic assessment
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   134/175 (76.57%)   550/769 (71.52%) 
Blood and lymphatic system disorders     
Anaemia * 1  3/175 (1.71%)  36/769 (4.68%) 
Lymphopenia * 1  6/175 (3.43%)  13/769 (1.69%) 
Gastrointestinal disorders     
Abdominal pain * 1  6/175 (3.43%)  47/769 (6.11%) 
Abdominal pain upper * 1  4/175 (2.29%)  24/769 (3.12%) 
Colitis ulcerative * 1  44/175 (25.14%)  131/769 (17.04%) 
Constipation * 1  7/175 (4.00%)  20/769 (2.60%) 
Diarrhoea * 1  9/175 (5.14%)  34/769 (4.42%) 
Dyspepsia * 1  8/175 (4.57%)  12/769 (1.56%) 
Gastrooesophageal reflux disease * 1  10/175 (5.71%)  15/769 (1.95%) 
Haemorrhoids * 1  3/175 (1.71%)  20/769 (2.60%) 
Nausea * 1  1/175 (0.57%)  30/769 (3.90%) 
Vomiting * 1  3/175 (1.71%)  20/769 (2.60%) 
General disorders     
Fatigue * 1  5/175 (2.86%)  33/769 (4.29%) 
Oedema peripheral * 1  4/175 (2.29%)  13/769 (1.69%) 
Pyrexia * 1  2/175 (1.14%)  25/769 (3.25%) 
Infections and infestations     
Bronchitis * 1  17/175 (9.71%)  30/769 (3.90%) 
Ear infection * 1  4/175 (2.29%)  6/769 (0.78%) 
Gastroenteritis * 1  12/175 (6.86%)  51/769 (6.63%) 
Herpes zoster * 1  12/175 (6.86%)  50/769 (6.50%) 
Influenza * 1  23/175 (13.14%)  63/769 (8.19%) 
Latent tuberculosis * 1  4/175 (2.29%)  13/769 (1.69%) 
Nasopharyngitis * 1  41/175 (23.43%)  157/769 (20.42%) 
Oral herpes * 1  1/175 (0.57%)  18/769 (2.34%) 
Pharyngitis * 1  8/175 (4.57%)  14/769 (1.82%) 
Pneumonia * 1  4/175 (2.29%)  9/769 (1.17%) 
Rhinitis * 1  5/175 (2.86%)  7/769 (0.91%) 
Sinusitis * 1  8/175 (4.57%)  25/769 (3.25%) 
Upper respiratory tract infection * 1  19/175 (10.86%)  77/769 (10.01%) 
Urinary tract infection * 1  13/175 (7.43%)  34/769 (4.42%) 
Viral upper respiratory tract infection * 1  5/175 (2.86%)  7/769 (0.91%) 
Injury, poisoning and procedural complications     
Ligament sprain * 1  4/175 (2.29%)  8/769 (1.04%) 
Skin laceration * 1  5/175 (2.86%)  4/769 (0.52%) 
Investigations     
Alanine aminotransferase increased * 1  6/175 (3.43%)  11/769 (1.43%) 
Aspartate aminotransferase increased * 1  5/175 (2.86%)  8/769 (1.04%) 
Blood cholesterol increased * 1  7/175 (4.00%)  18/769 (2.34%) 
Blood creatine phosphokinase increased * 1  19/175 (10.86%)  85/769 (11.05%) 
Lymphocyte count decreased * 1  3/175 (1.71%)  18/769 (2.34%) 
White blood cell count decreased * 1  4/175 (2.29%)  8/769 (1.04%) 
Metabolism and nutrition disorders     
Hypercholesterolaemia * 1  1/175 (0.57%)  38/769 (4.94%) 
Hyperlipidaemia * 1  4/175 (2.29%)  10/769 (1.30%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  17/175 (9.71%)  76/769 (9.88%) 
Back pain * 1  11/175 (6.29%)  28/769 (3.64%) 
Musculoskeletal pain * 1  2/175 (1.14%)  18/769 (2.34%) 
Myalgia * 1  6/175 (3.43%)  10/769 (1.30%) 
Osteoarthritis * 1  6/175 (3.43%)  9/769 (1.17%) 
Tendonitis * 1  5/175 (2.86%)  4/769 (0.52%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma * 1  4/175 (2.29%)  14/769 (1.82%) 
Nervous system disorders     
Dizziness * 1  4/175 (2.29%)  14/769 (1.82%) 
Headache * 1  12/175 (6.86%)  57/769 (7.41%) 
Paraesthesia * 1  2/175 (1.14%)  17/769 (2.21%) 
Psychiatric disorders     
Anxiety * 1  6/175 (3.43%)  16/769 (2.08%) 
Depression * 1  4/175 (2.29%)  12/769 (1.56%) 
Insomnia * 1  5/175 (2.86%)  18/769 (2.34%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  14/175 (8.00%)  38/769 (4.94%) 
Dyspnoea * 1  5/175 (2.86%)  7/769 (0.91%) 
Rhinorrhoea * 1  4/175 (2.29%)  4/769 (0.52%) 
Skin and subcutaneous tissue disorders     
Acne * 1  5/175 (2.86%)  20/769 (2.60%) 
Rash * 1  4/175 (2.29%)  38/769 (4.94%) 
Vascular disorders     
Hypertension * 1  17/175 (9.71%)  28/769 (3.64%) 
1
Term from vocabulary, MedDRA 23.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470612    
Other Study ID Numbers: A3921139
2011-004581-14 ( EudraCT Number )
OCTAVEOPEN ( Other Identifier: Alias Study Number )
First Submitted: October 21, 2011
First Posted: November 11, 2011
Results First Submitted: August 3, 2021
Results First Posted: September 17, 2021
Last Update Posted: September 17, 2021