A Phase 4 interventional study of CP-690,500 5 mg and CP-690,550 10 mg in Ulcerative Colitis, sponsored by Pfizer. Terminated at 80 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Pfizer · Phase 4, Interventional, and Treatment
Among 14 studies testing tofacitinib in Colitis, Ulcerative — 3 open to participants now, 6 under way, 1 of them phase 3. tofacitinib · Colitis, Ulcerative.
Among the 14 studies testing tofacitinib in Colitis, Ulcerative, this one is the 6th largest by enrollment, is the only one that started in 2017, is one of 4 in phase 4, and was the 6th registered.
1,854 studies on the registry are indexed under Colitis, Ulcerative; 473 are open to participants now.
Browse Colitis, Ulcerative studies →3 of the 14 studies testing tofacitinib in Colitis, Ulcerative are open now, in 1 country. Recruiting first, the newest first:
Asian Institute of Gastroenterology, India · Sites in India
Ages 18–65
Post Graduate Institute of Medical Education and Research, Chandigarh
Ages 18+
Post Graduate Institute of Medical Education and Research, Chandigarh
Ages 18–65
By country, each count listing its studies:
tofacitinib: first FDA approval 2012 (XELJANZ), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 307 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 136 (44%) stop at 75 or younger; 71 take children under 18; 41 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 4 · Phase 3 5 · Phase 4 4
First in 2008; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 140 is above the median of 70 across 1,237 interventional studies indexed under Colitis, Ulcerative.
Median enrollment 107 across the 14 interventional studies. Of the 8 that completed or were terminated, 6 (75%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 14 have an industry lead sponsor. The 7 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
42 studies in Colitis, Ulcerative by Pfizer: 3 open now, 7 under way, 2 of them phase 3. Of 32 finished, 26 (81%) have results posted.
Among the 42 studies in Colitis, Ulcerative by Pfizer, this one is the 12th largest by enrollment of the 24 interventional ones that give a count, is one of 3 that started in 2017, is the only one in phase 4, and was the 16th registered.
Pfizer’s Colitis, Ulcerative studies by the year they started, since 2005.
3 of the studies testing tofacitinib in Colitis, Ulcerative that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04624230Phase 3PfizerEvaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | 2027-03-17 |
| NCT07297069Asian Institute of Gastroenterology, IndiaCombination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial | 2027-05-31 |
| NCT06095128TakedaA Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC) | 2027-07-09 |
Add all 3 to your calendar (.ics) → With an account.
Among the 14 studies testing tofacitinib in Colitis, Ulcerative, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Pfizer’s 42 in Colitis, Ulcerative:
This tab as a report to print or save as PDF → With an account.
This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission designed to evaluate flexible dosing of CP-690,550.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects with any of the following risk factors for pulmonary embolism at baseline as defined by EMA's PRAC:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CP-690,550 5 mg tablet by mouth twice a day (BID)
Drug: CP-690,500 5 mg
CP-690,550 10 mg BID
Drug: CP-690,550 10 mg
CP-690,550 5 mg tablet BID
CP-690,550 10 mg tablet BID
Number of Participants With Remission Based on Modified Mayo Score at Month 6
Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.
Time frame: Month 6
Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method
Time to loss of remission(flare): time from first drug administration until time of meeting loss of remission criteria based on modified mayo score. Loss of remission: meeting at least (\>=)1 criteria: increase from Baseline in rectal bleeding subscore by \>=1 point and increase in endoscopic subscore by \>=1 point; increase from Baseline in rectal bleeding subscore by \>=2 points and endoscopic subscore \>0; increase in stool frequency subscore by \>=2 points and increase in endoscopic subscore by \>=1 point; increase in endoscopic subscore by \>=2 points. Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores: Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores, each subscore graded from 0 to 3 with higher scores for each score=more severe disease. All scores summed up to give total modified mayo score range from 0 to 9; higher scores=more severe disease.
Time frame: Up to Month 42
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Remission as per modified partial mayo score was defined as stool frequency subscore of 0 or 1, and rectal bleeding sub score of 0 at the specified time points. Modified partial mayo scores consisted of 2 components: stool frequency and rectal bleeding: each subscore graded from 0 to 3 with higher scores for each score = more severe disease. These scores were summed up to give a total modified partial mayo score range of 0 to 6; where higher scores indicating more severe disease.
Time frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42
Remission as per total mayo score was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
Time frame: Months 6, 18, 30 and 42
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Remission as per partial mayo score was defined as partial mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
Time frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42
Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.
Time frame: Months 18, 30 and 42
Change From Baseline in Modified Mayo Score at Month 6
Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.
Time frame: Baseline, Month 6
Change From Baseline in Modified Mayo Score at Months 18, 30 and 42
Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.
Time frame: Baseline, Months 18, 30 and 42
Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6
Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total Modified partial mayo score ranges from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.
Time frame: Baseline, Months 1, 3 and 6
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total modified partial mayo score range from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.
Time frame: Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change From Baseline in Total Mayo Score at Month 6
Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
Time frame: Baseline, Month 6
Change From Baseline in Total Mayo Score at Months 18, 30 and 42
Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
Time frame: Baseline, Months 18, 30 and 42
Change From Baseline in Partial Mayo Score at Months 1, 3 and 6
Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
Time frame: Baseline, Months 1, 3 and 6
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
Time frame: Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42
Mucosal healing in participants was defined as the mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicated more severe disease.
Time frame: Months 6, 18, 30 and 42
Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42
Clinical response was defined as a decrease from baseline in mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a mayo score range of 0 to 12, where higher scores indicating more severe disease.
Time frame: Months 6, 18, 30 and 42
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change from baseline in fecal calprotectin (in micrograms per gram \[mcg/g\]) was reported.
Time frame: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change From baseline in hs-CRP level (in milligrams per liter \[mg/L\]) is reported.
Time frame: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product 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; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events (irrespective of frequency threshold used to report other AEs in safety section).
Time frame: Baseline up to 43 months
Number of Participants With Serious Infections
Serious infections were defined as any infections (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy, hospitalization for treatment, or meeting other criteria that require the infection to be classified as serious adverse event. 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; medically important events.
Time frame: Baseline up to 43 months
Number of Participants With Clinical Laboratory Abnormalities
Abnormality criteria: Hematology: hemoglobin(Hg): \<0.8\* lower limit of normal (LLN); hematocrit: \<0.8\*LLN; lymphocytes: \<0.8\* LLN; lymphocytes/leukocytes: \<0.8\*LLN; erythrocytes: \<0.8\*LLN; erythrocytes mean corpuscular volume: \<0.9\*LLN; erythrocytes mean corpuscular Hg: \<0.9\*LLN; reticulocytes, reticulocytes/erythrocytes:\>1.5\* upper limit of normal (ULN); neutrophils, neutrophils/leukocytes: \>1.2\*ULN; basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes/leukocytes: \>1.2\*ULN; leukocyte esterase: \>=1; Clinical chemistry: bicarbonate:\<0.9\*LLN, bilirubin: \>1.5\*ULN; indirect bilirubin: \>1.5\* ULN; aspartate aminotransferase(AT): \>3.0\*ULN; alanine AT: \>3.0\*ULN; gamma glutamyl transferase: \>3.0\* ULN; creatine kinase: \>2.0\*ULN; potassium: \>1.1\*ULN; blood urea nitrogen: \>1.3\*ULN; creatinine: \>1.3\*ULN; urate: \>1.2\*ULN; cholesterol: \>1.3\*ULN; HDL-cholesterol: \<0.8\* LLN; LDL-cholesterol: \>1.2\*ULN; triglycerides: \>1.3\*ULN; glucose: \>1.5\*ULN; and urine Hg \>=1.
Time frame: Baseline up to 27 months
Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation
Laboratory abnormalities leading to study treatment discontinuation: 2 sequential neutrophil counts \<750 neutrophils per cubic millimeter (mm\^3); 2 sequential lymphocyte counts \<500 lymphocytes/mm\^3; 2 sequential hemoglobin \<8.0 grams per deciliter; 2 sequential platelet counts \<75000 platelets/mm\^3; 2 sequential AST or ALT elevations \>=3\*ULN with at least one total bilirubin value \>=2\*ULN; 2 sequential AST or ALT elevations \>=3\*ULN accompanied by signs or symptoms consistent with hepatic injury; 2 sequential AST or ALT elevations \>=5\*ULN; 2 sequential increases in creatinine \>50% and \>0.5 milligrams per deciliter over A3921139 baseline; 2 sequential CK elevations \>10\*ULN unless the causality is known not to be medically serious (eg, exercise induced).
Time frame: Baseline up to 43 months
Number of Participants With Vital Sign Abnormalities
Vital signs abnormality criteria included: 1) a) diastolic blood pressure (DBP) of (less than) \<50 millimeter of mercury (mmHg), b) change greater than equal to (\>=) 20 mmHg increase, c) change \>=20 mmHg decrease; 2) a) systolic blood pressure (SBP) of \<90 mmHg, b) change \>=30 mmHg increase, c) change \>=30 mmHg decrease; 3) a) pulse rate value of \<40 beats per minute (bpm), b) pulse rate \>120 bpm. Only those categories in which at least 1 participant had data were reported.
Time frame: Baseline up to 43 months
Number of Participants With Clinically Significant Physical Examinations Abnormalities
Physical examination included assessment of the weight, general appearance, eyes, mouth, lungs, heart, abdomen, musculoskeletal, extremities, skin and lymph nodes. Clinical significance was assessed by the Investigator.
Time frame: Baseline up to 43 months
Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee
Number of participants with adjudicated opportunistic infections including herpes zoster (non-adjacent or \>2 adjacent dermatomes); all malignancies including non-melanoma skin cancer; gastrointestinal perforation and cardiovascular events including pulmonary embolism and cerebrovascular accident, adjudicated by adjudication committee were reported.
Time frame: Baseline up to 43 months
The study enrolled participants from A3921139 (NCT01470612) who were on tofacitinib 10 milligram (mg) twice daily (BID) for at least 2 consecutive years, who were in stable remission for at least 6 months prior to baseline of A3921288 and who were not receiving any corticosteroid treatment to treat their ulcerative colitis (UC) for at least 4 weeks prior to enrollment.
| Milestone | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Started | 70 | 70 |
| Completed | 36 | 27 |
| Not completed | 34 | 43 |
| Withdrew: Adverse event | 10 | 10 |
| Withdrew: Lack of efficacy | 3 | 2 |
| Withdrew: Pregnancy | 1 | 0 |
| Withdrew: Withdrawal by subject | 5 | 12 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Study terminated by sponsor | 15 | 16 |
| Withdrew: Other | 0 | 2 |
| Milestone | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Started | 63 | 57 |
| Completed | 61 | 56 |
| Not completed | 2 | 1 |
| Withdrew: Other | 2 | 1 |
Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Number of Participants With Remission Based on Modified Mayo Score at Month 6 | 54 | 63 |
Time to loss of remission(flare): time from first drug administration until time of meeting loss of remission criteria based on modified mayo score. Loss of remission: meeting at least (\>=)1 criteria: increase from Baseline in rectal bleeding subscore by \>=1 point and increase in endoscopic subscore by \>=1 point; increase from Baseline in rectal bleeding subscore by \>=2 points and endoscopic subscore \>0; increase in stool frequency subscore by \>=2 points and increase in endoscopic subscore by \>=1 point; increase in endoscopic subscore by \>=2 points. Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores: Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores, each subscore graded from 0 to 3 with higher scores for each score=more severe disease. All scores summed up to give total modified mayo score range from 0 to 9; higher scores=more severe disease.
| Days | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method | NA (29 to 1268) | 1270 (28 to 1270) |
Remission as per modified partial mayo score was defined as stool frequency subscore of 0 or 1, and rectal bleeding sub score of 0 at the specified time points. Modified partial mayo scores consisted of 2 components: stool frequency and rectal bleeding: each subscore graded from 0 to 3 with higher scores for each score = more severe disease. These scores were summed up to give a total modified partial mayo score range of 0 to 6; where higher scores indicating more severe disease.
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Month 1 | 62 | 64 |
| Month 3 | 57 | 65 |
| Month 6 | 57 | 67 |
| Month 9 | 52 | 66 |
| Month 12 | 50 | 61 |
| Month 15 | 48 | 58 |
| Month 18 | 45 | 55 |
| Month 21 | 46 | 51 |
| Month 24 | 47 | 51 |
| Month 27 | 43 | 49 |
| Month 30 | 44 | 46 |
| Month 33 | 42 | 43 |
| Month 36 | 42 | 44 |
| Month 39 | 40 | 37 |
| Month 42 | 26 | 29 |
Remission as per total mayo score was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Month 6 | 53 | 61 |
| Month 18 | 33 | 47 |
| Month 30 | 35 | 44 |
| Month 42 | 22 | 24 |
Remission as per partial mayo score was defined as partial mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Month 1 | 62 | 64 |
| Month 3 | 57 | 65 |
| Month 6 | 56 | 66 |
| Month 9 | 52 | 66 |
| Month 12 | 50 | 61 |
| Month 15 | 48 | 58 |
| Month 18 | 44 | 55 |
| Month 21 | 46 | 50 |
| Month 24 | 46 | 51 |
| Month 27 | 42 | 49 |
| Month 30 | 43 | 46 |
| Month 33 | 42 | 43 |
| Month 36 | 42 | 44 |
| Month 39 | 39 | 37 |
| Month 42 | 26 | 28 |
Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Month 18 | 37 | 48 |
| Month 30 | 35 | 44 |
| Month 42 | 23 | 24 |
Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.
| Units on a scale | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Change From Baseline in Modified Mayo Score at Month 6 | 0.6 ± 0.2 | 0.3 ± 0.2 |
Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.
| Units on a scale | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Change at Month 18 | 0.5 ± 1.3 | 0.3 ± 1.5 |
| Change at Month 30 | 0.3 ± 1.2 | 0.1 ± 0.9 |
| Change at Month 42 | 0.3 ± 0.9 | 0.2 ± 1.1 |
Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total Modified partial mayo score ranges from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.
| Units on a scale | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Change at Month 1 | 0.1 ± 0.1 | 0.2 ± 0.1 |
| Change at Month 3 | 0.2 ± 0.1 | 0.1 ± 0.1 |
| Change at Month 6 | 0.1 ± 0.1 | 0.2 ± 0.1 |
Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total modified partial mayo score range from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.
| Units on a scale | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Change at Month 9 | 0.1 ± 0.7 | 0.1 ± 0.6 |
| Change at Month 12 | 0.1 ± 0.5 | 0.1 ± 0.7 |
| Change at Month 15 | 0.2 ± 0.8 | 0.1 ± 0.6 |
| Change at Month 18 | 0.1 ± 0.6 | 0.1 ± 0.8 |
| Change at Month 21 | 0.1 ± 0.5 | 0.2 ± 1.1 |
| Change at Month 24 | 0.0 ± 0.5 | 0.0 ± 0.6 |
| Change at Month 27 | 0.1 ± 0.5 | 0.1 ± 0.7 |
| Change at Month 30 | 0.1 ± 0.7 | 0.0 ± 0.6 |
| Change at Month 33 | 0.0 ± 0.4 | 0.2 ± 0.7 |
| Change at Month 36 | 0.0 ± 0.5 | 0.0 ± 0.5 |
| Change at Month 39 | 0.0 ± 0.5 | 0.0 ± 0.5 |
| Change at Month 42 | 0.1 ± 0.4 | 0.1 ± 0.7 |
Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
| Units on a scale | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Change From Baseline in Total Mayo Score at Month 6 | 0.9 ± 0.2 | 0.4 ± 0.3 |
Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
| Units on a scale | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Change at Month 18 | 0.7 ± 1.7 | 0.4 ± 1.9 |
| Change at Month 30 | 0.4 ± 1.4 | 0.1 ± 1.2 |
| Change at Month 42 | 0.4 ± 1.2 | 0.2 ± 1.4 |
Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
| Units on a scale | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Change at Month 1 | 0.2 ± 0.1 | 0.2 ± 0.1 |
| Change at Month 3 | 0.3 ± 0.1 | 0.2 ± 0.1 |
| Change at Month 6 | 0.3 ± 0.1 | 0.3 ± 0.1 |
Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
| Units on a scale | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Change at Month 9 | 0.2 ± 0.8 | 0.2 ± 0.9 |
| Change at Month 12 | 0.1 ± 0.7 | 0.2 ± 0.9 |
| Change at Month 15 | 0.3 ± 1.2 | 0.1 ± 0.8 |
| Change at Month 18 | 0.2 ± 0.8 | 0.2 ± 1.2 |
| Change at Month 21 | 0.1 ± 0.7 | 0.4 ± 1.7 |
| Change at Month 24 | 0.1 ± 0.6 | 0.0 ± 0.8 |
| Change at Month 27 | 0.1 ± 0.6 | 0.1 ± 0.9 |
| Change at Month 30 | 0.2 ± 0.8 | 0.1 ± 0.8 |
| Change at Month 33 | 0.0 ± 0.5 | 0.2 ± 1.0 |
| Change at Month 36 | 0.0 ± 0.6 | -0.1 ± 0.6 |
| Change at Month 39 | 0.1 ± 0.6 | -0.1 ± 0.6 |
| Change at Month 42 | 0.1 ± 0.5 | 0.2 ± 1.1 |
Mucosal healing in participants was defined as the mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicated more severe disease.
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Month 6 | 56 | 64 |
| Month 18 | 43 | 56 |
| Month 30 | 38 | 47 |
| Month 42 | 36 | 36 |
Clinical response was defined as a decrease from baseline in mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a mayo score range of 0 to 12, where higher scores indicating more severe disease.
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Month 6 | 59 | 67 |
| Month 18 | 42 | 50 |
| Month 30 | 41 | 48 |
| Month 42 | 26 | 28 |
Change from baseline in fecal calprotectin (in micrograms per gram \[mcg/g\]) was reported.
| Micrograms per gram | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Change at Month 1 | -137.5 ± 980.6 | -21.9 ± 304.7 |
| Change at Month 3 | -45.3 ± 1075.8 | -38.5 ± 313.6 |
| Change at Month 6 | -24.1 ± 1444.6 | -47.3 ± 331.4 |
| Change at Month 9 | -173.5 ± 1106.5 | -59.3 ± 380.8 |
| Change at Month 12 | -28.8 ± 1113.4 | -45.0 ± 350.7 |
| Change at Month 15 | -104.8 ± 1210.2 | 69.3 ± 480.5 |
| Change at Month 18 | -51.0 ± 1114.6 | 6.6 ± 565.4 |
| Change at Month 21 | -71.0 ± 1254.6 | -29.3 ± 462.7 |
| Change at Month 24 | 118.3 ± 1591.4 | -69.8 ± 407.0 |
| Change at Month 27 | 87.3 ± 478.8 | -49.1 ± 366.3 |
| Change at Month 30 | -8.5 ± 458.5 | -8.9 ± 518.5 |
| Change at Month 33 | 84.4 ± 434.5 | -4.9 ± 484.8 |
| Change at Month 36 | 230.7 ± 1162.5 | -0.4 ± 449.4 |
| Change at Month 39 | -116.2 ± 472.8 | -98.3 ± 532.9 |
| Change at Month 42 | -44.7 ± 278.9 | -101.0 ± 452.0 |
Change From baseline in hs-CRP level (in milligrams per liter \[mg/L\]) is reported.
| Milligrams per liter | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Change at Month 1 | 1.1 ± 9.8 | -0.7 ± 3.4 |
| Change at Month 3 | 0.7 ± 7.9 | -0.2 ± 3.7 |
| Change at Month 6 | 0.9 ± 5.8 | 0.1 ± 4.0 |
| Change at Month 9 | 0.7 ± 11.1 | 1.1 ± 8.4 |
| Change at Month 12 | -0.3 ± 3.5 | -0.2 ± 2.2 |
| Change at Month 15 | -0.7 ± 3.2 | 0.2 ± 2.4 |
| Change at Month 18 | 1.0 ± 6.4 | 0.2 ± 1.9 |
| Change at Month 21 | -0.5 ± 3.3 | -0.1 ± 1.4 |
| Change at Month 24 | -0.6 ± 3.0 | -0.5 ± 2.2 |
| Change at Month 27 | -0.3 ± 2.8 | 0.7 ± 6.1 |
| Change at Month 30 | 0.6 ± 4.1 | -0.3 ± 1.9 |
| Change at Month 33 | 0.1 ± 2.2 | 0.0 ± 3.9 |
| Change at Month 36 | -0.1 ± 3.1 | -0.1 ± 3.9 |
| Change at Month 39 | -0.3 ± 3.5 | 2.8 ± 8.6 |
| Change at Month 42 | 0.6 ± 3.7 | 5.9 ± 28.1 |
An AE was any untoward medical occurrence in a participant who received investigational product 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; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events (irrespective of frequency threshold used to report other AEs in safety section).
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| TEAEs | 55 | 58 |
| SAEs | 7 | 16 |
Serious infections were defined as any infections (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy, hospitalization for treatment, or meeting other criteria that require the infection to be classified as serious adverse event. 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; medically important events.
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Number of Participants With Serious Infections | 3 | 6 |
Abnormality criteria: Hematology: hemoglobin(Hg): \<0.8\* lower limit of normal (LLN); hematocrit: \<0.8\*LLN; lymphocytes: \<0.8\* LLN; lymphocytes/leukocytes: \<0.8\*LLN; erythrocytes: \<0.8\*LLN; erythrocytes mean corpuscular volume: \<0.9\*LLN; erythrocytes mean corpuscular Hg: \<0.9\*LLN; reticulocytes, reticulocytes/erythrocytes:\>1.5\* upper limit of normal (ULN); neutrophils, neutrophils/leukocytes: \>1.2\*ULN; basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes/leukocytes: \>1.2\*ULN; leukocyte esterase: \>=1; Clinical chemistry: bicarbonate:\<0.9\*LLN, bilirubin: \>1.5\*ULN; indirect bilirubin: \>1.5\* ULN; aspartate aminotransferase(AT): \>3.0\*ULN; alanine AT: \>3.0\*ULN; gamma glutamyl transferase: \>3.0\* ULN; creatine kinase: \>2.0\*ULN; potassium: \>1.1\*ULN; blood urea nitrogen: \>1.3\*ULN; creatinine: \>1.3\*ULN; urate: \>1.2\*ULN; cholesterol: \>1.3\*ULN; HDL-cholesterol: \<0.8\* LLN; LDL-cholesterol: \>1.2\*ULN; triglycerides: \>1.3\*ULN; glucose: \>1.5\*ULN; and urine Hg \>=1.
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Number of Participants With Clinical Laboratory Abnormalities | 33 | 51 |
Laboratory abnormalities leading to study treatment discontinuation: 2 sequential neutrophil counts \<750 neutrophils per cubic millimeter (mm\^3); 2 sequential lymphocyte counts \<500 lymphocytes/mm\^3; 2 sequential hemoglobin \<8.0 grams per deciliter; 2 sequential platelet counts \<75000 platelets/mm\^3; 2 sequential AST or ALT elevations \>=3\*ULN with at least one total bilirubin value \>=2\*ULN; 2 sequential AST or ALT elevations \>=3\*ULN accompanied by signs or symptoms consistent with hepatic injury; 2 sequential AST or ALT elevations \>=5\*ULN; 2 sequential increases in creatinine \>50% and \>0.5 milligrams per deciliter over A3921139 baseline; 2 sequential CK elevations \>10\*ULN unless the causality is known not to be medically serious (eg, exercise induced).
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation | 1 | 1 |
Vital signs abnormality criteria included: 1) a) diastolic blood pressure (DBP) of (less than) \<50 millimeter of mercury (mmHg), b) change greater than equal to (\>=) 20 mmHg increase, c) change \>=20 mmHg decrease; 2) a) systolic blood pressure (SBP) of \<90 mmHg, b) change \>=30 mmHg increase, c) change \>=30 mmHg decrease; 3) a) pulse rate value of \<40 beats per minute (bpm), b) pulse rate \>120 bpm. Only those categories in which at least 1 participant had data were reported.
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| DBP: <50 mmHg | 3 | 0 |
| DBP: Change >= 20mmHg increase | 9 | 5 |
| DBP: Change >= 20mmHg decrease | 7 | 7 |
| SBP: <90mmHg | 2 | 0 |
| SBP: Change >= 30mmHg increase | 7 | 4 |
| SBP: Change >= 30mmHg decrease | 6 | 6 |
Physical examination included assessment of the weight, general appearance, eyes, mouth, lungs, heart, abdomen, musculoskeletal, extremities, skin and lymph nodes. Clinical significance was assessed by the Investigator.
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Number of Participants With Clinically Significant Physical Examinations Abnormalities | 28 | 27 |
Number of participants with adjudicated opportunistic infections including herpes zoster (non-adjacent or \>2 adjacent dermatomes); all malignancies including non-melanoma skin cancer; gastrointestinal perforation and cardiovascular events including pulmonary embolism and cerebrovascular accident, adjudicated by adjudication committee were reported.
| Participants | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Opportunistic Infections | 0 | 1 |
| All Malignancy | 4 | 3 |
| Gastrointestinal Perforation | 0 | 0 |
| Cardiovascular Events | 2 | 2 |
Collected over From baseline up to 4 weeks after last dose (maximum up to 43 months). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tofacitinib 5 mg BID | 0/70 (0%) | 7/70 (10%) | 47/70 (67.1%) |
| Tofacitinib 10 mg BID | 1/70 (1.4%) | 16/70 (22.9%) | 47/70 (67.1%) |
| Event | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| COVID-19Infections and infestations | 0/70 | 2/70 |
| COVID-19 pneumoniaInfections and infestations | 0/70 | 2/70 |
| Angina pectorisCardiac disorders | 0/70 | 1/70 |
| CellulitisInfections and infestations | 1/70 | 0/70 |
| Urinary tract infectionInfections and infestations | 1/70 | 0/70 |
| Limb injuryInjury, poisoning and procedural complications | 0/70 | 1/70 |
| Back painMusculoskeletal and connective tissue disorders | 0/70 | 1/70 |
| Squamous cell carcinoma of the vulvaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/70 | 0/70 |
| Cerebrovascular accidentNervous system disorders | 1/70 | 0/70 |
| Breast disorderReproductive system and breast disorders | 1/70 | 0/70 |
| Event | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID |
|---|---|---|
| Colitis ulcerativeGastrointestinal disorders | 16/70 | 14/70 |
| NasopharyngitisInfections and infestations | 7/70 | 8/70 |
| SARS-CoV-2 test positiveInvestigations | 2/70 | 7/70 |
| Abdominal painGastrointestinal disorders | 5/70 | 3/70 |
| BronchitisInfections and infestations | 1/70 | 5/70 |
| Herpes zosterInfections and infestations | 2/70 | 5/70 |
| Oral herpesInfections and infestations | 5/70 | 0/70 |
| Blood creatine phosphokinase increasedInvestigations | 2/70 | 5/70 |
| HypertensionVascular disorders | 4/70 | 5/70 |
| LymphopeniaBlood and lymphatic system disorders | 2/70 | 5/70 |
Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
| Age, Categorical(Participants) | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 59 | 63 | 122 |
| >=65 years | 11 | 7 | 18 |
| Sex: Female, Male(Participants) | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Total |
|---|---|---|---|
| Female | 26 | 22 | 48 |
| Male | 44 | 48 | 92 |
| Ethnicity (NIH/OMB)(Participants) | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 68 | 67 | 135 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 15 | 14 | 29 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 3 |
| White | 50 | 50 | 100 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 2 | 5 | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
Ran from Nov 2017 to primary completion in Feb 2020, 26 months.
Results were first posted in Apr 2021, 1 year 2 months after primary completion.
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Studies of the drug tested here: Tofacitinib