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A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission

Primary Purpose

Ulcerative Colitis

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
CP-690,500 5 mg
CP-690,550 10 mg
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring ulcerative colitis, inflammatory bowel disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2 years consecutively.
  • In stable remission on CP-690,550 10 mg BID
  • Agree to use highly effective contraception
  • Negative pregnancy test
  • Comply with visits, treatments, lab tests, diary and other study procedures
  • Signed and dated informed consent document.

Exclusion Criteria:

  • Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy.
  • Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis or findings suggestive of Crohn's disease
  • Likely to require surgery for ulcerative colitis during study
  • Expected to receive any prohibited medication
  • Expected to receive live or attenuated virus vaccination during study
  • Women who are pregnant or breastfeeding or planning to become pregnant during the study
  • Evidence of colonic malignancy or any dysplasia
  • Acute or chronic medical or psychiatric condition that may increase risk of participation
  • Investigator site staff member
  • Subjects likely to be uncooperative or unable to comply with study procedures
  • Participation in other studies involving investigational drugs during study

  • Subjects with any of the following risk factors for pulmonary embolism at baseline as defined by EMA's PRAC:

    • has heart failure;
    • has inherited coagulation disorders;
    • has had venous thromboembolism, either deep venous thrombosis or pulmonary embolism;
    • is taking combined hormonal contraceptives or hormone replacement therapy;
    • has malignancy (association is strongest with cancers other than non-melanoma skin cancers);
    • is undergoing major surgery

Sites / Locations

  • Surgicare of Mobile
  • Alabama Medical Group, P.C.
  • Clinical Applications Laboratories, Inc.
  • Bristol Hospital
  • Connecticut Clinical Research Institute
  • Central Connecticut Endoscopy Center
  • Advanced Medical Research Center
  • Florida Medical Clinic, P.A.
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Chevy Chase Endoscopy Center
  • MGG Group Co., Inc., Chevy Chase Clinical Research
  • Clinical Research Institute of Michigan, LLC
  • Eastside Endoscopy Center
  • Clinical Research Institute of Michigan, LLC
  • NYU Langone Long Island Clinical Research Associates
  • Columbia University Irving Medical Center
  • Columbia University Medical Center Research Pharmacy/ Milstein Hospital
  • Great Lakes Gastroenterology Research, LLC
  • Memorial Hermann Hospital
  • The University of Texas Health Science Center at Houston (UTHealth)- McGovern Medical School
  • Christus Trinity Mother Frances Endoscopy Center
  • Tyler Research Institute, LLC
  • Alpine Medical Group
  • Wasatch Clinical Research, LLC
  • UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
  • London Health Sciences Centre - University Hospital
  • Royal University Hospital
  • Nemocnice Strakonice a.s.
  • CHU Hotel Dieu
  • CHU de Bordeaux Hopital Haut Leveque
  • Universitaetsklinikum Schleswig-Holstein
  • Szent Janos Korhaz és Eszak-budai Egyesitett Korhazak
  • Pannonia Maganorvosi Centrum Kft.
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Endoszkopos Laboratorium
  • Università "Magna Graecia" di Catanzaro
  • Aichi Medical University Hospital
  • Fukuoka University Chikushi Hospital
  • Kurume University Hospital
  • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
  • Osaka Medical and Pharmaceutical University Hospital
  • Shiga University of Medical Science Hospital
  • Tokyo Medical And Dental University Hospital, Faculty of Medicine
  • Tokai University Hachioji Hospital
  • Kitasato University Kitasato Institute Hospital
  • Showa University Hospital
  • Toho University Sakura Medical Center
  • Hiroshima University Hospital
  • Osaka Metropolitan University Hospital
  • Keio University Hospital
  • Hanyang University Guri Hospital
  • Kyung Hee University Hospital
  • Severance Hospital, Yonsei University Health System
  • Academic Medical Centre
  • North Shore Hospital (Waitemata District Health Board)
  • Christchurch Hospital (Canterbury District Health Board)
  • Southern District Health Board
  • Endoskopia Sp. z o.o.
  • Lexmedica
  • Federal State Budgetary Institution "State Scientific Centre of Coloproctology
  • LLC Novosibirskiy Gastrocenter
  • Federal State Budgetary Scientific Institution "Scientific Research Institute of Physiology
  • Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
  • Clinical Hospital Centre Zvezdara
  • Military Medical Academy, Clinic for Gastroenterology and Hepatology
  • Clinical Center Kragujevac
  • General Hospital "Djordje Joanovic"
  • Medak s.r.o.
  • KM Management spol. s.r.o.
  • Gastro I., s.r.o., Gastroenterologicka ambulancia
  • Kingsbury Hospital
  • Wits Clinical Research (WCR) Bara Site, Chris Hani Baragwanath Academic Hospital
  • Chris Hani Baragwanath Academic Hospital
  • Endocare Research Centre
  • Panorama Mediclinic
  • Hospital Clinic de Barcelona
  • Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Clinical Hospital" Surgery Departm
  • Kyiv Municipal Clinical Hospital #18
  • MI Uzhgorod Regional Hospital
  • Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2
  • University Hospitals Bristol NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CP-690,550 5 mg

CP-690,550 10 mg

Arm Description

CP-690,550 5 mg tablet by mouth twice a day (BID)

CP-690,550 10 mg BID

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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).
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.
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.
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.

Full Information

First Posted
September 11, 2017
Last Updated
February 21, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03281304
Brief Title
A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
Official Title
A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
The study terminated early due to business reasons, with the study already meeting its primary objective. The decision to terminate the trial was not based on any safety and/or efficacy concerns.
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
March 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
ulcerative colitis, inflammatory bowel disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CP-690,550 5 mg
Arm Type
Experimental
Arm Description
CP-690,550 5 mg tablet by mouth twice a day (BID)
Arm Title
CP-690,550 10 mg
Arm Type
Experimental
Arm Description
CP-690,550 10 mg BID
Intervention Type
Drug
Intervention Name(s)
CP-690,500 5 mg
Intervention Description
CP-690,550 5 mg tablet BID
Intervention Type
Drug
Intervention Name(s)
CP-690,550 10 mg
Intervention Description
CP-690,550 10 mg tablet BID
Primary Outcome Measure Information:
Title
Number of Participants With Remission Based on Modified Mayo Score at Month 6
Description
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
Secondary Outcome Measure Information:
Title
Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method
Description
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
Title
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
Description
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
Title
Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42
Description
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
Title
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
Description
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
Title
Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42
Description
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
Title
Change From Baseline in Modified Mayo Score at Month 6
Description
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
Title
Change From Baseline in Modified Mayo Score at Months 18, 30 and 42
Description
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
Title
Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6
Description
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
Title
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Description
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
Title
Change From Baseline in Total Mayo Score at Month 6
Description
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
Title
Change From Baseline in Total Mayo Score at Months 18, 30 and 42
Description
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
Title
Change From Baseline in Partial Mayo Score at Months 1, 3 and 6
Description
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
Title
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Description
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
Title
Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42
Description
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
Title
Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42
Description
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
Title
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Description
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
Title
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
Description
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
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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
Title
Number of Participants With Serious Infections
Description
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
Title
Number of Participants With Clinical Laboratory Abnormalities
Description
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
Title
Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation
Description
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
Title
Number of Participants With Vital Sign Abnormalities
Description
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
Title
Number of Participants With Clinically Significant Physical Examinations Abnormalities
Description
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
Title
Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2 years consecutively. In stable remission on CP-690,550 10 mg BID Agree to use highly effective contraception Negative pregnancy test Comply with visits, treatments, lab tests, diary and other study procedures Signed and dated informed consent document. Exclusion Criteria: Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis or findings suggestive of Crohn's disease Likely to require surgery for ulcerative colitis during study Expected to receive any prohibited medication Expected to receive live or attenuated virus vaccination during study Women who are pregnant or breastfeeding or planning to become pregnant during the study Evidence of colonic malignancy or any dysplasia Acute or chronic medical or psychiatric condition that may increase risk of participation Investigator site staff member Subjects likely to be uncooperative or unable to comply with study procedures Participation in other studies involving investigational drugs during study Subjects with any of the following risk factors for pulmonary embolism at baseline as defined by EMA's PRAC: has heart failure; has inherited coagulation disorders; has had venous thromboembolism, either deep venous thrombosis or pulmonary embolism; is taking combined hormonal contraceptives or hormone replacement therapy; has malignancy (association is strongest with cancers other than non-melanoma skin cancers); is undergoing major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Surgicare of Mobile
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36606
Country
United States
Facility Name
Alabama Medical Group, P.C.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Clinical Applications Laboratories, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Bristol Hospital
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Connecticut Clinical Research Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Central Connecticut Endoscopy Center
City
Plainville
State/Province
Connecticut
ZIP/Postal Code
06062
Country
United States
Facility Name
Advanced Medical Research Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Florida Medical Clinic, P.A.
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Chevy Chase Endoscopy Center
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
MGG Group Co., Inc., Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Eastside Endoscopy Center
City
Macomb
State/Province
Michigan
ZIP/Postal Code
48044
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
NYU Langone Long Island Clinical Research Associates
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Columbia University Medical Center Research Pharmacy/ Milstein Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at Houston (UTHealth)- McGovern Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Christus Trinity Mother Frances Endoscopy Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Alpine Medical Group
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Wasatch Clinical Research, LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Nemocnice Strakonice a.s.
City
Strakonice
ZIP/Postal Code
386 01
Country
Czechia
Facility Name
CHU Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Bordeaux Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Szent Janos Korhaz és Eszak-budai Egyesitett Korhazak
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum Kft.
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Endoszkopos Laboratorium
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Università "Magna Graecia" di Catanzaro
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy
Facility Name
Aichi Medical University Hospital
City
Nagakute
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino
State/Province
Fukuoka
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Tokyo Medical And Dental University Hospital, Faculty of Medicine
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Tokai University Hachioji Hospital
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
Kitasato University Kitasato Institute Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Hanyang University Guri Hospital
City
Gyeonggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Academic Medical Centre
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
North Shore Hospital (Waitemata District Health Board)
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Christchurch Hospital (Canterbury District Health Board)
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Southern District Health Board
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Endoskopia Sp. z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Lexmedica
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Federal State Budgetary Institution "State Scientific Centre of Coloproctology
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
LLC Novosibirskiy Gastrocenter
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Federal State Budgetary Scientific Institution "Scientific Research Institute of Physiology
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Centre Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy, Clinic for Gastroenterology and Hepatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
General Hospital "Djordje Joanovic"
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
Medak s.r.o.
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Facility Name
KM Management spol. s.r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Gastro I., s.r.o., Gastroenterologicka ambulancia
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Kingsbury Hospital
City
Claremont
State/Province
Cape Town
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Wits Clinical Research (WCR) Bara Site, Chris Hani Baragwanath Academic Hospital
City
Soweto
State/Province
Johannesburg, Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Chris Hani Baragwanath Academic Hospital
City
Soweto
State/Province
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Endocare Research Centre
City
Paarl
State/Province
Western CAPE
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Panorama Mediclinic
City
Panorama
State/Province
Western CAPE
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Clinical Hospital" Surgery Departm
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Kyiv Municipal Clinical Hospital #18
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
MI Uzhgorod Regional Hospital
City
Uzhgorod
ZIP/Postal Code
88009
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8HW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
35648151
Citation
Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=A3921288
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission

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