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

February 21, 2023 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre - University Hospital
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
  • Czechia
      • Strakonice, Czechia, 386 01
        • Nemocnice Strakonice a.s.
  • France
      • Nantes, France, 44093
        • Chu Hotel Dieu
      • Pessac, France, 33600
        • CHU de Bordeaux Hôpital Haut Lévêque
  • Germany
      • Kiel, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein
  • Hungary
      • Budapest, Hungary, 1125
        • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
      • Budapest, Hungary, 1136
        • Pannonia Maganorvosi Centrum Kft.
      • Gyula, Hungary, 5700
        • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Endoszkopos Laboratorium
  • Italy
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • Università "Magna Graecia" di Catanzaro
  • Japan
      • Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Osaka, Japan, 545-8586
        • Osaka Metropolitan University Hospital
      • Tokyo, Japan, 160-8582
        • Keio University Hospital
    • Aichi
      • Nagakute, Aichi, Japan, 480-1195
        • Aichi Medical University Hospital
    • Fukuoka
      • Chikushino, Fukuoka, Japan, 818-8502
        • Fukuoka University Chikushi Hospital
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
    • Osaka
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital
    • Shiga
      • Otsu, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Tokyo Medical and Dental University Hospital, Faculty of Medicine
      • Hachioji, Tokyo, Japan, 192-0032
        • Tokai University Hachioji Hospital
      • Minato-ku, Tokyo, Japan, 108-8642
        • Kitasato University Kitasato Institute Hospital
      • Shinagawa-ku, Tokyo, Japan, 142-8666
        • Showa University Hospital
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 11923
        • Hanyang University Guri Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 02447
        • Kyung Hee University Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Centre
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital (Canterbury District Health Board)
      • Dunedin, New Zealand, 9016
        • Southern District Health Board
    • Auckland
      • Takapuna, Auckland, New Zealand, 0620
        • North Shore Hospital (Waitemata District Health Board)
  • Poland
      • Sopot, Poland, 81-756
        • Endoskopia Sp. z o.o.
      • Wroclaw, Poland, 53-114
        • LexMedica
  • Russian Federation
      • Moscow, Russian Federation, 123423
        • Federal State Budgetary Institution "State Scientific Centre of Coloproctology
      • Novosibirsk, Russian Federation, 630007
        • LLC Novosibirskiy Gastrocenter
      • Novosibirsk, Russian Federation, 630117
        • Federal State Budgetary Scientific Institution "Scientific Research Institute of Physiology
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
      • Belgrade, Serbia, 11000
        • Clinical Hospital Centre Zvezdara
      • Belgrade, Serbia, 11000
        • Military Medical Academy, Clinic for Gastroenterology and Hepatology
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac
      • Zrenjanin, Serbia, 23000
        • General Hospital "Djordje Joanovic"
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • Medak s.r.o.
      • Nitra, Slovakia, 949 01
        • KM Management spol. s.r.o.
      • Presov, Slovakia, 080 01
        • Gastro I., s.r.o., Gastroenterologicka ambulancia
  • South Africa
    • Cape Town
      • Claremont, Cape Town, South Africa, 7708
        • Kingsbury Hospital
    • Johannesburg
      • Soweto, Johannesburg, South Africa, 2013
        • Chris Hani Baragwanath Academic Hospital
    • Johannesburg, Gauteng
      • Soweto, Johannesburg, Gauteng, South Africa, 2013
        • Wits Clinical Research (WCR) Bara Site, Chris Hani Baragwanath Academic Hospital
    • Western CAPE
      • Paarl, Western CAPE, South Africa, 7646
        • Endocare Research Centre
      • Panorama, Western CAPE, South Africa, 7500
        • Panorama MediClinic
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
  • Ukraine
      • Chernivtsi, Ukraine, 58001
        • Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Clinical Hospital" Surgery Departm
      • Kyiv, Ukraine, 01030
        • Kyiv Municipal Clinical Hospital #18
      • Uzhgorod, Ukraine, 88009
        • MI Uzhgorod Regional Hospital
      • Vinnytsia, Ukraine, 21005
        • Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2
  • United Kingdom
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8HW
        • University Hospitals Bristol NHS Foundation Trust
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36606
        • Surgicare of Mobile
      • Mobile, Alabama, United States, 36608
        • Alabama Medical Group, P.C.
    • California
      • San Diego, California, United States, 92103
        • Clinical Applications Laboratories, Inc.
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Connecticut Clinical Research Institute
      • Bristol, Connecticut, United States, 06010
        • Bristol Hospital
      • Plainville, Connecticut, United States, 06062
        • Central Connecticut Endoscopy Center
    • Florida
      • Port Orange, Florida, United States, 32127
        • Advanced Medical Research Center
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, P.A.
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center, Digestive Health
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • MGG Group Co., Inc., Chevy Chase Clinical Research
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Endoscopy Center
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
      • Macomb, Michigan, United States, 48044
        • Eastside Endoscopy Center
      • Troy, Michigan, United States, 48098
        • Clinical Research Institute of Michigan, LLC
    • New York
      • Lake Success, New York, United States, 11042
        • NYU Langone Long Island Clinical Research Associates
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center Research Pharmacy/ Milstein Hospital
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston (UTHealth)- McGovern Medical School
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute, LLC
      • Tyler, Texas, United States, 75701
        • Christus Trinity Mother Frances Endoscopy Center
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Alpine Medical Group
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CP-690,550 5 mg
CP-690,550 5 mg tablet by mouth twice a day (BID)
Drug: CP-690,500 5 mg
CP-690,550 5 mg tablet BID
Experimental: CP-690,550 10 mg
CP-690,550 10 mg BID
Drug: CP-690,550 10 mg
CP-690,550 10 mg tablet BID

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Remission Based on Modified Mayo Score at Month 6
Time Frame: 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.
Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6
Time Frame: Baseline, 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.
Baseline, Months 1, 3 and 6
Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method
Time Frame: Up to Month 42
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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Months 18, 30 and 42
Change From Baseline in Modified Mayo Score at Month 6
Time Frame: Baseline, 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.
Baseline, Month 6
Change From Baseline in Modified Mayo Score at Months 18, 30 and 42
Time Frame: Baseline, 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.
Baseline, Months 18, 30 and 42
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Time Frame: Baseline, 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.
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
Time Frame: Baseline, 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.
Baseline, Month 6
Change From Baseline in Total Mayo Score at Months 18, 30 and 42
Time Frame: Baseline, 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.
Baseline, Months 18, 30 and 42
Change From Baseline in Partial Mayo Score at Months 1, 3 and 6
Time Frame: Baseline, 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.
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
Time Frame: Baseline, 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.
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
Time Frame: 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.
Months 6, 18, 30 and 42
Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42
Time Frame: 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.
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
Time Frame: Baseline, 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.
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
Time Frame: Baseline, 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.
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)
Time Frame: Baseline up to 43 months
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).
Baseline up to 43 months
Number of Participants With Serious Infections
Time Frame: Baseline up to 43 months
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.
Baseline up to 43 months
Number of Participants With Clinical Laboratory Abnormalities
Time Frame: Baseline up to 27 months
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.
Baseline up to 27 months
Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation
Time Frame: Baseline up to 43 months
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).
Baseline up to 43 months
Number of Participants With Vital Sign Abnormalities
Time Frame: Baseline up to 43 months
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.
Baseline up to 43 months
Number of Participants With Clinically Significant Physical Examinations Abnormalities
Time Frame: Baseline up to 43 months
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.
Baseline up to 43 months
Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee
Time Frame: Baseline up to 43 months
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.
Baseline up to 43 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3921288
  • RIVETING STUDY (Other Identifier: Alias Study Number)
  • 2017-002274-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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