A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
NCT03281304
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- 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.
- 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
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Descriptive Information | |||||||
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Brief Title ICMJE | A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission | ||||||
Official Title ICMJE | 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 | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | Ulcerative Colitis | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE | 141 | ||||||
Original Estimated Enrollment ICMJE | 130 | ||||||
Estimated Study Completion Date ICMJE | March 8, 2023 | ||||||
Actual Primary Completion Date | February 14, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03281304 | ||||||
Other Study ID Numbers ICMJE | A3921288 RIVETING STUDY ( Other Identifier: Alias Study Number ) 2017-002274-39 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |