Status:
TERMINATED
A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
Lead Sponsor:
Pfizer
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03281304
Start Date
November 16 2017
End Date
March 18 2022
Last Update
March 21 2023
Active Locations (80)
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1
Surgicare of Mobile
Mobile, Alabama, United States, 36606
2
Alabama Medical Group, P.C.
Mobile, Alabama, United States, 36608
3
Clinical Applications Laboratories, Inc.
San Diego, California, United States, 92103
4
Bristol Hospital
Bristol, Connecticut, United States, 06010