A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
Purpose
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.
Condition
- Ulcerative Colitis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CP-690,550 5 mg |
CP-690,550 5 mg tablet by mouth twice a day (BID) |
|
|
Experimental CP-690,550 10 mg |
CP-690,550 10 mg BID |
|
More Details
- Status
- Terminated
- Sponsor
- Pfizer