A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
Status: | Recruiting |
---|---|
Conditions: | Colitis, Colitis, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/24/2019 |
Start Date: | November 16, 2017 |
End Date: | November 22, 2022 |
Contact: | Pfizer CT.gov Call Center |
Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
Phone: | 1-800-718-1021 |
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.
designed to evaluate flexible dosing of CP-690,550.
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
We found this trial at
34
sites
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