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
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.
Inclusion Criteria:
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:
New York, New York 10032, United States
Houston, Texas 77030, United States
Takatsuki-shi, Osaka 569-8686, Japan
Bunkyo-ku, Tokyo 113-8519, Japan
Minato-ku, Tokyo 108-8642, Japan
Shinagawa-ku, Tokyo 142-8666, Japan
Moscow, 123423, Russia
Novosibirsk, 630117, Russia
Soweto, Johannesburg, Gauteng 2013, South Africa
Panorama, Western Cape 7500, South Africa
Chernivtsi, 58001, Ukraine
Vinnytsia, 21005, Ukraine