A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission

• Status: Active, not recruiting
• Trial end date: 2023-03-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Tofacitinib

Criteria

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