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

Stopped early · Phase 4

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT03281304

Run by

Pfizer

People needed

140

Starts

2017-11-16

Expected to finish

2022-03-18

Last updated by the study team

2023-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Alabama Medical Group, P.C. — Mobile, Alabama, United States
• Clinical Applications Laboratories, Inc. — San Diego, California, United States
• Bristol Hospital — Bristol, Connecticut, United States
• Connecticut Clinical Research Institute — Bristol, Connecticut, United States
• Central Connecticut Endoscopy Center — Plainville, Connecticut, United States
• Advanced Medical Research Center — Port Orange, Florida, United States
• Florida Medical Clinic, P.A. — Zephyrhills, Florida, United States
• Cotton-O'Neil Clinical Research Center, Digestive Health — Topeka, Kansas, United States
• Chevy Chase Endoscopy Center — Chevy Chase, Maryland, United States
• MGG Group Co., Inc., Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
• Eastside Endoscopy Center — Macomb, Michigan, United States
• Clinical Research Institute of Michigan, LLC — Troy, Michigan, United States
• NYU Langone Long Island Clinical Research Associates — Lake Success, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Columbia University Medical Center Research Pharmacy/ Milstein Hospital — New York, New York, United States
• Great Lakes Gastroenterology Research, LLC — Mentor, Ohio, United States
• Memorial Hermann Hospital — Houston, Texas, United States
• The University of Texas Health Science Center at Houston (UTHealth)- McGovern Medical School — Houston, Texas, United States
• Christus Trinity Mother Frances Endoscopy Center — Tyler, Texas, United States
• Tyler Research Institute, LLC — Tyler, Texas, United States
• Alpine Medical Group — Salt Lake City, Utah, United States
• Wasatch Clinical Research, LLC — Salt Lake City, Utah, United States
• UZ Leuven (University Hospital Leuven), Campus Gasthuisberg — Leuven, Belgium
• Surgicare of Mobile — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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