A Study to Evaluate both the Efficacy and Safety Profile of CP-690,550 in Patients with Moderately to Severely Active Ulcerative Colitis
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 12-000546
NCT ID: NCT01458951
Sponsor Protocol Number: A3921095
About this study
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Subject must be at least 18 years of age.
- Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
- Subjects with moderately to severely active UC based on Mayo score criteria.
- Subjects must have failed or be intolerant of at least one of the following treatments for UC:
- Corticosteroids (oral or intravenous).
- Azathioprine or 6 mercaptopurine (6 MP).
- Anti TNF therapy.
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
- Subjects with disease limited to distal 15 cm.
- Subjects without previous treatment for UC (ie, treatment naïve).
- Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Edward Loftus, M.D.
Contact us for the latest status