Study Details
Testing the Drug Combination Vedolizumab and Tofacitinib in Adults with Moderate to Severe Active Ulcerative Colitis
(IRB#: IRB_00184868)
Ulcerative Colitis (UC) can cause severe pain and swelling in the lining of the colon and rectum. This study will test combining previously approved UC drugs Vedolizumab with Tofacitinib to treat adults with this disease. The study wants to see if the drug combination will help people with the disease and is safe. People in this study will receive the combination treatment. After the combination treatment people may be eligible to continue receiving Vedolizumab. If not, study participation will end. Being in the study requires attending about 13 in person visits at the study clinic. Study participation lasts up to 1.5 years. Medical tests will be done during the study to track the health of participants.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- 18 to 65 years old
- Diagnosis of Ulcerative Colitis at least 3 months before participation
- Moderate to severe active Ulcerative Colitis
- Family history of colorectal cancer, personal history of colorectal cancer risk
- Must use specific birth control during the study and 18 weeks after the last dose of study treatment
Exclusion Criteria
- Specific severe Ulcerative Colitis related conditions
- Active infection or any unstable or uncontrolled disease
- Received any other study product 60 days before participation
- Moderate to severe heart failure 6 months before participation
- History of specific cancer
Will I be paid for my time?
Yes
IRB#: IRB_00184868
PI: John Valentine
Department: GASTROENTEROLOGY
Approval Date: 2025-04-17 06:00:00
Specialties: Gastroenterology
I am Interested