Study Details
Testing the Drug Vedolizumab Intravenous plus Adalimumab Subcutaneous or Ustekinumab in Adults with Moderate to Severe Crohn's Disease
(IRB#: IRB_00184866)
Crohns disease (CD) can cause severe pain and swelling in the digestive tract of the stomach. This study will test combining the different approved CD drugs Vedolizumab Intravenous plus Adalimumab Subcutaneous or Ustekinumab to treat adults with this disease. The study wants to see if the combination of drugs will help people with the disease and is safe. People in this study will receive one of the combination treatments depending on the treatment received from previous routine medical care before participating in the study. After the combination treatment is given people will receive only Vedolizumab. Once all treatments are complete there will be a follow-up period. Being in the study requires attending in person visits at the study clinic and lasts about 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 Crohns disease
- Moderate to severe active Crohns disease
- Received at least one study specific approved treatment for Crohns disease with specific reaction to the treatment
- Able to attend in person visits at the study clinic
Exclusion Criteria
- Current diagnosis of ulcerative colitis or indeterminate colitis
- Current or history of abdominal abscess
- Active infection or any unstable or uncontrolled disease
- Previous organ transplant
- History of heart failure
Will I be paid for my time?
Yes
IRB#: IRB_00184866
PI: John Valentine
Department: GASTROENTEROLOGY
Approval Date: 2025-04-17 06:00:00
Specialties: Gastroenterology
I am Interested