Ulcerative Colitis Medication Research Study
Researchers at the University of Michigan are testing the efficacy and safety of an investigational treatment for people with ulcerative colitis.
Fast Facts
Ages 16-75
Diagnosed with Ulcerative Colitis After an Endoscopy
Compensation Provided
Conducted in Ann Arbor, MI
Ages 16-80
Diagnosed with Ulcerative Colitis After an Endoscopy
Compensation Provided
Conducted in Ann Arbor, MI
Study Background
Researchers at University of Michigan want to understand the efficacy and safety of a trial drug for patients with ulcerative colitis.
Inflammatory Bowel Disease (IBD) is a chronic condition causing digestive tract inflammation, with symptoms like abdominal pain, diarrhea, and fatigue. Ulcerative colitis is a specific type of IBD that causes inflammation and ulcers in the intestines, colon, and rectum. Symptoms can present differently from one patient to another, causing pain and complications throughout the lifespan.
Our team aims to test the efficacy and safety of an experimental drug, meaning one that is not yet approved by the Food and Drug Administration (FDA). This drug is intended for people with moderate to severe active ulcerative colitis. If you’re interested in participating, you’ll be screened for eligibility, and take the drug for up to 4 years for your ulcerative colitis symptoms.
Join our compensated study today!
Study Background
Researchers at University of Michigan want to understand the efficacy and safety of a trial drug for patients with ulcerative colitis.
Inflammatory Bowel Disease (IBD) is a chronic condition causing digestive tract inflammation, with symptoms like abdominal pain, diarrhea, and fatigue. Ulcerative colitis is a specific type of IBD that causes inflammation and ulcers in the intestines, colon, and rectum. Symptoms can present differently from one patient to another, causing pain and complications throughout the lifespan.
Our team aims to test the efficacy and safety of an experimental drug, meaning one that is not yet approved by the Food and Drug Administration (FDA). This drug is intended for people with moderate to severe active ulcerative colitis. If you’re interested in participating, you’ll be screened for eligibility, and take the drug for up to 4 years for your ulcerative colitis symptoms.
Join our compensated study today!
Additional Information
This study is being done to assess the safety and efficacy of an experimental ulcerative colitis treatment when compared with a placebo. Researchers aim to improve options for ulcerative colitis treatment.
You may qualify for a study if you meet the following criteria.
Inclusion Criteria:
- Ages 16-75
- Diagnosed with Ulcerative Colitis at least 3 months ago
- Diagnosis occurred following an endoscopy
Exclusion Criteria:
- History of major surgery removing part of the intestines or colon.
- Currently pregnant or breastfeeding, or planning to become pregnant in the next 12 months
- Recipient of a transplant organ
- Diagnosed with Crohn’s Disease
If you participate in this study, there will be a series of stages to the participation. Visits will include collecting information about your health history, symptoms, and some testing like a blood test, endoscopy, and others. The stages of the trial are below:
- Screening: First, the trial staff will see if you can be in the trial. This is called the screening phase and will last about 6 weeks. During this time, you will visit the site one or more times.
- Induction Period: If you can be in the trial, the next step is the 3-month Induction Period. During the Induction Period, you will visit the site about 5 times.
- Maintenance Period: After the Induction Period, the next step is the Maintenance Period. You will be in the Maintenance Period for up to 9 months and have about 7 scheduled visits. The trial doctor or trial staff will also contact you between some visits.
- Reinduction Period: If you go into the Reinduction Period, you will visit the trial site about 5 times over 3 months. Any previously scheduled Maintenance Period trial treatments and visits will end.
- Extension Period:
- If you go into the Extension Period, you may be in the trial up to 3 more years.
During the first year of the Extension Period, you will visit the trial site about:
- 4 weeks after the first shot (Week 4)
- Then about 8 weeks later (Week 12)
- Then about every 12 weeks (Week 24 and Week 36)
- Then 14 weeks later (Week 50)
- Then 2 weeks later (Week 52)
The extension period in this trial may continue for an additional two years. During the second and third years of the Extension Period, you will then visit the trial site about every 12 weeks. Other long-term treatment options may be available. The trial doctor can tell you more about this.
- Follow-up Period: You will be in the Follow-up Period about 14 weeks and will visit the trial site or be contacted by telephone about 3 times.
As a note: If your UC seems to be getting worse, you may need to visit the trial site between scheduled visits so that the trial doctor and staff can monitor your health. Throughout the trial treatment and follow-up periods, the trial doctor or trial staff may contact you by telephone or other approved technology to check on your health. It is important that you talk to the trial doctor or trial staff if they contact you.
As a participant, you can receive up to $4925 for your time and effort.
There is no cost for you to participate in our research study.
