Clinical Trial TitleA long-term non-interventional registry trial of Humira® (adalimumab) in patients with ulcerative colitis.
Clinical Trial Protocol Description:
The purpose of this registry study is to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active ulcerative colitis who are treated as recommended in the product label. Two groups of patients will be recruited:
- Group 1: Patients who are prescribed and treated with adalimumab.
- Group 2: Patients who are being prescribed and treated with immunomodulatory therapy.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are an adult patient with moderately to severely active ulcerative colitis who has been prescribed Humira (adalimumab) according to the local label and have been on Humira for at least eight weeks.
- Are an adult patient with moderately to severely active ulcerative colitis being prescribed and treated with IMM (6-mercaptopurine or azathioprine) for at least 12 weeks with no concurrent biologic use.
You will be excluded from the study if any of the following criteria apply to you:
- Have been on IMM therapy without a concurrent biologic if you cannot continue to be treated with IMM therapy.
- Are being treated with any investigational agents and/or approved biologics other than Humira.
This is a partial list of eligibility requirements.
Clinical Trial Investigator
Garth R. Swanson, MD, MS
RUSH University Medical Center
1620 W Harrison St
Chicago, IL 60612