Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Tab Title Description
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.
- Rochester, Minnesota: 13-009390
NCT ID: NCT02065557
Sponsor Protocol Number: M11-290
About this study
The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Diagnosis of Ulcerative Colitis (UC) for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy.
- Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.
- Subject with Crohn's disease (CD) or indeterminate colitis (IC).
- Current diagnosis of fulminant colitis and/or toxic megacolon.
- Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
- Chronic recurring infections or active Tuberculosis (TB).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
William Faubion, M.D.
Closed for enrollment
Publications are currently not available