Summary
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).
Conditions
Ulcerative Colitis
Recruitment Status
Completed
Eligibility Criteria
Inclusion Criteria:
Diagnosis of 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.
Exclusion Criteria:
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).
Intervention
Intervention Type
Intervention Name
Biological
Adalimumab
Biological
Placebo
Phase
Phase 3
Gender
All
Min Age
4 Years
Max Age
17 Years
Download Date
October 5, 2020
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: