Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

  • Therapeutic
  • Recruiting
  • NCT02065557
Eligibility Details Visit Clinicaltrials.gov

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

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).

Gender
All

Age Group
4 Years to 17 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - 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.

        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).

At a Glance

National Government IDNCT02065557

IRB#IRB14-0363

Lead SponsorAbbVie

Lead PhysicianRanjana Gokhale

Collaborator(s)N/A

EligibilityAll
4 Years to 17 Years
Recruiting