Summary

for people ages 4-17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Melvin Heyman

Description

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).

Official Title

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

Keywords

Ulcerative Colitis (UC) Ulcerative Colitis adalimumab Colitis Ulcer Colitis, Ulcerative Adalimumab Dose A Adalimumab Dose B

Eligibility

You can join if…

Open to people ages 4-17

  • 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.

You CAN'T join if...

  • 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).

Locations

  • Univ California, San Francisco /ID# 120901 accepting new patients
    San Francisco California 94143-2204 United States
  • Childrens Hospital LA /ID# 147452 completed
    Los Angeles California 90027 United States

Lead Scientist

  • Melvin Heyman
    Professor, Pediatrics. Authored (or co-authored) 139 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
http://rxabbvie.com/
ID
NCT02065557
Phase
Phase 3
Study Type
Interventional
Last Updated