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Summary

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

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, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

Keywords

Ulcerative Colitis adalimumab Colitis Ulcer Colitis, Ulcerative

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

  • University of California, San Francisco /ID# 120901 accepting new patients
    San Francisco, California, 94158, United States
  • Childrens Hospital Los Angeles (USC) /ID# 147452 accepting new patients
    Los Angeles, California, 90027, United States
  • Clinical and Translational Research Center at UCLA /ID# 120909 withdrawn
    Los Angeles, California, 90095, United States
  • Children's Hospital of Orange County /ID# 120903 withdrawn
    Orange, California, 92868, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
http://rxabbvie.com/
ID
NCT02065557
Phase
Phase 3
Lead Scientist
Melvin Heyman
Study Type
Interventional
Last Updated
October 25, 2017
I’m interested in this study!