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

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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).

Key facts

Study ID

NCT02065557

Run by

AbbVie

People needed

101

Starts

2014-10-13

Expected to finish

2020-02-07

Last updated by the study team

2020-10-05

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify 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).

Where it is running

• Univ California, San Francisco /ID# 120901 — San Francisco, California, United States
• Arnold Palmer Hosp Children /ID# 120898 — Orlando, Florida, United States
• Emory University Hospital /ID# 121858 — Atlanta, Georgia, United States
• Children's Ctr Digestive, US /ID# 121855 — Atlanta, Georgia, United States
• University of Chicago /ID# 120904 — Chicago, Illinois, United States
• Loyola University Medical Ctr /ID# 120900 — Maywood, Illinois, United States
• Indiana University /ID# 120908 — Indianapolis, Indiana, United States
• Massachusetts General Hospital /ID# 124551 — Boston, Massachusetts, United States
• Boston Childrens Hospital /ID# 147714 — Boston, Massachusetts, United States
• Mayo Clinic - Rochester /ID# 121056 — Rochester, Minnesota, United States
• Minnesota Gastroenterology P.A /ID# 120895 — Saint Paul, Minnesota, United States
• Goryeb Chidlren's Hospital /ID# 121860 — Morristown, New Jersey, United States
• North Shore University Hospital /ID# 120905 — New Hyde Park, New York, United States
• Univ Rochester Med Ctr /ID# 127776 — Rochester, New York, United States
• Multicare Institute for Research and Innovation /ID# 147716 — Tacoma, Washington, United States
• Womens and Childrens Hospital /ID# 127538 — Adelaide, South Australia, Australia
• Medizinische Universitat Wien /ID# 120802 — Vienna, State of Vienna, Austria
• LKH Salzburg and Paracelsus /ID# 123457 — Salzburg, Austria
• UZ Brussel /ID# 120798 — Jette, Brussels Capital, Belgium
• Cliniques Universitaires Saint Luc /ID# 120797 — Woluwe-Saint-Lambert, Brussels Capital, Belgium
• Hosp Univ Enfants Reine Fabiol /ID# 120795 — Brussels, Belgium
• London Health Sciences Centre /ID# 127777 — London, Ontario, Canada
• Palacky University /ID# 131388 — Olomouc, Czechia
• Univ Hosp, Plzen, CZ /ID# 120813 — Pilsen, Czechia
• Childrens Hospital LA /ID# 147452 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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