Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis (UC)

In brief

To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

Key facts

Study ID

NCT02065622

Run by

AbbVie

People needed

952

Starts

2014-03-27

Expected to finish

2019-11-11

Last updated by the study team

2020-11-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period.
• Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent or prior treatment with a full and adequate course, in the opinion of the Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is confirmed by central reader.

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

• Ucsd /Id# 122313 — La Jolla, California, United States
• Rocky Mountain Clinical Resear /ID# 122180 — Wheat Ridge, Colorado, United States
• Medical Research Ctr CT /ID# 122179 — Hamden, Connecticut, United States
• Gastro Florida /ID# 170619 — Clearwater, Florida, United States
• Research Associates of South Florida,LLC /ID# 170309 — Miami, Florida, United States
• Gastroenterology Group Naples /ID# 127806 — Naples, Florida, United States
• Shafran Gastroenterology Ctr /ID# 122320 — Winter Park, Florida, United States
• Atlanta Gastro Assoc /ID# 122336 — Atlanta, Georgia, United States
• Gastro Assoc of Central GA /ID# 122318 — Macon, Georgia, United States
• Northwestern University Feinberg School of Medicine /ID# 122183 — Chicago, Illinois, United States
• University of Chicago /ID# 122302 — Chicago, Illinois, United States
• Carle Foundation Hospital /ID# 135955 — Urbana, Illinois, United States
• Louisiana Research Ctr. LLC /ID# 141655 — Shreveport, Louisiana, United States
• University of Maryland Med Ctr /ID# 169734 — Baltimore, Maryland, United States
• MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238 — Chevy Chase, Maryland, United States
• University of Michigan Hospitals /ID# 122240 — Ann Arbor, Michigan, United States
• Mayo Clinic - Rochester /ID# 122244 — Rochester, Minnesota, United States
• Ctr for Digest and Liver Dis /ID# 122182 — Mexico, Missouri, United States
• NYU Langone Long Island CRA /ID# 122177 — Great Neck, New York, United States
• Icahn School of Med Mt. Sinai /ID# 127047 — New York, New York, United States
• Charlotte Gastro Hepatology /ID# 122235 — Charlotte, North Carolina, United States
• Wake Research Associates, LLC /ID# 122157 — Raleigh, North Carolina, United States
• Consultants for Clinical Res /ID# 122304 — Cincinnati, Ohio, United States
• Dayton Gastroenterology, Inc. /ID# 127804 — Englewood, Ohio, United States
• Digestive Health Specialists of the Southeast /ID# 127844 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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