Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.

Key facts

Study ID

NCT02065570

Run by

AbbVie

People needed

514

Starts

2014-05-01

Expected to finish

2020-01-30

Last updated by the study team

2021-02-18

Who can join

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

You may qualify if…

• Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period.
• Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral corticosteroids and/or immunosuppressants.
• Mucosal ulceration on endoscopy.

You may not qualify if…

• Subject with ulcerative colitis or indeterminate colitis.
• Subject who has had surgical bowel resections in the past 6 months or is planning resection.
• Subjects with an ostomy or ileoanal pouch.
• Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
• Subject who has short bowel syndrome.
• Chronic recurring infections or active Tuberculosis (TB).

Where it is running

• Digestive Health Specialists of the Southeast /ID# 122483 — Dothan, Alabama, United States
• Moore UC San Diego Cancer Center /ID# 119053 — La Jolla, California, United States
• Axis Clinical Trials /ID# 130390 — Los Angeles, California, United States
• Rocky Mountain Gastroenterology /ID# 119038 — Wheat Ridge, Colorado, United States
• Medical Research Ctr CT /ID# 119037 — Hamden, Connecticut, United States
• Gastroenterology Group Naples /ID# 122493 — Naples, Florida, United States
• Internal Med Specialists /ID# 137737 — Orlando, Florida, United States
• Shafran Gastroenterology Ctr /ID# 119057 — Winter Park, Florida, United States
• Winship Cancer Institute of Emory University /ID# 136851 — Atlanta, Georgia, United States
• Atlanta Gastro Assoc /ID# 119065 — Atlanta, Georgia, United States
• Gastroenterology Associates of Central Georgia, LLC /ID# 119056 — Macon, Georgia, United States
• Northwestern University Feinberg School of Medicine /ID# 119043 — Chicago, Illinois, United States
• University of Chicago DCAM /ID# 119077 — Chicago, Illinois, United States
• Carle Foundation Hospital Digestive Health Research Center /ID# 136008 — Urbana, Illinois, United States
• Louisana Research Center, LLC /ID# 136749 — Shreveport, Louisiana, United States
• Investigative Clinical Research /ID# 119033 — Annapolis, Maryland, United States
• MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 119042 — Chevy Chase, Maryland, United States
• Commonwealth Clinical Studies /ID# 136850 — Brockton, Massachusetts, United States
• University of Michigan Health Systems /ID# 119076 — Ann Arbor, Michigan, United States
• Minnesota Gastroenterology, P. A. /ID# 137280 — Plymouth, Minnesota, United States
• Mayo Clinic /ID# 122489 — Rochester, Minnesota, United States
• Kansas City Research Institute /ID# 119034 — Kansas City, Missouri, United States
• Ctr for Digest and Liver Dis /ID# 119040 — Mexico, Missouri, United States
• Albany Medical College /ID# 140200 — Albany, New York, United States
• Birmingham Gastroenterology Associates O.C /ID# 137282 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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