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A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Phase 2
Completed
Conditions
Crohn's Disease
Registration Number
NCT00055523
Lead Sponsor
Abbott
Brief Summary

Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
300
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
(achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.
comparison of the induction of clinical remission
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (43)

Clinical Pharmacology Study Group

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Worcester, Massachusetts, United States

Mayo Clinic and Mayo Foundation

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Rochester, Minnesota, United States

Northwest Gastroenterology

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Bellevue, Washington, United States

Tacoma Digestive Disease Center

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Tacoma, Washington, United States

Shafran Gastroenterology Center

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Winter Park, Florida, United States

Wake Research Associates

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Raleigh, North Carolina, United States

Digestive Disorders Associates

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Annapolis, Maryland, United States

Rochester Institute for Digestive Diseases

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Rochester, New York, United States

University of Chicago

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Chicago, Illinois, United States

Long Beach Gastroenterology Assoc.

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Long Beach, California, United States

Gastroenterology and Hepatology

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Kansas City, Missouri, United States

Glenn Gordon, MD

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Mexico, Missouri, United States

Digestive Health Specialists

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Winston-Salem, North Carolina, United States

Northwest Gastroenterologists, S.C.

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Arlington Heights, Illinois, United States

Charlotte Gastroenterology and Hepatology

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Charlotte, North Carolina, United States

Altoona Center for Clinical Research

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Duncansville, Pennsylvania, United States

Wisconsin Center for Advanced Research

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Milwaukee, Wisconsin, United States

Inland Empire Gastroenterology

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Spokane, Washington, United States

Research Solutions

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Tulsa, Oklahoma, United States

Atlanta Gastroenterology Assoc.

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Atlanta, Georgia, United States

Brigham and Women's Hospital

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Boston, Massachusetts, United States

Peter Molloy, MD

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Pittsburgh, Pennsylvania, United States

Gastroenterology Associates of the East Bay

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Berkeley, California, United States

Cleveland Clinic Florida

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Weston, Florida, United States

Southeastern Digestive & Liver Disease

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Savannah, Georgia, United States

Massachusetts General Hospital

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Boston, Massachusetts, United States

NY Center for Clinical Research

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Lake Success, New York, United States

Long Island Clinical Research Associates

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Great Neck, New York, United States

Daniel Present

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New York, New York, United States

UNC School of Medicine

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Chapel Hill, North Carolina, United States

Carolina Research Associates

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Charlotte, North Carolina, United States

Charlottesville Medical Research

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Charlottesville, Virginia, United States

Sharp Rees-Stealy Medical Group

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San Diego, California, United States

Consultants for Clinical Research

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Cincinnati, Ohio, United States

Oklahoma Foundation for Digestive Disease

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Oklahoma City, Oklahoma, United States

Nashville Medical Research Institute

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Nashville, Tennessee, United States

LSU School of Medicine

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New Orleans, Louisiana, United States

New York Presbyterian Hospital

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New York, New York, United States

Deaconess Billings Clinic Research Division

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Billings, Montana, United States

Gastroenterology Assoc. of Fairfield Co.

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Bridgeport, Connecticut, United States

Drug Research Services, Inc.

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Metairie, Louisiana, United States

Gastroenterology Specialties, P.C.

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Lincoln, Nebraska, United States

Diseases of the Digestive System

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Chattanooga, Tennessee, United States

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