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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00055523
First received: March 4, 2003
Last updated: August 11, 2006
Last verified: August 2006
  Purpose

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)


Condition Intervention Phase
Crohn's Disease
Drug: Adalimumab (D2E7)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • comparison of the induction of clinical remission
  • (achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.

Estimated Enrollment: 300
Study Start Date: April 2002
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Diagnosis of Crohn's disease
  • CDAI score at baseline of between 220 and 450
  • Normal laboratory parameters
  • Willing and able to give informed consent

Exclusion:

  • Diagnosis of ulcerative colitis
  • Women cannot be pregnant or breastfeeding
  • No previous use of infliximab or other anti-TNF antagonists
  • No previous history of tuberculosis or listeria infection
  • No previous history of cancer other than successfully treated skin cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055523

  Hide Study Locations
Locations
United States, California
Gastroenterology Associates of the East Bay
Berkeley, California, United States, 94705
Long Beach Gastroenterology Assoc.
Long Beach, California, United States, 90806
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92123
United States, Connecticut
Gastroenterology Assoc. of Fairfield Co.
Bridgeport, Connecticut, United States, 06606
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta Gastroenterology Assoc.
Atlanta, Georgia, United States, 30342
Southeastern Digestive & Liver Disease
Savannah, Georgia, United States, 31404
United States, Illinois
Northwest Gastroenterologists, S.C.
Arlington Heights, Illinois, United States, 600005
University of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
Drug Research Services, Inc.
Metairie, Louisiana, United States, 70001
LSU School of Medicine
New Orleans, Louisiana, United States, 70115
United States, Maryland
Digestive Disorders Associates
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 002115
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, Minnesota
Mayo Clinic and Mayo Foundation
Rochester, Minnesota, United States, 55905
United States, Missouri
Gastroenterology and Hepatology
Kansas City, Missouri, United States, 64131
Glenn Gordon, MD
Mexico, Missouri, United States, 65265
United States, Montana
Deaconess Billings Clinic Research Division
Billings, Montana, United States, 59101
United States, Nebraska
Gastroenterology Specialties, P.C.
Lincoln, Nebraska, United States, 68503
United States, New York
Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
NY Center for Clinical Research
Lake Success, New York, United States, 11042
New York Presbyterian Hospital
New York, New York, United States, 10021
Daniel Present
New York, New York, United States, 10029
Rochester Institute for Digestive Diseases
Rochester, New York, United States, 14607
United States, North Carolina
UNC School of Medicine
Chapel Hill, North Carolina, United States, 27599
Carolina Research Associates
Charlotte, North Carolina, United States, 28262
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, United States, 28207
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Digestive Health Specialists
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Oklahoma Foundation for Digestive Disease
Oklahoma City, Oklahoma, United States, 73104
Research Solutions
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Peter Molloy, MD
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Diseases of the Digestive System
Chattanooga, Tennessee, United States, 37421
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37205
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22902
United States, Washington
Northwest Gastroenterology
Bellevue, Washington, United States, 98004
Inland Empire Gastroenterology
Spokane, Washington, United States, 99204
Tacoma Digestive Disease Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53702
Sponsors and Collaborators
Abbott
Investigators
Principal Investigator: Stephen B Hanauer, MD University of Chicago Department of Medicine
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00055523     History of Changes
Other Study ID Numbers: M02-403
Study First Received: March 4, 2003
Last Updated: August 11, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014