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Crohn's Disease |
Crohn's disease; Crohn//'s disease; Inflamatory Bowel Disease; Inflammatory Bowel Disease, Crohn's |
Clinical Trial: Remission in Subjects with Crohn's Disease
This study has been completed.
|
Purpose
Purpose of the study is to test whether subjects who were previously in clinical remission in the M02-403 study can maintain their remission on adalimumab for a period of one year compared to placebo (an inactive substance).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Crohn's Disease | Drug: Adalimumab (D2E7) | Phase II |
MedlinePlus related topics: Crohn's Disease
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Continuation Study of the Human Anti-TNF Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects with Crohn's Disease
Further Study Details:
Study start: October 2002
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion:
- Subjects must have successfully completed the M02-403 to be eligible for this study
- Diagnosis of Crohn's disease
- 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
Location Information
California
Gastroenterology Associates of the East Bay, Berkeley, California, 94705, United States
Sharp Rees-Stealy Medical Group, San Diego, California, 92123, United States
Long Beach Gastroenterology Assoc., Long Beach, California, 90806, United States
Connecticut
Gastroenterology Assoc. of Fairfield Co., Bridgeport, Connecticut, 06606, United States
Florida
Wake Research Associates, Weston, Florida, 33331, United States
Cleveland Clinic Florida, Weston, Florida, 33331, United States
Shafran Gastroenterology Center, Winter Park, Florida, 32789, United States
Georgia
Southeastern Digestive & Liver Disease, Savannah, Georgia, 31404, United States
Atlanta Gastroenterology Assoc., Atlanta, Georgia, 30342, United States
Illinois
University of Chicago, Chicago, Illinois, 60637, United States
Northwest Gastroenterologists, S.C., Arlington Heights, Illinois, 60005, United States
Louisiana
LSU School of Medicine, New Orleans, Louisiana, 70115, United States
Drug Research Services, Inc., Metairie, Louisiana, 70001, United States
Maryland
Digestive Disorders Associates, Annapolis, Maryland, 21401, United States
Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
Clinical Pharmacology Study Group, Worchester, Massachusetts, 01610, United States
Minnesota
Mayo Clinic and Mayo Foundation, Rochester, Minnesota, 55905, United States
Missouri
Glenn Gordon, MD, Mexico, Missouri, 65265, United States
Montana
Deaconess Billings Clinic Research Division, Billings, Montana, 59101, United States
Nebraska
Gastroenterology Specialties, P.C., Lincoln, Nebraska, 68503, United States
New York
Daniel Present, New York, New York, 10029, United States
New York Presbyterian Hospital, New York, New York, 10021, United States
Rochester Institute for Digestive Diseases, Rochester, New York, 14607, United States
NY Center for Clinical Research, Lake Success, New York, 11042, United States
Long Island Clinical Research Associates, Great Neck, New York, 11021, United States
North Carolina
UNC School of Medicine, Chapel Hill, North Carolina, 27599, United States
Digestive Health Specialists, Winston Salem, North Carolina, 27103, United States
Charlotte Gastroenterology and Hepatology, Charlotte, North Carolina, 28207, United States
Ohio
Consultants for Clinical Research, Cincinnati, Ohio, 45219, United States
Oklahoma
Oklahoma Foundation for Digestive Disease, Oklahoma City, Oklahoma, 73104, United States
Research Solutions, Tulsa, Oklahoma, 74104, United States
Pennsylvania
Peter Molloy, MD, Pittsburgh, Pennsylvania, 15224, United States
Tennessee
Diseases of the Digestive System, Chattanooga, Tennessee, 37421, United States
Nashville Medical Research Institute, Nashville, Tennessee, 37205, United States
Virginia
Charlottesville Medical Research, Charlottesville, Virginia, 22902, United States
Washington
Inland Empire Gastroenterology, Spokane, Washington, 99204, United States
Tacoma Digestive Disease Center, Tacoma, Washington, 98405, United States
Northwest Gastroenterology, Bellevue, Washington, 98004, United States
Wisconsin
Wisconsin Center for Advanced Research, Milwaukee, Wisconsin, 53207, United States
More Information
Study ID Numbers: M02-433
Record last reviewed: March 2005
Last Updated: March 10, 2005
Record first received: March 3, 2003
ClinicalTrials.gov Identifier: NCT00055497
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: March 2005
Last Updated: March 10, 2005
Record first received: March 3, 2003
ClinicalTrials.gov Identifier: NCT00055497
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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