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Sponsored by: |
Abbott |
---|---|
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00055497 |
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).
This study was extended post week 52.
Condition | Intervention | Phase |
---|---|---|
Crohn's Disease |
Biological: adalimumab Biological: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 276 |
Study Start Date: | August 2002 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator |
Biological: placebo
Placebo every week
|
adalimumab EW: Placebo Comparator |
Biological: adalimumab
During blinded phase and during open label phase: adalimumab 40 mg Every Week Dosing
|
adalimumab EOW: Placebo Comparator |
Biological: adalimumab
During blinded phase and during open label phase: Adalimumab 40 mg Every Other Week Dosing
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Responsible Party: | Abbott ( Barry Bittle, Clinical Research Manager ) |
Study ID Numbers: | M02-433 |
Study First Received: | March 3, 2003 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00055497 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Crohn's Disease Ileitis Gastrointestinal Diseases Enteritis Inflammatory Bowel Diseases Intestinal Diseases Adalimumab |
Ileal Diseases Antibodies Digestive System Diseases Crohn Disease Antirheumatic Agents Gastroenteritis Immunoglobulins |
Anti-Inflammatory Agents Ileitis Gastrointestinal Diseases Enteritis Inflammatory Bowel Diseases Intestinal Diseases Adalimumab |
Ileal Diseases Pharmacologic Actions Digestive System Diseases Therapeutic Uses Crohn Disease Gastroenteritis Antirheumatic Agents |