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Sponsored by: |
Abbott |
---|---|
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00686374 |
Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806
Condition | Intervention | Phase |
---|---|---|
Crohn's Disease |
Biological: Adalimumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Open-Label Study of the Human Anti−TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study |
Estimated Enrollment: | 130 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Heavier population, greater than or equal to 40kg, will receive 40mg
|
Biological: Adalimumab
Pre-filled syringe, 40mg/20mg EOW or 40mg/20mg EW for up to 104 weeks.
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2: Active Comparator
Lighter population, less than 40kg, will receive 20mg
|
Biological: Adalimumab
Pre-filled syringe, 40mg/20mg EOW or 40mg/20mg EW for up to 104 weeks.
|
Ages Eligible for Study: | 7 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If female, subjects who are sexually active and are of child-bearing potential should be practicing an approved method of birth control throughout the study and for 150 days after study drug administration. Examples of approved methods of birth control include the following:
Exclusion Criteria:
Contact: Barry Bittle | 1-973-394-5477 | barry.bittle@abbott.com |
Responsible Party: | Abbott ( Barry Bittle, CRM ) |
Study ID Numbers: | M06-807 |
Study First Received: | May 27, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00686374 |
Health Authority: | United States: Food and Drug Administration |
Crohn's Disease |
Antibodies, Monoclonal Antibodies Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Adalimumab Gastroenteritis Intestinal Diseases Immunoglobulins |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Pharmacologic Actions |