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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00409682 |
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
Condition | Intervention | Phase |
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Crohn's Disease |
Biological: adalimumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blinded, Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease |
Estimated Enrollment: | 184 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Heavier comparator: Active Comparator
Subjects whose weight is >= 40 kg
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Biological: adalimumab
Adalimumab 160 mg and 80 mg at Weeks 0 and 2 if subject is greater than or equal to 40 kg; if a subject is < 40 kg they will receive 80 mg and 40 mg at Weeks 0 and 2.
Biological: adalimumab
One of two maintenance groups ( low-dose or high-dose); Week 4 subjects stratified by weight: adalimumab 40 mg EOW (weight greater than or equal to 40 kg); or 20 mg adalimumab EOW (if weight is < 40 kg); low-dose group will receive: 20 mg adalimumab EOW if weight is greater than or equal to 40 kg or 10 mg adalimumab EOW if weight is > 40 kg.
Biological: adalimumab
Weekly dosing of adalimumab: 20 mg for subjects less than 40 kg and 40 mg for subjects who are greater than or equal to 40 kg.
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Lighter comparator: Active Comparator
Subjects whose weight is < 40 mg
|
Biological: adalimumab
Adalimumab 160 mg and 80 mg at Weeks 0 and 2 if subject is greater than or equal to 40 kg; if a subject is < 40 kg they will receive 80 mg and 40 mg at Weeks 0 and 2.
Biological: adalimumab
One of two maintenance groups ( low-dose or high-dose); Week 4 subjects stratified by weight: adalimumab 40 mg EOW (weight greater than or equal to 40 kg); or 20 mg adalimumab EOW (if weight is < 40 kg); low-dose group will receive: 20 mg adalimumab EOW if weight is greater than or equal to 40 kg or 10 mg adalimumab EOW if weight is > 40 kg.
Biological: adalimumab
Weekly dosing of adalimumab: 20 mg for subjects less than 40 kg and 40 mg for subjects who are greater than or equal to 40 kg.
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Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with a poorly controlled medical condition such as:
Contact: Barry Bittle | 973-394-5477 | barry.bittle@abbott.com |
Study Director: | Beverly A Paperiello | Abbott |
Responsible Party: | Abbott ( Barry Bittle ) |
Study ID Numbers: | M06-806 |
Study First Received: | December 8, 2006 |
Last Updated: | April 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00409682 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, Monoclonal 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 |