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Clinical trial

Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease

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Last updated:1st Apr 2007

The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
 

Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind 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
Enrollment: 192
Study Start Date: April 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Arms:
- Active Comparator:
Open-label adalimumab (Week 0 to Week 4)
- Active Comparator: Low-Dose Adalimumab: 20 mg or 10 mg eow (Week 4 to Week 52)
- Active Comparator: High-Dose Adalimumab: 40 mg or 20 mg eow (Week 4 to Week 52)

Category Value
Study start date 2007-04-01

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