NCT00085644

Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
BIOLOGICAL	adalimumab (D2E7)	Adalimumab 40 mg every other week, subcutaneous
BIOLOGICAL	placebo	Placebo every other week, subcutaneous

Timeline

• Start date: 2004-01-01
• Primary completion: 2004-12-01
• Completion: 2009-07-01
• First posted: 2004-06-16
• Last updated: 2011-04-21
• Results posted: 2010-03-11

Locations

22 sites across 1 country: United States