A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis.
- Conditions
- Ankylosing Spondylitis
- Registration Number
- NCT00207701
- Lead Sponsor
- Centocor, Inc.
- Brief Summary
A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with Ankylosing Spondylitis
- Detailed Description
This is a clinical research study that will determine if there is a reduction in the signs and symptoms (such as back pain and stiffness) of patients with ankylosing spondylitis with infliximab therapy. This study will also study the safety of infliximab in patients with ankylosing spondylitis. The effect of infliximab on physical function, damage to joints and the quality of life in patients with ankylosing spondylitis will also be studied. Subjects received infusions of either placebo at weeks 0, 2, 6, 12, 18 and 5 mg/kg infliximab at weeks 24, 26, 30 and every 6 weeks through week 96, or 5 mg/kg infliximab at weeks 1, 2, 6, 12, 18 and every 6 weeks through week 96
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 279
- Have had a diagnosis of definite Akylosing Spondylitis for at least 3 months prior to screening
- Have active disease with spinal pain
- receiving or intolerant to standard anti-inflammatory agents
- Have Rheumatoid Arthritis, systemic lupus erythematosus, or other inflammatory rheumatic disease
- Have a documented history of fibromyalgia
- Have total ankylosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24.
- Secondary Outcome Measures
Name Time Method The change from baseline in BASFI at week 24, the proportion of subjects who achieved an AS major clinical response at week 24, and the change from baseline in the physical component summary score of the SF-36 at week 24