NCT00207701

A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis.

A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	infliximab

Timeline

• Start date: 2002-09-01
• Completion: 2005-02-01
• First posted: 2005-09-21
• Last updated: 2011-05-17