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

Centocor Ortho Biotech

Status and phase

Completed

Phase 3

Conditions

Ankylosing Spondylitis

Treatments

Drug: infliximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00207701

CR004792

Details and patient eligibility

About

A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with Ankylosing Spondylitis

Full 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

Enrollment

279 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Have Rheumatoid Arthritis, systemic lupus erythematosus, or other inflammatory rheumatic disease
Have a documented history of fibromyalgia
Have total ankylosis