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NCT Number: NCT00207701

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

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

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infliximab

Drug

Primary outcomes

  1. The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centocor, Inc.

Industry

Collaborators

  • Centocor BV

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
May 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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