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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00207701
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 17, 2011
Centocor BV
Information provided by:
Centocor, Inc.

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

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: infliximab Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : September 2002
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

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

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00207701

Sponsors and Collaborators
Centocor, Inc.
Centocor BV
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Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00207701    
Obsolete Identifiers: NCT01128504
Other Study ID Numbers: CR004792
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: August 2010
Keywords provided by Centocor, Inc.:
Ankylosing Spondylitis
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents