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Trial record 1 of 1 for:    NCT00207701
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A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis.

This study has been completed.
Centocor BV
Information provided by:
Centocor, Inc. Identifier:
First received: September 13, 2005
Last updated: May 16, 2011
Last verified: August 2010
A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with Ankylosing Spondylitis

Condition Intervention Phase
Ankylosing Spondylitis Drug: infliximab Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Centocor, Inc.:

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

Secondary Outcome Measures:
  • 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

Enrollment: 279
Study Start Date: September 2002
Study Completion Date: February 2005
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00207701

Sponsors and Collaborators
Centocor, Inc.
Centocor BV
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00207701     History of Changes
Obsolete Identifiers: NCT01128504
Other Study ID Numbers: CR004792
Study First Received: September 13, 2005
Last Updated: May 16, 2011

Keywords provided by Centocor, Inc.:
Ankylosing Spondylitis

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents processed this record on August 18, 2017