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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207701
First Posted: September 21, 2005
Last Update Posted: May 17, 2011
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.
Collaborator:
Centocor BV
Information provided by:
Centocor, Inc.
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00207701


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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00207701     History of Changes
Obsolete Identifiers: NCT01128504
Other Study ID Numbers: CR004792
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: May 17, 2011
Last Verified: August 2010

Keywords provided by Centocor, Inc.:
Ankylosing Spondylitis
infusion

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents