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

This study has been completed.
Sponsor:
Collaborator:
Centocor BV, Netherlands
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00207701
First received: September 13, 2005
Last updated: May 16, 2011
Last verified: August 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207701

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

Additional Information:
Publications:
Additional 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
Study First Received: September 13, 2005
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration

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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014