A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis. - Full Text View

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:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Infliximab

U.S. FDA Resources

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

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:

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 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

/ A Randomized, Double-blind Trial of the Efficacy of REMICADE® (Infliximab) Compared with Placebo in Subjects with Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therap This link exits the ClinicalTrials.gov site

Publications:

van der Heijde D, Han C, DeVlam K, Burmester G, van den Bosch F, Williamson P, Bala M, Han J, Braun J. Infliximab improves productivity and reduces workday loss in patients with ankylosing spondylitis: results from a randomized, placebo-controlled trial. Arthritis Rheum. 2006 Aug 15;55(4):569-74.

Braun J, Landewé R, Hermann KG, Han J, Yan S, Williamson P, van der Heijde D; ASSERT Study Group. Major reduction in spinal inflammation in patients with ankylosing spondylitis after treatment with infliximab: results of a multicenter, randomized, double-blind, placebo-controlled magnetic resonance imaging study. Arthritis Rheum. 2006 May;54(5):1646-52.

van der Heijde D, Dijkmans B, Geusens P, Sieper J, DeWoody K, Williamson P, Braun J; Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy Study Group. Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum. 2005 Feb;52(2):582-91.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Braun J, Deodhar A, Dijkmans B, Geusens P, Sieper J, Williamson P, Xu W, Visvanathan S, Baker D, Goldstein N, van der Heijde D; Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy Study Group. Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period. Arthritis Rheum. 2008 Sep 15;59(9):1270-8.

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
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013