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

• ClinicalTrials.gov Identifier: NCT00207701
• Recruitment Status: Completed
• First Posted: September 21, 2005
• Last Update Posted: May 17, 2011
• Sponsor: Centocor, Inc.
• Collaborator: Centocor BV
• Information provided by: Centocor, Inc.

Study Description

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

Study Design

• 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

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Sponsors and Collaborators

Centocor, Inc.

Centocor BV

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 

| 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 

Publications of Results:

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. doi: 10.1002/art.22097.

Braun J, Landewe 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. doi: 10.1002/art.21790.

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. doi: 10.1002/art.20852.

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

Webers C, Stolwijk C, Schiepers O, Schoonbrood T, van Tubergen A, Landewe R, van der Heijde D, Boonen A. Infliximab treatment reduces depressive symptoms in patients with ankylosing spondylitis: an ancillary study to a randomized controlled trial (ASSERT). Arthritis Res Ther. 2020 Sep 29;22(1):225. doi: 10.1186/s13075-020-02305-w.

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. doi: 10.1002/art.24001.

• ClinicalTrials.gov Identifier: NCT00207701
• Obsolete Identifiers: NCT01128504
• Other Study ID Numbers: CR004792
• 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; Spondylarthritis; Spondylitis, Ankylosing; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Spondylarthropathies; Ankylosis; Infliximab; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Dermatologic Agents; Gastrointestinal Agents; Antirheumatic Agents