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

Ankylosing Spondylitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207701
• Other study ID #: CR004792
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 16, 2011
• Start date: September 2002
• Est. completion date: February 2005

Study information

• Verified date: August 2010
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with Ankylosing Spondylitis

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

Other known NCT identifiers

• NCT01128504

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• infliximab

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centocor, Inc.	Centocor BV

References & Publications (3)

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- — View Citation

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: — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24.
Secondary	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

External Links

•   | 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
•   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