Remicade in the Treatment of Patients With Active Ankylosing Spondylitis

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: Infliximab

• Registration Number: NCT01850121
• Lead Sponsor: Göteborg University

Brief Summary

The aim of the study was to evaluate the efficacy of infliximab (IFX) treatment, 5 mg/kg every 6 weeks, in patients with active ankylosing spondylitis (AS) and to determine whether IFX dose reduction and interval extension, 3 mg/kg every 8 weeks during the second year sustained the treatment effect. The study was started in 2003 an finished in 2008.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

The patients had to fulfill the following four inclusion criteria:

(I) Age between 18 and 60 years, (II) proven diagnosis according to the modified New York criteria 12 for definitive AS, (III) active disease with Bath AS Disease Activity Index (BASDAI) score above 4 and (IV) current or previous treatment with conventional non-steroidal anti-inflammatory drugs (NSAID) in adequate doses without sufficient effect.

Exclusion Criteria

• current signs or symptoms of severe, progressive or uncontrolled hepatic, hematological, pulmonary, cardiac, neurological or cerebral disease;
• ongoing or past serious infection (including HIV and past or current tuberculosis);
• pregnancy or breast feeding;
• current malignancy or history of malignancy within the past five years;
• congestive heart failure and any contraindication to MRI.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infliximab	Infliximab	Patients with active AS defined as BASDAI score above 4 and no exclusion criteria were consecutively included in this single-armed unblinded trial.

Primary Outcome Measures

Name	Time	Method
Bath AS disease activity score (BASDAI)	16 weeks	The proportion of responders at week 16 defined as a reduction of 50% and/or 2 units improvement from baseline of Bath AS disease activity score (BASDAI)

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden