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Remicade in the Treatment of Patients With Active Ankylosing Spondylitis

Information source: Göteborg University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ankylosing Spondylitis

Intervention: Infliximab (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Göteborg University

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.

Clinical Details

Official title: Remicade in the Treatment of Patients With Active Ankylosing Spondylitis

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Bath AS disease activity score (BASDAI)

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Sahlgrenska University Hospital, Gothenburg S-413 45, Sweden
Additional Information

Starting date: January 2003
Last updated: May 8, 2013

Page last updated: August 23, 2015

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