Status:
COMPLETED
Remicade in the Treatment of Patients With Active Ankylosing Spondylitis
Lead Sponsor:
Göteborg University
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-60 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01850121
Start Date
January 1 2003
End Date
May 1 2008
Last Update
August 9 2016
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45