Remicade in the Treatment of Patients With Active Ankylosing Spondylitis
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Remicade in the Treatment of Patients With Active Ankylosing Spondylitis|
- Bath AS disease activity score (BASDAI) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]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)
Biospecimen Retention: Samples Without DNA
|Study Start Date:||January 2003|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Patients with active AS defined as BASDAI score above 4 and no exclusion criteria were consecutively included in this single-armed unblinded trial.
5 mg/kg every 6 weeks during the first year and 3 mg/kg every 8 weeks during the second year. Concomitant treatment with methotrexate 7.5 mg/week.
Other Name: Remicade