Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on Demand
Patients with active AS were randomly assigned to receive infliximab every 6 weeks (Q6), or
only upon symptoms recurrence (on-demand), following a loading regimen of infusions at weeks
0, 2, and 6. Patients in the latter group were randomly assigned to receive MTX or not,
starting 4 weeks prior to infliximab. Monitoring was performed over one year. The primary
end point was the proportion of patients with a 20% improvement response according to the
ASsessment in Ankylosing Spondylitis (ASAS) criteria, at week 54.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary end point was the proportion of patients with a 20% improvement response according to the ASAS criteria, at week 54.
Maxime DOUGADOS, Professor
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
A R C R 2003 - 01 / PO 3353