drugset / Trial / NCT00439283

Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis

NCT00439283 ↗

Phase 3 Completed 240 enrolled Association de Recherche Clinique en Rhumatologie
RandomizedParallel-groupOpen-labelTreatment

Summary

Continuous treatment with the anti-tumor necrosis factor alpha monoclonal antibody infliximab is efficacious in ankylosing spondylitis (AS), whereas treatment discontinuation results in disease relapse, with variable delay. Objective of this study was to compare efficacy between a continuous treatment with infliximab, and a treatment adapted to symptoms recurrence. Addition of methotrexate (MTX)to infliximab was also tested.

Timeline

Start
2003-04
Primary completion
—
Completion
2004-12

Outcome

Met primary endpoint

paper patients receiving infliximab every 6 weeks fulfilled ASAS20 response criteria at week 58 than did patients receiving on-demand treatment (75% versus 46%; P<0.0001). PMID 18163509 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody — —
Subject Methotrexate Small molecule — —