NCT00844805

Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)

Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study was to assess the proportion of participants in the infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of participants with moderate-to-severe active axial spondyloarthritis and disease duration of ≤3 years, who achieve the Assessment in Ankylosing Spondylitis (ASAS) partial remission criteria.

Detailed description

In the 28-week treatment phase, participants were randomized to receive either infliximab plus naproxen or placebo plus naproxen. After 28-weeks of treatment, participants that achieved partial remission in the treatment phase were randomized to continued treatment with naproxen or to receive no treatment and were followed for an additional 24 weeks (follow-up phase).

Conditions

• Ankylosing Spondylitis
• Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Infliximab
DRUG	Placebo
DRUG	Naproxen

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-04-01
• Completion: 2011-09-01
• First posted: 2009-02-16
• Last updated: 2017-04-12
• Results posted: 2012-12-17