Ankylosing Spondylitis Clinical Trial
Official title:
Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial
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.
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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