Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352)

Summary

This is a randomized, double-blind, multi-center, placebo-controlled study with two parallel treatment groups (placebo and infliximab) in subjects with ankylosing spondylitis (AS) to evaluate the efficacy of infliximab 3 mg/kg.

Timeline

Start

2005-05-01

Primary completion

2007-05-01

Completion

2007-05-01

Outcome

Met primary endpoint

paper At 12 weeks, 53.8% of IFX-treated patients achieved ASAS20, compared with 30.6% of placebo-treated patients (p = 0.042). PMID 20231198 ↗

Publications

• Results Inman RD, Maksymowych WP; CANDLE Study Group. A double-blind, placebo-controlled trial of low dose infliximab in ankylosing spondylitis. J Rheumatol. 2010 Jun;37(6):1203-10. doi: 10.3899/jrheum.091042. Epub 2010 Mar 15.

Drugs

Indications