NCT00202865

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

CANaDian Evaluation of Low DosE Infliximab in Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spondylitis, Ankylosing

Interventions

Type	Name	Description
BIOLOGICAL	infliximab	Infliximab 3 mg/kg infusions at Weeks 0, 2, and 6 and every 8 weeks thereafter. Subjects who lose response according to a pre-specified criteria at weeks 22 or 38 visit will increase the dose of infliximab to 5 mg/kg (rounded up to the nearest vial).
BIOLOGICAL	Placebo	Placebo infusions at Weeks 0, 2, and 6. Subjects will be evaluated at Week 12 after which they will receive infliximab 3 mg/kg at Weeks 16, 18, and 22 then every 8 weeks. Subjects who lose response according to a pre-specified criteria at weeks 22 or 38 visit will increase the dose of infliximab to 5 mg/kg (rounded up to the nearest vial).

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2005-09-20
• Last updated: 2017-03-24