Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451)

Summary

This trial is designed to measure improvement of hip involvement in patients with ankylosing spondylitis (AS) after receiving 4 doses of infliximab. Participants will receive infliximab 5 mg/kg (as an intravenous perfusion over a period of 2 hours) at Weeks 0, 2, 6, and 14, consistent with the approved dosing regimen described in the label. Participants will be evaluated for hip pain, functional capacity and stiffness before and after 14 weeks (4 doses) of treatment. Further treatment after 4 doses is based on standard clinical practice as determined by the trial site.

Timeline

Start

2010-06

Primary completion

2010-12

Completion

2010-12

Outcome

Outcome not reported

Stopped (Enrollment): “No patient enrolled after 6 months from the start. The decision to withdraw the study was based on a feasibility reevaluation conducted with investigators.”

Drugs

Indications