Overview

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

Status:
Withdrawn

Trial end date:
2010-12-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 4

Details

Lead Sponsor:

Merck Sharp & Dohme Corp.

Collaborators:

Dr. Jose María Martos Becerra (Central Radiological Assessment) - Hospital de Alta Resolución, Puente Genil (Spain)
Hospital Universitario Reina Sofia
Hospital Universitario Reina Sofia de Cordoba

Treatments:

Infliximab