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• Status: Withdrawn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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• 18 years of age or older

• Ankylosing spondylitis (AS) diagnosis

• Have all 3 of the following:

• Presence of hip pain (nocturnal inflammatory pain)

• Limitation of hip mobility

• Patient's Global Assessment Visual Analog Scale (0-10 cm) ≥4 cm.

• Inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs)

• Eligible to be treated with Infliximab (Remicade®)

Exclusion Criteria:

• Causes of coaxalgia other than coxitis of AS, demonstrated by images or laboratory tests

• Women who are pregnant or nursing or plan to nurse or become pregnant

• Serious infections like sepsis, abscesses.

• History of or current certain infections

• History of or current certain medical conditions