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

Phase 4

Withdrawn

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: Infliximab

• Registration Number: NCT01148901
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remicade	Infliximab	Infliximab 5 mg/kg was administered as specified in the Summary of Product Characteristics for patients with ankylosing spondylitis

Primary Outcome Measures

Name	Time	Method
Number of participants with clinical improvement assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire	Baseline and Week 15