Status:
WITHDRAWN
Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Hospital Universitario Reina Sofia de Cordoba
Dr. Jose María Martos Becerra (Central Radiological Assessment) - Hospital de Alta Resolución, Puente Genil (Spain)
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01148901
Start Date
June 1 2010
End Date
December 1 2010
Last Update
April 30 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.