Status:
COMPLETED
Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Centocor, Inc.
Conditions:
Spondylitis, Ankylosing
Eligibility:
All Genders
Brief Summary
This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time span of Remicade between infusions for ankylosing spondylitis (AS).
Detailed Description
This study population was chosen from a non-probability sample.
Eligibility Criteria
Inclusion
- Subjects with ankylosing spondylitis with severe axial symptoms and elevated serological markers of inflammatory activity.
Exclusion
- Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
- Subjects with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).
- Subjects with a history of hypersensitivity to Remicade or to other murine proteins, or to any of the excipients.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT00725543
Start Date
June 1 2004
End Date
June 1 2010
Last Update
September 30 2015
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