Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)
Completed
- Conditions
- Spondylitis, Ankylosing
- Registration Number
- NCT00725543
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 358
Inclusion Criteria
- Subjects with ankylosing spondylitis with severe axial symptoms and elevated serological markers of inflammatory activity.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy Maximum of 24 months Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy Maximum of 24 months Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy Maximum of 24 months. Median Remicade Dose Per Participant Maximum of 24 months Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy Maximum of 24 months. Mean Remicade Dose Per Participant Maximum of 24 months
- Secondary Outcome Measures
Name Time Method