N/A
Completed N=358
Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)
Spondylitis, Ankylosing
Source: ClinicalTrials.gov NCT00725543 ↗
Enrolled (actual)
358
Serious AEs
1.1%
Results posted
Jul 2011
Primary outcomePrimary: Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy — 56.10; 60.62; 57.91; 59.39 Days
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy |
56.10; 60.62; 57.91; 59.39; 59.52; 60.36 | — |
| PRIMARY Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy |
57.00; 57.00; 57.00; 57.00; 57.00; 57.00 | — |
| PRIMARY Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy |
4.37; 4.39; 4.43; 4.42; 4.44; 4.47 | — |
| PRIMARY Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy |
4.60; 4.62; 4.62; 4.62; 4.62; 4.66 | — |
| PRIMARY Mean Remicade Dose Per Participant |
4.53 | — |
| PRIMARY Median Remicade Dose Per Participant |
4.75 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00725543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.