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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00725543 |
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Date of registration:
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25/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)
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Scientific title:
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Remicade Therapy in Ankylosing Spondylitis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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358 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00725543 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spondylitis, Ankylosing
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Intervention(s)
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Biological: Infliximab
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Primary Outcome(s)
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Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
[Time Frame: Maximum of 24 months.]
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Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
[Time Frame: Maximum of 24 months.]
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Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
[Time Frame: Maximum of 24 months]
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Mean Remicade Dose Per Participant
[Time Frame: Maximum of 24 months]
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Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
[Time Frame: Maximum of 24 months]
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Median Remicade Dose Per Participant
[Time Frame: Maximum of 24 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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