Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)

Study Overview
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Brief Summary
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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
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This study population was chosen from a non-probability sample.

Official Title
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Remicade Therapy in Ankylosing Spondylitis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions

Conditions
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Spondylitis, Ankylosing

Intervention / Treatment
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* Biological: Infliximab


Participation Criteria
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Eligibility 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Remicade<br>Subjects with AS with severe axial symptoms and elevated serological markers of inflammatory activity will receive Remicade induction therapy consisting of 3 Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions given in doses and intervals due to discretion of physicians. Whole observation period cannot exceed 102 weeks per subject if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) is taken into consideration. | Biological: Infliximab<br>* Remicade induction therapy consists of 3 infusions given at weeks 0, 2, and 6 in specialized centers. Maintenance therapy will consist of a maximum of 6 infusions given in doses and intervals due to discretion of physicians.<br>* Other names: SCH 215596;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy |  | Maximum of 24 months | 
| Median 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 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 | 
| Median Remicade Dose Per Participant |  | Maximum of 24 months |