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

Completed

• Conditions: Spondylitis, Ankylosing
• Interventions: Biological: Infliximab

• 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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-30
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2011-06-13
• Results First Submitted QC: 2011-06-13
• Results First Posted: 2011-07-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-30

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Remicade	Infliximab	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.

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