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

Merck Sharp & Dohme LLC358 enrolled

Overview

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).

This study population was chosen from a non-probability sample.

Study Type

OBSERVATIONAL

Enrollment

358

Conditions

Spondylitis, Ankylosing

Interventions

InfliximabBIOLOGICAL

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy

Time frame: Maximum of 24 months

Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy

Time frame: Maximum of 24 months

Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy

Time frame: Maximum of 24 months.

Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy

Time frame: Maximum of 24 months.

Mean Remicade Dose Per Participant

Time frame: Maximum of 24 months

Median Remicade Dose Per Participant

Time frame: Maximum of 24 months

Data from ClinicalTrials.gov

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