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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spondylitis, Ankylosing

Intervention: Infliximab (Biological)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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).

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

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

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

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

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

Mean Remicade Dose Per Participant

Median Remicade Dose Per Participant

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

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: June 2004
Last updated: October 23, 2014

Page last updated: August 23, 2015

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