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Completed

NCT Number: NCT00725543

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

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).

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Key information

Conditions

Spondylitis, Ankylosing Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infliximab

Biological

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.

Other names: Remicade, SCH 215596

Primary outcomes

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

    Time frame: Maximum of 24 months

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

    Time frame: Maximum of 24 months

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

    Time frame: Maximum of 24 months.

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

    Time frame: Maximum of 24 months.

  5. Mean Remicade Dose Per Participant

    Time frame: Maximum of 24 months

  6. Median Remicade Dose Per Participant

    Time frame: Maximum of 24 months

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Centocor, Inc.

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jul 30, 2008
Registry last updated
Sep 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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