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

September 28, 2015 updated by: Merck Sharp & Dohme LLC

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

358

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with AS will receive Remicade induction therapy at specialized centers.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Remicade
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Time Frame: Maximum of 24 months
Maximum of 24 months
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Time Frame: Maximum of 24 months
Maximum of 24 months
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Time Frame: Maximum of 24 months.
Maximum of 24 months.
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Time Frame: Maximum of 24 months.
Maximum of 24 months.
Mean Remicade Dose Per Participant
Time Frame: Maximum of 24 months
Maximum of 24 months
Median Remicade Dose Per Participant
Time Frame: Maximum of 24 months
Maximum of 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Centocor, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (Estimate)

July 30, 2008

Study Record Updates

Last Update Posted (Estimate)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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