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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00725543
First Posted: July 30, 2008
Last Update Posted: September 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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).

Condition Intervention
Spondylitis, Ankylosing Biological: Infliximab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remicade Therapy in Ankylosing Spondylitis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 358
Study Start Date: June 2004
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with AS will receive Remicade induction therapy at specialized centers.
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725543     History of Changes
Other Study ID Numbers: P04044
First Submitted: July 25, 2008
First Posted: July 30, 2008
Results First Submitted: June 13, 2011
Results First Posted: July 7, 2011
Last Update Posted: September 30, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents