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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00725543
First received: July 25, 2008
Last updated: June 13, 2011
Last verified: June 2011
History of Changes
  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:

Drug Information available for: Infliximab
U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy [ Time Frame: Maximum of 24 months ] [ Designated as safety issue: No ]
  • Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy [ Time Frame: Maximum of 24 months ] [ Designated as safety issue: No ]
  • Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy [ Time Frame: Maximum of 24 months. ] [ Designated as safety issue: No ]
  • Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy [ Time Frame: Maximum of 24 months. ] [ Designated as safety issue: No ]
  • Mean Remicade Dose Per Participant [ Time Frame: Maximum of 24 months ] [ Designated as safety issue: No ]
  • Median Remicade Dose Per Participant [ Time Frame: Maximum of 24 months ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00725543     History of Changes
Other Study ID Numbers: P04044
Study First Received: July 25, 2008
Results First Received: June 13, 2011
Last Updated: June 13, 2011
Health Authority: Austria: Not Required

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
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013