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

NCT00725543 | Completed Results

• 1 other identifier: P04044
• Study Type: observational
• Target: 358
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Spondylitis, Ankylosing

Outcome Measures

Primary Outcomes (6)

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

  Maximum of 24 months

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

  Maximum of 24 months

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

  Maximum of 24 months.

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

  Maximum of 24 months.

• Mean Remicade Dose Per Participant

  Maximum of 24 months

• Median Remicade Dose Per Participant

  Maximum of 24 months

Study Arms (1)

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

Interventions

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.

Also known as: Remicade, SCH 215596

Remicade

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Subjects with ankylosing spondylitis with severe axial symptoms and elevated serological markers of inflammatory activity.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Centocor, Inc.: collaborator

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Infliximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 30, 2008
• Study Start: June 1, 2004
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 30, 2015
• Results First Posted: July 7, 2011

Record last verified: 2015-09