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

NCT ID: NCT00725543

Last Updated: 2015-09-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 358 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2010-06-30

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).

Detailed Description

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

Conditions

Spondylitis, Ankylosing

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Infliximab

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Remicade; SCH 215596

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04044

Identifier Type: -

Identifier Source: org_study_id