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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Spondylitis, Ankylosing

Treatments: Biological: Infliximab

Study type: Observational

Funder types: Industry

Identifiers

NCT00725543

P04044

Details and patient eligibility

About

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).

Full description

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

Enrollment: 358 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

358 participants in 1 patient group

Remicade

Description:

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.

Treatment:

Biological: Infliximab