Investigation of 9 Consecutive Infusions of Remicade for Psoriatic Arthritis in Austria (Study P04264)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Arthritis, Psoriatic

Treatments: Biological: Remicade (Infliximab)

Study type: Observational

Funder types: Industry

Identifiers

NCT00725296

P04264

Details and patient eligibility

About

This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA).

Full description

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

Enrollment: 178 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drugs.

Exclusion criteria

• All according to contraindications in the label especially:

  • Participants with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
  • Participants with moderate or severe heart failure (NYHA class III/IV).
  • Participants with a history of hypersensitivity to infliximab or to other murine proteins, or to any of the excipients.

Trial design

178 participants in 1 patient group

Remicade (Infliximab)

Description:

Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs will receive induction infusions of Remicade at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians. A maximum of 6 maintenance infusions will be administered with the dosage and interval due to the discretion of the physicians. Whole observation period cannot exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in the Summary of Product Characteristics (SPC) is taken into consideration.

Treatment:

Biological: Remicade (Infliximab)