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

NCT ID: NCT00725296

Last Updated: 2015-11-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 178 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2010-07-31

Brief Summary

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).

Detailed Description

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

Conditions

Arthritis, Psoriatic

Study Design

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

Study Groups

Remicade (Infliximab)

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.

Remicade (Infliximab)

Intervention Type: BIOLOGICAL

Induction infusions of Remicade will be administered 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.

Interventions

Remicade (Infliximab)

Induction infusions of Remicade will be administered 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Remicade; SCH 215596

Eligibility Criteria

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.

• 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

P04264

Identifier Type: -

Identifier Source: org_study_id