Remicade Safety Line (Study P03236)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Arthritis, Rheumatoid

Treatments: Biological: Infliximab

Study type: Observational

Funder types: Industry

Identifiers

NCT00748826

P03236

Details and patient eligibility

About

The goal of this study is to implement instruments that would increase the treating physician's awareness of the necessary tuberculosis screening when starting a new patient on infliximab (Remicade) therapy who has not reacted sufficiently to disease-modifying preparations, including methotrexate.

Full description

This study used a non-probability sampling method.

Enrollment: 576 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with active rheumatoid arthritis confirmed with adequate clinical response(ACR) criteria who did not react sufficiently to disease-modifying preparations, including methotrexate, and who are receiving new treatment with infliximab.

Exclusion criteria

• As per Summary of Product Characteristics (SmPC)

Trial design

576 participants in 1 patient group

Infliximab -Rheumatoid Arthritis Participants

Treatment:

Biological: Infliximab