Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Biological: Infliximab

Study type: Observational

Funder types: Industry

Identifiers

NCT00725621

P03756

Details and patient eligibility

About

This is a prospective, open-label, 1-arm, multicenter observational study to determine the average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)

Full description

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

Enrollment: 516 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe RA (indication according to Austrian labeling).

Exclusion criteria

• According to Summary of Product Characteristics (SPC).

Trial design

516 participants in 1 patient group

Remicade

Description:

Patients with severe RA (indication according to Austrian labeling) will receive Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions. Remicade induction and maintenance therapy doses and intervals will be at the discretion of the physicians.

Treatment:

Biological: Infliximab