Rheumatoid Arthritis DMARD Intervention and UtilizationStudy

Amgen

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: ENBREL®

Study type: Observational

Funder types: Industry

Identifiers

NCT00116727

20021635

016.0035

Details and patient eligibility

About

To systematically collect and document use patterns, effectiveness and safety of DMARD treatments currently used in the management of rheumatoid arthritis. The primary purpose of this study is to estimate the incidence of serious adverse experiences and adverse experiences of interest in patients with rheumatoid arthritis (RA) treated with ENBREL®.

Enrollment: 5,103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fulfillment of the 1987 American Rheumatism Association criteria for RA
• Currently requiring the addition of ENBREL® therapy (to be taken alone or in addition to their current DMARD therapy)

Exclusion criteria

• Currently or previously enrolled in RADIUS 1
• Currently enrolled in a clinical trial where treatments or patient visits are imposed by a protocol
• Active infections
• Known allergy to ENBREL® or any of its components
• Current treatment with ENBREL®
• Patients who have previously been demonstrated to be intolerant of or refractory to ENBREL® therapy
• Nursing or pregnant women

Trial design

5,103 participants in 1 patient group

Drug

Description:

etanercept 50 mg/wk SC

Treatment:

Drug: ENBREL®