Rheumatoid Arthritis DMARD Intervention and UtilizationStudy

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: ENBREL®

• Registration Number: NCT00116727
• Lead Sponsor: Amgen

Brief Summary

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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-01
• Primary Completion: 2008-06
• Study Completion: 2008-10
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-05
• Last Update Posted: 2011-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5103

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug	ENBREL®	etanercept 50 mg/wk SC