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NCT00116727 Clinical Trial

Rheumatoid Arthritis DMARD Intervention and UtilizationStudy

Rheumatoid Arthritis Clinical Trial

Official title:
Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00116727
Other study ID # 20021635
Secondary ID 016.0035
Status Completed
Phase N/A
First received June 30, 2005
Last updated May 5, 2011
Start date October 2002
Est. completion date October 2008

Study information
Verified date May 2011
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Observational

Clinical Trial 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®.

Recruitment information / eligibility
Status Completed
Enrollment 5103
Est. completion date October 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• ENBREL®
50 mg/wk SC

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Amgen Immunex Corporation, Wyeth is now a wholly owned subsidiary of Pfizer
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