REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00121056
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study is to determine if Enbrel® or Kineret® will have a positive effect on subject functionality as measured by the Health Assessment Questionnaire Disability Index (HAQDI).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-19
• Study First Posted: 2005-07-21
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-04
• Last Update Posted: 2008-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subjects with active rheumatoid arthritis as defined by ACR criteria - Able to start Enbrel® or Kineret® therapy (per the approved product monographs) within approximately 30 days of confirmed enrolment

Exclusion Criteria

• Active infections at the time of initiating Enbrel® or Kineret® therapy - Malignancy other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years - Known hypersensitivity to E. coli derived products - Known hypersensitivity to Enbrel® or any of its components - Subjects receiving, or who received:* Enbrel® in the previous 30 days; * Remicade® in the previous 3 months; * Humira® in the previous 3 months; * Kineret® in the previous 15 days. - Subjects beginning Enbrel® therapy, or treated with prior or current treatment using Enbrel® - Subjects beginning Kineret® therapy, or treated with prior or current treatment using Kineret® - Treatment with any investigational therapy in the 30 days prior to enrolment confirmation - Presence of any significant and uncontrolled medical condition which, in the investigator's opinion, precludes the use of Enbrel® - Sepsis or at risk of septic syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified