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

Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Enbrel (Drug); Kineret (Drug)

Phase: N/A

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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).

Clinical Details

Official title: Registry With Enbrel or Kineret in a Database Using Longitudinal Evaluations (REKinDLE)

Study design: Prospective

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: September 2002
Last updated: December 20, 2007

Page last updated: June 20, 2008

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