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Sponsored by: |
Amgen |
Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00121056 |
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).
Condition | Intervention |
Rheumatoid Arthritis |
Drug: Enbrel® Drug: Kineret® |
MedlinePlus related topics: | Rheumatoid Arthritis |
Drug Information available for: | Anakinra Etanercept |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations (REKinDLE) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
AmgenTrials clinical trials website 
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Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20020145 |
First Received: | June 30, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00121056 |
Health Authority: | Canada: Health Canada |
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