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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00121056
First received: June 30, 2005
Last updated: December 4, 2008
Last verified: December 2008

June 30, 2005
December 4, 2008
September 2002
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Complete list of historical versions of study NCT00121056 on ClinicalTrials.gov Archive Site
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REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations
Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations (REKinDLE)

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).

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Observational
Time Perspective: Prospective
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Rheumatoid Arthritis
  • Drug: Enbrel®
  • Drug: Kineret®
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00121056
20020145
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Global Development Leader, Amgen Inc.
Amgen
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Study Director: MD Amgen
Amgen
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP