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

This study has been completed.

Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00121056
  Purpose

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   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective
Official Title:   Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations (REKinDLE)

Further study details as provided by Amgen:

Study Start Date:   September 2002

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121056

Sponsors and Collaborators
Amgen

Investigators
Study Director:     MD     Amgen    
  More Information


AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
 

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

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Interleukin 1 Receptor Antagonist Protein
Rheumatic Diseases
TNFR-Fc fusion protein

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 28, 2008




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