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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00121056
Date of registration:	30/06/2005
Prospective Registration:	No
Primary sponsor:	Amgen
Public title:	REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations
Scientific title:	Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations (REKinDLE)
Date of first enrolment:	September 2002
Target sample size:
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00121056
Study type:	Observational
Study design:	Time Perspective: Prospective
Phase:	N/A

Countries of recruitment

Contacts

Name:	MD
Address:
Telephone:
Email:
Affiliation:	Amgen

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Enbrel®

Drug: Kineret®

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

20020145

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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