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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00195338 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
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Scientific title:
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A Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg |
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Date of first enrolment:
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May 2004 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00195338 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Luxembourg
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have moderate to severe active rheumatoid arthritis
- Be aged of 17 years or more
- Have inadequate response to DMards
- Give written informed consent
- Physician decides to prescribe Enbrel
Exclusion Criteria:
Age minimum:
17 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: etanercept
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Primary Outcome(s)
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Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
[Time Frame: Baseline up to Month 66]
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Secondary Outcome(s)
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Mean Dose of Concomitant Methotrexate (MTX) and Steroids
[Time Frame: Baseline up to Month 66]
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Percentage of Participants With Completion of Study Treatment
[Time Frame: Month 12 through Month 72]
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Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66
[Time Frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66]
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Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66
[Time Frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66]
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Secondary ID(s)
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0881-101343
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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