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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 February 2015 |
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Main ID: |
NCT01400464 |
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Date of registration:
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21/07/2011 |
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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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Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
PREDICORT |
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Scientific title:
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Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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150 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01400464 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of GCA, meeting at least 3 of the following 5 American College of
Rheumatology (ACR) criteria for the diagnosis of GCA:
1. At least 50 years of age at disease onset
2. New onset or new type of localized pain in the head
3. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or
decreased pulsation unrelated to arteriosclerosis of cervical arteries)
4. ESR of greater than 40 mm in the first hour by the Westergren method
5. Temporal artery biopsy showing vasculitis characterized by a predominance of
mononuclear cell infiltration or granulomatous inflammation, usually with
multinucleated giant cells
- Corticoid treatment since less than 14 days
- Signed informed consent
- Affiliation to the social security system
Exclusion Criteria:
- Dementia
- Predictable non observance
- Neoplasia since less than 5 years
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Giant Cell Arteritis
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Intervention(s)
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Drug: Prednisone therapy and pharmacokinetic
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Primary Outcome(s)
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oral clearance of prednisolone
[Time Frame: 2 to 4 weeks after begining prednisolone treatment]
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Secondary ID(s)
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2008-004896-23
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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