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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: |
NCT00001954 |
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Date of registration:
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18/01/2000 |
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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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Etanercept Therapy for Sjogren's Syndrome
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Scientific title:
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Etanercept Therapy for Sjogren's Syndrome |
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Date of first enrolment:
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December 1999 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00001954 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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INCLUSION CRITERIA
Documented primary or secondary SS.
Absence of confounding health problems.
No contraindications to etanercept therapy.
SS patients cannot have sarcoidosis, HIV infection, or lymphoma.
Patients must have one of the following abnormal autoimmune serologies associated with SS
(i.e. positive ANA, RF, and anti-SS-A, or anti-SS-B).
Patients may use pilocarpine provided that they hold their dose on visit days when saliva
is collected.
Patients taking DMARD's, such as hydroxychloroquine, must be on a stable dose.
Participants may take NSAIDs or acetaminophen.
EXCLUSION CRITERIA
Patients must not have physical or mental conditions that may make them unable to comply.
Subjects may continue their other long-term medications with the exception of tricyclic
antidepressants and anti-cholinergics, which may affect salivary gland function.
Patients cannot take experimental drugs during the duration of the protocol.
Children will be excluded due to additional risks that may occur with etanercept.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sjogren's Syndrome
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Intervention(s)
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Drug: Etanercept
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Secondary ID(s)
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000026
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00-D-0026
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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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