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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: |
NCT00987831 |
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Date of registration:
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30/09/2009 |
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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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Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)
BOLD |
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Scientific title:
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Biomarkers of Lupus Disease: Study of Biomarker Changes Before and After Treatment With Depomedrol and Background Medication Withdrawal in Patients With Mild to Moderate SLE Disease Activity |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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158 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00987831 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Joan T Merrill |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oklahoma Medical Research Foundation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
SLE Groups (Group A and B):
1. ACR criteria for SLE.
2. At least two organ systems moderately active to a minimum of BILAG B or SLEDAI score
of 6.
Control group (Group C):
1. Age, ethnicity and gender matched (2:1) with an SLE study participant.
2. Free of active or major chronic disease as determined by brief history.
Exclusion Criteria:
1. Safety or circumstantial reasons why volunteer cannot comply with the protocol.
Age minimum:
14 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Other: Blood drawing only Group C
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Drug: Group A SLE prospective study
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Other: Group B SLE one blood donation
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Primary Outcome(s)
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Time to Flare Comparing Patients With Moderate vs Severe Disease Activity at Baseline
[Time Frame: 12 months]
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Secondary ID(s)
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Pfizer Inc
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OMRF 09-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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