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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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6 February 2023 |
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Main ID: |
NCT01729455 |
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Date of registration:
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14/11/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
SABLE |
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Scientific title:
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A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab) |
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Date of first enrolment:
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February 21, 2013 |
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Target sample size:
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3138 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01729455 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Argentina
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Austria
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Belgium
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Canada
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France
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Germany
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Israel
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Italy
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Portugal
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Slovakia
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Spain
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Sweden
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United States
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males or females age 18 years or older.
- Have a clinical diagnosis of active SLE.
- Current or history of autoantibody-positive SLE.
- Must be treated with SLE therapy including BENLYSTA and/or immunosuppressants (for
example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics).
- Have the ability to understand the requirements of the study, provide written informed
consent, including consent for the use and disclosure of research-related health
information, and comply with the study data collection procedures.
Exclusion Criteria:
- Treatment with an investigational drug within one year of enrollment. Investigational
drug applies to any drug not approved for sale in the country it is being used.
- Currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a
continuation protocol where belimumab is used as an investigational agent.
- Participants who have a history of BENLYSTA exposure, but are not currently receiving
BENLYSTA.
- Participants only receiving an anti-malarial for SLE.
- Participants only receiving steroids for SLE.
Age minimum:
18 Years
Age maximum:
N/A
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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Biological: BENLYSTA
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Other: SLE treatment
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Primary Outcome(s)
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Number of participants with AESI
[Time Frame: Up to 5 years]
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Secondary ID(s)
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116543
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HGS1006-C1124
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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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