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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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30 January 2023 |
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Main ID: |
NCT01532310 |
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Date of registration:
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02/02/2012 |
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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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Belimumab (BENLYSTA®) Pregnancy Registry
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Scientific title:
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WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol |
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Date of first enrolment:
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July 16, 2012 |
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Target sample size:
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77 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01532310 |
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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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Spain
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Sweden
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Switzerland
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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:
- Pregnant women containing sufficient evidence to confirm that exposure to commercially
supplied belimumab occurred within the 4 months prior to and/or during pregnancy
- Pregnant women with sufficient information to classify the pregnancy as prospective or
retrospective (ie,whether the outcome of pregnancy was known at the time of first
contact with the registry)
- Pregnant women with full contact information to allow for follow-up (name, address,
telephone number/email address) and contact information for applicable HCPs if initial
reporter is the pregnant woman
- Consent provided by the pregnant woman for her participation and assent for
participation of her infant.
Exclusion Criteria:
- Reported cases that do not meet the minimum inclusion criteria for registry enrollment
will be ineligible for inclusion in the registry
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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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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Drug: belimumab
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Primary Outcome(s)
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Birth defects
[Time Frame: Up to one year after birth]
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Secondary Outcome(s)
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Infant outcomes
[Time Frame: Up to 1 year after birth]
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Other pregnancy outcomes
[Time Frame: At birth]
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Secondary ID(s)
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114256
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WEUKBRE6076
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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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