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Belimumab (BENLYSTA®) Pregnancy Registry

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ClinicalTrials.gov Identifier: NCT01532310
Recruitment Status : Recruiting
First Posted : February 14, 2012
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Drug: belimumab

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Years
Official Title: WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol
Actual Study Start Date : July 16, 2012
Estimated Primary Completion Date : November 26, 2021
Estimated Study Completion Date : November 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Belimumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Pregnant women taking belimumab
Any women with belimumab exposure within the 4 months prior to and/or during pregnancy
 Drug: belimumab
Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus
Infants
Infants through the first year of life whose mothers were exposed to belimumab during pregnancy
 Drug: belimumab
Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus


Outcome Measures
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Primary Outcome Measures :
  1. Birth defects [ Time Frame: Up to one year after birth ]
    The registry will define and code birth defects with criteria specified by Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP)


Secondary Outcome Measures :
  1. Other pregnancy outcomes [ Time Frame: At birth ]
    Other pregnancy outcomes including spontaneous miscarriage, live birth (including pre-term birth and small for gestational age), stillbirth, and elective termination

  2. Infant outcomes [ Time Frame: Up to 1 year after birth ]
    Serious and/or clinically significant infections


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with SLE who have been exposed to commercially supplied belimumab within the 4 months prior to and/or during pregnancy will be eligible to participate in the registry as well as their infants.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532310


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
United States, North Carolina
GSK Investigational Site Recruiting
Wilmington, North Carolina, United States, 28401-3331
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
PPD
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Additional Information:
Belimumab pregnancy registry/GlaxoSmithKline pregnancy registries  This link exits the ClinicalTrials.gov site
A patient-centric Belimumab (Benlysta) Pregnancy Registry has been created to describe study objectives, allow visitors to download registry information and read answers to frequently asked questions (FAQs).  This link exits the ClinicalTrials.gov site

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01532310     History of Changes
Other Study ID Numbers: 114256
WEUKBRE6076 ( Other Identifier: GSK )
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
systemic lupus erythematosus
belimumab
pregnancy

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs