Belimumab (BENLYSTA®) Pregnancy Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by GlaxoSmithKline
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01532310
First received: February 2, 2012
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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 Intervention
Systemic Lupus Erythematosus
Drug: belimumab

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Years
Official Title: Belimumab (BENLYSTA®) Pregnancy Registry (BPR) - Prospective Cohort Study of Pregnancy Outcomes Following Benlysta Exposure Within 4 Months Prior to and/or During Pregnancy

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Birth defects [ Time Frame: Up to one year after birth ] [ Designated as safety issue: Yes ]
    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:
  • Other pregnancy outcomes [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
    Other pregnancy outcomes including spontaneous miscarriage, live birth (including pre-term birth and small for gestational age), stillbirth, and elective termination

  • Infant outcomes [ Time Frame: Up to 1 year after birth ] [ Designated as safety issue: Yes ]
    Serious and/or clinically significant infections


Estimated Enrollment: 500
Study Start Date: July 2012
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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

Additional Information:
No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01532310     History of Changes
Other Study ID Numbers: 114256, WEUKBRE6076
Study First Received: February 2, 2012
Last Updated: July 31, 2013
Health Authority: Europe: No Health Authority
United States: No Health Authority
Canada: No Health Authority

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014