Last updated: 02/01/2023 09:52:28
The Belimumab (BENLYSTA) and lupus Pregnancy Exposure StudybMUM
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: The Belimumab Pregnancy Exposure Study: An OTIS Autoimmune Diseases in Pregnancy Project
Trial description: The purpose of this study is to monitor planned and unplanned pregnancies exposed to belimumab and to determine whether there is a signal for belimumab teratogenicity when compared to the background rate in an unexposed Systemic lupus erythematosus (SLE) cohort. BENLYSTA is the trademark of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of live birth pregnancies with major birth defect among pregnancies with at least one live births
Timeframe: At birth or up to 1 year of age
Secondary outcomes:
Number of pregnant women who had spontaneous abortion
Timeframe: Up to 20 weeks gestation
Number of pregnant women who had stillbirth
Timeframe: At birth
Number of pregnant women who had elective termination of pregnancy
Timeframe: During Pregnancy (Up to 36 weeks)
Number of pregnant women who had preterm delivery
Timeframe: At birth
Number of infants categorized as Small for Gestational Age (SGA) at birth
Timeframe: At birth
Number of infants with minor birth defect pattern
Timeframe: From birth up to 1 year of age
Number of infants with post-natal growth deficiency
Timeframe: From birth up to 1 year of age
Number of infants with developmental concerns
Timeframe: At 1 year of age
Number of infants with serious infections
Timeframe: From birth up to 1 year of age
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2029-30-08
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Organization of Teratology Information Specialists
Study date(s)
December 2022 to August 2029
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
Not applicable
Accepts healthy volunteers
No
- For Cohort 1: Belimumab-Exposed group:
- Eligible pregnant women diagnosed with SLE who contact the MotherTo Baby/Organization of Teratology Information Specialists (OTIS) Research Center and who have been exposed to belimumab for any number of days, at any dose, and at any time from 3 months prior to the first day of the Last menstrual period (LMP) up to and including the end of pregnancy.
- For Cohort 1: Belimumab-Exposed group:
- Women will not be eligible for Cohort 1 if they first contacted the OTIS Research Center after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment, retrospective enrollment).
Inclusion and exclusion criteria
Inclusion criteria:
- For Cohort 1: Belimumab-Exposed group:
- Eligible pregnant women diagnosed with SLE who contact the MotherTo Baby/Organization of Teratology Information Specialists (OTIS) Research Center and who have been exposed to belimumab for any number of days, at any dose, and at any time from 3 months prior to the first day of the Last menstrual period (LMP) up to and including the end of pregnancy.
- Eligible pregnant women who agree to the conditions and requirements of the study including informed consent, the interview schedule and release of medical records. For Cohort 2: Belimumab-Unexposed Disease Comparator Group:
- Eligible pregnant women diagnosed with SLE but who were not exposed to belimumab from 3 months prior to LMP or anytime during pregnancy (but may have been exposed to other medications for treatment of SLE during the same time period).
- Eligible pregnant women who agree to the conditions and requirements of the study including informed consent, the interview schedule and release of medical records.
Exclusion criteria:
- For Cohort 1: Belimumab-Exposed group:
- Women will not be eligible for Cohort 1 if they first contacted the OTIS Research Center after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment, retrospective enrollment).
- Women will not be eligible for Cohort 1 if results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
- Women will not be eligible for Cohort 1 if they have enrolled in the belimumab study with a previous pregnancy. For Cohort 2: Belimumab-Unexposed Disease Comparator Group:
- Women who have received treatment with belimumab from 3 months prior to the first day of the LMP up to and including the end of pregnancy but who are not eligible for Cohort 1 will not be eligible for Cohort 2.
- Women will not be eligible for Cohort 2 if they first contact the OTIS Research Center after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment, retrospective enrollment).
- Women will not be eligible for Cohort 2 if results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.
- Women will not be eligible for Cohort 2 who have enrolled in the belimumab study during previous pregnancy.
Trial location(s)
Location
GSK Investigational Site
La Jolla, California, United States, 92093
Status
Recruiting
Study documents
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Additional information
Not applicable
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