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Biogen Multiple Sclerosis Pregnancy Exposure Registry

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ClinicalTrials.gov Identifier: NCT01911767
Recruitment Status : Recruiting
First Posted : July 30, 2013
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date July 25, 2013
First Posted Date July 30, 2013
Last Update Posted Date April 29, 2021
Actual Study Start Date October 30, 2013
Estimated Primary Completion Date May 31, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 7, 2018)
  • Pregnancy Loss [ Time Frame: During pregnancy up to 52 weeks post-delivery ]
    • Elective or therapeutic pregnancy terminations (any induced or voluntary fetal loss during pregnancy)
    • Spontaneous abortions (<22 weeks of gestation)
    • Fetal death, including stillbirths (fetuses born dead at >=22 weeks of gestation), which will be further classified as follows:
    • early fetal loss (fetal death occurring at >=22 weeks but <28 weeks of gestation)
    • late fetal loss (occurring at >=28 weeks of gestation)
  • Live Birth [ Time Frame: During pregnancy up to 52 Weeks Post-Delivery ]
    • Premature birth (delivered <37 weeks)
    • Full-term birth (delivered >=37 weeks)
Original Primary Outcome Measures
 (submitted: July 26, 2013)
Negative birth outcomes, including spontaneous abortions and birth defects. [ Time Frame: During pregnancy up to 12 weeks post-delivery ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biogen Multiple Sclerosis Pregnancy Exposure Registry
Official Title Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry
Brief Summary The primary objective of the study is to prospectively evaluate pregnancy outcomes in women with multiple sclerosis who were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility window for that product. The Registry-specified Biogen MS products being studied are dimethyl fumarate, and Pegylated human interferon beta-1a. The secondary objective of the study is to prospectively evaluate pregnancy outcomes in women with MS who were unexposed to disease-modifying therapies (DMTs).
Detailed Description The Biogen Multiple Sclerosis Pregnancy Exposure Registry is a prospective, observational registry designed to evaluate pregnancy outcomes in women with multiple sclerosis (MS) who were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility window for that product. Women of childbearing potential are a considerable segment of the patient population affected by MS and are likely to be exposed to a Registry-specified Biogen MS product around the time of conception and during pregnancy. Biogen completed pregnancy registries for Avonex and Tysabri; however, formal studies in pregnant women have not been conducted. Therefore, it is important to evaluate, in a global Pregnancy Registry, how exposure to a marketed Biogen MS product specified in this Pregnancy Registry may affect pregnancy and infant outcomes. Data will be collected on prospective pregnancies (i.e. enrollment prior to knowledge of outcome) at time of enrollment, 6 to 7 months gestation, and approximately 4,12, and 52 weeks after estimated date of delivery. The prevalence of spontaneous abortions, birth defects, and other pregnancy and infant outcomes will be calculated and compared to background rates from external sources such as the European Surveillance of Congenital Anomalies.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 52 Weeks
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Within each product cohort, approximately 310 to 375 pregnant women exposed to a Registry-specified Biogen MS product will be enrolled in order to observe 300 prospective pregnancy outcomes. The infants born to these women will also be part of the population studied. Patients with prenatal testing prior to enrollment (with the exception of a first trimester ultrasound to date the pregnancy) will not be counted towards the 300 prospective pregnancy outcomes.
Condition
  • Multiple Sclerosis
  • Exposure During Pregnancy
Intervention
  • Drug: Dimethyl fumarate
    Administered as specified in treatment arm.
    Other Names:
    • Tecfidera
    • BG00012
    • DMF
  • Drug: Peginterferon beta-1a
    Administered as specified in treatment arm.
    Other Names:
    • Plegridy
    • BIIB017
Study Groups/Cohorts
  • Dimethyl fumarate
    Exposure to dimethyl fumarate since the first day of her last menstrual period (LMP) prior to conception or at any time during pregnancy
    Intervention: Drug: Dimethyl fumarate
  • Peginterferon beta-1a
    Exposure to Peginterferon beta-1a since 17 days prior to the first day of her LMP prior to conception or at any time during pregnancy.
    Intervention: Drug: Peginterferon beta-1a
  • Disease Modifying Therapy (DMT) Unexposed
    Never received DMT therapy; discontinued treatment with any DMT at least more than 5× half-life prior to Day 1 of her LMP and throughout the entire pregnancy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 7, 2018)
1125
Original Estimated Enrollment
 (submitted: July 26, 2013)
375
Estimated Study Completion Date December 31, 2028
Estimated Primary Completion Date May 31, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria

Key Inclusion Criteria:

  • Patient consent
  • Patient has a diagnosis of MS.
  • Documentation that the patient was exposed to a Registry-specified Biogen MS product during the eligibility window for that product.
  • DMF: Exposure since the first day of her last menstrual period (LMP) prior to conception or at any time during pregnancy.
  • Peginterferon beta-1a: Exposure since 17 days prior to the first day of her LMP prior to conception or at any time during pregnancy.
  • DMT unexposed pregnancy cohort: Never received DMT therapy
  • Patient agrees to sign the Release of Medical Information Form, thereby permitting the Registry to contact her health care provider (HCP(s)) and the pediatric HCP for medical information.

Key Exclusion Criteria:

  • The outcome of the pregnancy (i.e., pregnancy loss or live birth) must not be known at the time of enrollment.
  • Initial maternal health assessment upon confirmation of pregnancy does not preclude participation in the Registry unless a patient tests positive for a medical condition associated with negative pregnancy outcomes (e.g., toxoplasmosis screen and syphilis [venereal disease research laboratory test and rapid plasma reagin test] blood screen) in the opinion of the healthcare provider (HCP).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com
Listed Location Countries Australia,   Canada,   France,   Germany,   Ireland,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01911767
Other Study ID Numbers 109MS402
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biogen
Study Sponsor Biogen
Collaborators Not Provided
Investigators
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date April 2021