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Biogen Multiple Sclerosis Pregnancy Exposure Registry

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis; Exposure During Pregnancy

Intervention: dimethyl fumarate (Drug); Peginterferon beta-1a (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Overall contact:
Biogen, Email: clinicaltrials@biogen.com

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 dimtheyl fumarate and Pegylated human interferon beta-1a.

Clinical Details

Official title: Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Negative birth outcomes, including spontaneous abortions and birth defects.

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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 14 days prior to the first day of her LMP prior

to conception or at any time during pregnancy. Key Exclusion Criteria:

- Prenatal testing that could provide knowledge of the outcome of pregnancy must not

have been performed prior to the time of enrollment (e. g., alpha fetoprotein, sonography, amniocentesis). However, 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., syphilis) in the opinion of the health care professional.

- The outcome of the pregnancy must not be known at the time of enrollment.

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

Locations and Contacts

Biogen, Email: clinicaltrials@biogen.com

Research Site, Bochum 44791, Germany; Recruiting

Research Site, Dublin 4, Ireland; Not yet recruiting

Research Site, Firenze, Italy; Not yet recruiting

Research Site, Malaga S/N 29010, Spain; Not yet recruiting

Research Site, Salford M6 8HD, United Kingdom; Recruiting

Research Site, Maitland, Florida 32751, United States; Not yet recruiting

Research Site, Box Hill, Victoria, Australia; Recruiting

Research Site, Reston, Virginia 20191, United States; Recruiting

Additional Information

Starting date: June 2013
Last updated: July 23, 2015

Page last updated: August 23, 2015

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