Betaseron Pregnancy Registry

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
INC Research
ClinicalTrials.gov Identifier:
NCT00317564
First received: April 21, 2006
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

This is a prospective, observational, registration and follow-up study of women exposed to Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The Betaseron® Pregnancy Registry is designed to determine whether there is an increased risk or a pattern of birth defects in the offspring of women exposed to Betaseron® at conception and during pregnancy compared to rates from women in the general US population. Secondarily, the Registry will examine rates of spontaneous abortions and other negative pregnancy outcomes in this population. This study will be conducted in the United States (US). The Betaseron® Pregnancy Registry is sponsored by Bayer HealthCare Pharmaceuticals and is managed by the Post Approval & Strategic Services group at INC Research, LLC. The scientific conduct and analysis of the Registry will be overseen by an Independent Data Safety Monitoring Board (IDSMB) consisting of external specialists in teratology, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).


Condition Phase
Birth Defects
Pregnancy Complications
Multiple Sclerosis
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Betaseron Pregnancy Registry

Resource links provided by NLM:


Further study details as provided by INC Research:

Enrollment: 113
Study Start Date: April 2006
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Because informed consent is required, the Registration process must be initiated by the patient. An HCP who contacts the Registry may request an authorization for release of medical information packet or have the eligible patient contact the Registry directly. Once an eligible subject provides consent and permission to obtain information from her HCP, the Registry will contact the obstetric HCP and obtain information on demographics, history of previous pregnancies, maternal risk factors, pregnancy outcome, and neonatal health. Data will be collected from the maternal HCP at enrollment, during the second trimester (around week 20), and at outcome. Data on live born infants will be collected from the pediatrician at 4 months of age. If a birth defect is reported, targeted follow-up may be conducted.

NOTE: This study has previously been posted by Berlex, Inc. which has since been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of this pregnancy registry.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

US only

Criteria

Inclusion Criteria:

The subjects must meet the following criteria for registration:

  • Enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test)
  • Diagnosed with MS prior to or during the current pregnancy
  • Exposed to Betaseron® on or after the first day of the patient's last menstrual period
  • Provide verbal consent to participate in the Registry
  • Verbally provide contact information for herself, her HCP, and the infant's HCP (as applicable)
  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: NCT00317564

Locations
United States, North Carolina
INC Research
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
INC Research
Bayer
Investigators
Principal Investigator: Jessica Albano, PhD, MS INC Research
Study Director: Vicki Poon, MPH Bayer
Study Director: Mark Rametta, D.O., FACOI, FACP Bayer
Study Director: Karen Maloney Marini Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: INC Research
ClinicalTrials.gov Identifier: NCT00317564     History of Changes
Other Study ID Numbers: 308740
Study First Received: April 21, 2006
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by INC Research:
Birth Defects
High Risk Pregnancy
Multiple Sclerosis

Additional relevant MeSH terms:
Pregnancy Complications
Sclerosis
Multiple Sclerosis
Congenital Abnormalities
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014