Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Tecfidera (Dimethyl Fumarate) Pregnancy Exposure Registry (TEC-GISTRY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01911767
First received: July 25, 2013
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

The primary objective of the study is to prospectively evaluate pregnancy outcomes in women with multiple sclerosis who were exposed to dimethyl fumarate since the first day of their last menstrual period prior to conception or at any time during pregnancy.


Condition
Multiple Sclerosis
Exposure During Pregnancy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
Official Title: Tecfidera (Dimethyl Fumarate) Pregnancy Exposure Registry

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Negative birth outcomes, including spontaneous abortions and birth defects. [ Time Frame: During pregnancy up to 12 weeks post-delivery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 375
Study Start Date: June 2013
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Detailed Description:

The Tecfidera (dimethyl fumarate) Pregnancy Registry is a prospective, observational registry designed to evaluate pregnancy outcomes in women with multiple sclerosis (MS) who were exposed to dimethyl fumarate (DMF) since the first day of their last menstrual period prior to conception or at any time during pregnancy. Women of childbearing potential are a considerable segment of the patient population affected by MS and are likely to be exposed to DMF around the time of conception and during pregnancy. Although the data are very limited, there is currently no evidence of increased risk of fetal abnormalities or adverse pregnancy outcomes associated with gestational exposure to DMF during the first trimester. Therefore, it is important to evaluate, in a global pregnancy registry, how DMF exposure 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 and 12 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

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

Approximately 310 to 375 pregnant DMF exposed women 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.

Criteria

Inclusion Criteria:

  • Patient consent
  • Patient has a diagnosis of MS.
  • Documentation that the patient was exposed to DMF since the first day of her LMP prior to conception or at any time during pregnancy.

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.
  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: NCT01911767

Contacts
Contact: Biogen Idec neurologyclinicaltrials@biogenidec.com

Locations
United States, Massachusetts
Registry participation is worldwide and not limited to this facility; facilities not yet active may enroll upon identification of a patient Recruiting
Cambridge, Massachusetts, United States
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01911767     History of Changes
Other Study ID Numbers: 109MS402
Study First Received: July 25, 2013
Last Updated: August 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Dimethyl fumarate
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014