Biogen Multiple Sclerosis Pregnancy Exposure Registry

• Register: ClinicalTrials.gov
• Last refreshed on: 27 June 2022
• Main ID: NCT01911767
• Date of registration: 25/07/2013
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Biogen Multiple Sclerosis Pregnancy Exposure Registry
• Scientific title: Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry
• Date of first enrolment: October 30, 2013
• Target sample size: 408
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01911767
• Study type: Observational [Patient Registry]

Countries of recruitment

Australia, Canada, France, Germany, Ireland, Italy, Poland, Spain, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Exposure During Pregnancy

Multiple Sclerosis

Intervention(s)

Drug: Peginterferon beta-1a

Drug: Dimethyl fumarate

Primary Outcome(s)

Pregnancy Loss [Time Frame: During pregnancy up to 52 weeks post-delivery]

Live Birth [Time Frame: During pregnancy up to 52 Weeks Post-Delivery]

Secondary ID(s)

109MS402

Source(s) of Monetary Support

Please refer to primary and secondary sponsors