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 : December 8, 2020
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Condition or disease | Intervention/treatment |
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Multiple Sclerosis Exposure During Pregnancy | Drug: Dimethyl fumarate Drug: Peginterferon beta-1a |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 1125 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 52 Weeks |
Official Title: | Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry |
Actual Study Start Date : | October 30, 2013 |
Estimated Primary Completion Date : | May 31, 2028 |
Estimated Study Completion Date : | December 31, 2028 |

Group/Cohort | Intervention/treatment |
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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
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Drug: Dimethyl fumarate
Administered as specified in treatment arm.
Other Names:
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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.
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Drug: Peginterferon beta-1a
Administered as specified in treatment arm.
Other Names:
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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.
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- 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)

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911767
Contact: US Biogen Clinical Trial Center | 866-633-4636 | clinicaltrials@biogen.com | |
Contact: Global Biogen Clinical Trial Center | clinicaltrials@biogen.com |
United States, Massachusetts | |
Research Site | Not yet recruiting |
Boston, Massachusetts, United States, 2115 | |
Australia, Victoria | |
Research Site | Recruiting |
Box Hill, Victoria, Australia, 3128 | |
Canada, Massachusetts | |
Research Site | Recruiting |
Cambridge, Massachusetts, Canada, 02139-1955 | |
France | |
Research Site | Not yet recruiting |
Bron CEDEX, Cedex, France, 69677 | |
Germany | |
Research Site | Recruiting |
Bochum, Nordrhein Wesfalen, Germany, 44791 | |
Ireland | |
Research Site | Recruiting |
Dublin 4, Dublin, Ireland, DU | |
Italy | |
Research Site | Recruiting |
Firenze, Italy, 50134 | |
Research Site | Recruiting |
Genova, Italy, 16132 | |
Research Site | Recruiting |
Milano, Italy, 20132 | |
Research Site | Recruiting |
Palermo, Italy, 90146 | |
Research Site | Recruiting |
Roma, Italy, 00152 | |
Poland | |
Research Site | Recruiting |
Białystok, Poland, 15-276 | |
Spain | |
Research Site | Recruiting |
Madrid, Spain, 100 28034 | |
Research Site | Withdrawn |
Malaga, Spain, 29010 | |
United Kingdom | |
Research Site | Recruiting |
Salford, Greater Manchester, United Kingdom, M6 8HD |
Study Director: | Medical Director | Biogen |
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT01911767 |
Other Study ID Numbers: |
109MS402 |
First Posted: | July 30, 2013 Key Record Dates |
Last Update Posted: | December 8, 2020 |
Last Verified: | December 2020 |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Dimethyl Fumarate Dermatologic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |