Multiple SclerosisNCT01911767
Biogen Multiple Sclerosis Pregnancy Exposure Registry
An observational study of Multiple Sclerosis and Exposure During Pregnancy, run by Biogen at 15 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Multiple Sclerosis, Exposure During Pregnancy
- What is being tested?
- Dimethyl fumarate and Peginterferon beta-1a
- How many people
- 408 participants
- Where
- 15 sitesin 10 countries
- Study dates
- 30 Oct 2013to 10 Feb 2022
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Within each product cohort, approximately 310 to 375 pregnant women exposed to a Registry-specified Biogen MS product 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. Patients with prenatal testing prior to enrollment (with the exception of a first trimester ultrasound to date the pregnancy) will not be counted towards the 300 prospective pregnancy outcomes.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 10 countries.
15 sites in 10 countries
Italy5 sites
Research Site
Florence, 50134
Research Site
Genova, 16132
Research Site
Milan, 20132
Research Site
Palermo, 90146
Research Site
Roma, 00152
About this study
Official title: Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry
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 dimethyl fumarate, and Pegylated human interferon beta-1a. The secondary objective of the study is to prospectively evaluate pregnancy outcomes in women with MS who were unexposed to disease-modifying therapies (DMTs).
Read the 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.
- Conditions
- Multiple Sclerosis, Exposure During Pregnancy
- Being tested
- Dimethyl fumarate, Peginterferon beta-1a
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyl fumarateDrug
Also called Tecfidera, BG00012, DMF
Administered as specified in treatment arm.
Peginterferon beta-1aDrug
Also called Plegridy, BIIB017
Administered as specified in treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Dimethyl fumarate | |
| 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. Receives: Drug: Peginterferon beta-1a | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Loss
- 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)
Measured: During pregnancy up to 52 weeks post-delivery
Live Birth
- Premature birth (delivered <37 weeks)
- Full-term birth (delivered >=37 weeks)
Measured: During pregnancy up to 52 Weeks Post-Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study start30 Oct 2013
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 408 participants (actual)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911767
- Sponsor's protocol ID
- 109MS402
- Status last verified
- Jun 2022
- First submitted
- 25 Jul 2013
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hellwig K, Rog D, McGuigan C, Houtchens MK, Bruen DR, Mokliatchouk O, Branco F, Peng X, Everage NJ. Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry. Neurol Neuroimmunol Neuroinflamm. 2021 Nov 23;9(1):e1114. doi: 10.1212/NXI.0000000000001114. Print 2022 Jan.
PubMed 34815321
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry
- ClinicalTrials.gov ID
- NCT01911767
- Acronym / sponsor ID
- 109MS402
- Conditions
- Multiple Sclerosis, Exposure During Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2013 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 dimethyl fumarate, and Pegylated human interferon beta-1a. The secondary objective of the study is to prospectively evaluate pregnancy outcomes in women with MS who were unexposed to disease-modifying therapies (DMTs).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dimethyl fumarate | – | Drug: Dimethyl fumarateExposure to dimethyl fumarate since the first day of her last menstrual period (LMP) prior to conception or at any time during pregnancy |
| Peginterferon beta-1a | – | Drug: Peginterferon beta-1aExposure to Peginterferon beta-1a since 17 days prior to the first day of her LMP prior to conception or at any time during pregnancy. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Within each product cohort, approximately 310 to 375 pregnant women exposed to a Registry-specified Biogen MS product 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. Patients with prenatal testing prior to enrollment (with the exception of a first trimester ultrasound to date the pregnancy) will not be counted towards the 300 prospective pregnancy outcomes.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimethyl fumarateAlso: Tecfidera, BG00012, DMFAdministered as specified in treatment arm. | Drug | Dimethyl fumarate |
| Peginterferon beta-1aAlso: Plegridy, BIIB017Administered as specified in treatment arm. | Drug | Peginterferon beta-1a |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 34815321Hellwig K, Rog D, McGuigan C, Houtchens MK, Bruen DR, Mokliatchouk O, Branco F, Peng X, Everage NJ. Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry. Neurol Neuroimmunol Neuroinflamm. 2021 Nov 23;9(1):e1114. doi: 10.1212/NXI.0000000000001114. Print 2022 Jan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
15 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Exposure During Pregnancy, run by Biogen at 15 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy, Spain, United States, Australia, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Loss (time frame: During pregnancy up to 52 weeks post-delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01911767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.