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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01911767




Registration number
NCT01911767
Ethics application status
Date submitted
25/07/2013
Date registered
30/07/2013
Date last updated
17/08/2020

Titles & IDs
Public title
Biogen Multiple Sclerosis Pregnancy Exposure Registry
Scientific title
Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry
Secondary ID [1] 0 0
109MS402
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Exposure During Pregnancy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Dimethyl fumarate
Treatment: Drugs - Peginterferon beta-1a

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

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.

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.


Treatment: Drugs: Dimethyl fumarate
Administered as specified in treatment arm.

Treatment: Drugs: Peginterferon beta-1a
Administered as specified in treatment arm.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
During pregnancy up to 52 weeks post-delivery
Primary outcome [2] 0 0
Live Birth - Premature birth (delivered <37 weeks)
Full-term birth (delivered >=37 weeks)
Timepoint [2] 0 0
During pregnancy up to 52 Weeks Post-Delivery

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
France
State/province [2] 0 0
Cedex
Country [3] 0 0
Germany
State/province [3] 0 0
Nordrhein Wesfalen
Country [4] 0 0
Ireland
State/province [4] 0 0
Dublin
Country [5] 0 0
Italy
State/province [5] 0 0
Firenze
Country [6] 0 0
Italy
State/province [6] 0 0
Genova
Country [7] 0 0
Italy
State/province [7] 0 0
Milano
Country [8] 0 0
Italy
State/province [8] 0 0
Palermo
Country [9] 0 0
Italy
State/province [9] 0 0
Roma
Country [10] 0 0
Poland
State/province [10] 0 0
Bialystok
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
Spain
State/province [12] 0 0
Malaga
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Greater Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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).
Trial website
https://clinicaltrials.gov/show/NCT01911767
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US Biogen Clinical Trial Center
Address 0 0
Country 0 0
Phone 0 0
866-633-4636
Fax 0 0
Email 0 0
clinicaltrials@biogen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01911767