Multiple Sclerosis Clinical Trial
Official title:
Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry
NCT number | NCT01911767 |
Other study ID # | 109MS402 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 30, 2013 |
Est. completion date | February 10, 2022 |
Verified date | June 2022 |
Source | Biogen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient 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).
Status | Completed |
Enrollment | 408 |
Est. completion date | February 10, 2022 |
Est. primary completion date | February 10, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Research Site | Box Hill | Victoria |
Canada | Research Site | Cambridge | Massachusetts |
France | Research Site | Bron CEDEX | Cedex |
Germany | Research Site | Bochum | Nordrhein Wesfalen |
Ireland | Research Site | Dublin | |
Italy | Research Site | Firenze | |
Italy | Research Site | Genova | |
Italy | Research Site | Milano | |
Italy | Research Site | Palermo | |
Italy | Research Site | Roma | |
Poland | Research Site | Bialystok | |
Spain | Research Site | Madrid | |
Spain | Research Site | Malaga | |
United Kingdom | Research Site | Salford | Greater Manchester |
United States | Research Site | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Biogen |
United States, Australia, Canada, France, Germany, Ireland, Italy, Poland, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
During pregnancy up to 52 weeks post-delivery | |
Primary | Live Birth | Premature birth (delivered <37 weeks)
Full-term birth (delivered >=37 weeks) |
During pregnancy up to 52 Weeks Post-Delivery |
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