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NCT01911767 · ClinicalTrials.gov registry record
Biogen Multiple Sclerosis Pregnancy Exposure Registry
A clinical trial, sponsored by Biogen.
- Completed
- Registry status
- 408
- Enrollment target
NCT01911767: Completed study, sponsored by Biogen.
NCT01911767 is a clinical trial that has completed, run by Biogen. The registered enrollment target is 408 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01911767 has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- 408 participants
- Enrollment target
Study 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).
Primary Outcome
* 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)
Interventions
- DRUG Dimethyl fumarate
- DRUG Peginterferon beta-1a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2013-10-30 |
| Est. Completion | 2022-02-10 |
What the finished NCT01911767 record still lists
NCT01911767 is an observational study that tracks outcomes without assigning an intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Dimethyl fumarate is the first listed.
NCT01911767 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01911767 about?
NCT01911767 is a clinical study titled "Biogen 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 d...
What is the current status of trial NCT01911767?
This trial is currently completed. The enrollment target is 408 participants. The study started on 2013-10-30. Estimated completion is 2022-02-10.
What interventions are being tested in trial NCT01911767?
The interventions under investigation include: Dimethyl fumarate (DRUG), Peginterferon beta-1a (DRUG).
Who is sponsoring clinical trial NCT01911767?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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