Clinical Trials

The Multi-National Tecfidera Pregnancy Exposure Registry in MS

Type of Study/Intervention

Observational

Recruitment Status

Recruiting

Form of MS

Relapsing remitting MS

Brief summary

To collect and evaluate safety data on TecfideraTM (dimethyl fumarate) exposure during pregnancy.

Tecfidera has not been tested in clinical trials in pregnant  women and the side-effects are unknown. Tecfidera is not recommended for pregnant women however, this study will capture vital data on pregnancies that may have been inadvertently exposed to Tecfidera.

The purpose of the Multi-National Tecfidera Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess side-effects in pregnant women and in the offspring of women exposed to Tecfidera during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, foetal, and infant outcomes and compare it with reference populations.

Inclusion criteria

Any woman with a diagnosis of MS, who is currently pregnant and has been exposed to Tecfidera during the pregnancy.

Anticipated start date

June 2014

Recruitment contacts

Daniel Merlo
Eastern Health MS Service
Level 2, 5 Arnold St Box Hill VIC 3128
Email: [email protected]
Phone: 03 9895 4914

Further details

Full details of the trial can be found on the ClinicalTrials.gov registry.

Region

All States and Territories

Last updated

August 2016

Contact Us

We're not around right now. But you can send us an email and we'll get back to you, asap.

Start typing and press Enter to search