A Seven Year Registry
- Ensuring awareness of Pregnancy Registry among Healthcare Providers and Women who become pregnant while receiving treatment for their Multiple Sclerosis in order to capture as many eligible patients as possible
- The Registry is available in 19 countries, with one referring site per country
- Detecting and recording the following outcomes:
- Spontaneous abortion
- Major and minor congenital malformations
- Pregnancy outcome: stillbirth, elective terminations, preterm birth, full-term live birth
- Information on the pregnancy outcome and infant follow-up to approximately one year of age
An international post authorization safety study (PASS) – A prospective, observational cohort study (Registry) of pregnancy outcomes in women with multiple sclerosis (MS) exposed to immuno-modulator treatment in 19 countries: Australia, Austria, Belgium, Canada, Denmark, Czech Republic, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom and USA.
To compare maternal, fetal and infant outcomes in women exposed to immuno-modulator treatment with the outcomes of unexposed external comparison groups.
- An awareness plan was put in place. All Registry awareness activities will be targeted to HCPs in participating countries. The Registry does not recruit patients directly
- Used a Registry Coordinating Center in North America and a Coordinating Registry Physician (CRP) model in Rest of World by engaging Syneos Health’s expertise in Registry Start-Up across 19 countries
- Collection and analysis of data from multiple data sources
- Achieved increased level of awareness based on number of enrolled cases in the Registry
- Fit-for-purpose Pregnancy Registry model based on healthcare provider and local country requirements
- Established scientific advisory board including leadership from the Syneos Health Epidemiology Team to evaluate all reported pregnancy data