Study of Utilization Patterns of Dimethyl Fumarate in Germany
- Registration Number
- NCT02969304
- Lead Sponsor
- Biogen
- Brief Summary
The primary objective of this study is to estimate the proportion of DMF use that is prescribed "on-label" versus "off-label". The secondary objectives are: To describe the demographic characteristics and medical history of DMF users; To describe prescription drug history and concomitant medication use of DMF users; To describe the duration of therapy in participants newly initiating DMF treatment; To describe the medical specialties of DMF prescribers.
- Detailed Description
Dimethyl fumarate will not be provided to participants as a part of this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 930
Inclusion Criteria
- New users of dimethyl fumarate will be included in the analysis
Key
Exclusion Criteria
- Patients for which data is not available for the 6 months period prior to the index date (baseline observational period)
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description On-Label dimethyl fumarate Prescriptions for patients who are ≥18 years of age and diagnosed with MS Off-Label dimethyl fumarate Any DMF prescription for MS patients \<18 years of age, or for patients diagnosed with non-MS indications, such as psoriasis.
- Primary Outcome Measures
Name Time Method Proportion of dimethyl fumarate use that is prescribed "on-label" versus "off-label" in Germany Up to 18 months after market introduction of dimethyl fumarate in Germany
- Secondary Outcome Measures
Name Time Method Duration of therapy in participants newly initiating dimethyl fumarate treatment Up to 18 months after market introduction of dimethyl fumarate in Germany Concomitant medication use of dimethyl fumarate users Up to 18 months after market introduction of dimethyl fumarate in Germany Demographic characteristics of dimethyl fumarate users Up to 18 months after market introduction of dimethyl fumarate in Germany Prescription drug history of dimethyl fumarate users Up to 18 months after market introduction of dimethyl fumarate in Germany Medical history of dimethyl fumarate users Up to 18 months after market introduction of dimethyl fumarate in Germany Number of medical specialists prescribing dimethyl fumarate as identified according to specialty-specific billing codes at outpatient visits. Up to 18 months after market introduction of dimethyl fumarate in Germany
Trial Locations
- Locations (1)
Research Site
🇩🇪Leipzig, Saxony, Germany