Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Dimethyl fumarate will not be provided to participants as a part of this study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Off-Label | Any DMF prescription for MS patients <18 years of age, or for patients diagnosed with non-MS indications, such as psoriasis. |
| |
| On-Label | Prescriptions for patients who are ≥18 years of age and diagnosed with MS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug | Off-Label Use: All participants <18 years of age and participants without an MS diagnosis who are prescribed dimethyl fumarate On-Label Use: All participants >18 years of age with an MS diagnosis who are prescribed dimethyl fumarate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Retrospective analysis of a research database, which contains German sick fund claims, to assess the usage of dimethyl fumarate in Germany. The research database is comprised of German sick fund data, which is compiled by Gesundheitsforen Leipzig (GFL). This GFL database currently contains sick fund claims data for approximately 4 million patients, which accounts for approximately 5-6% of the total sick fund population in Germany.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Leipzig | Saxony | 04109 | Germany |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Duration of therapy in participants newly initiating dimethyl fumarate treatment | 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 |
| Medical history of dimethyl fumarate users | 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D009930 |
| Organic Chemicals |