Clinical trial NCT02969304: Study of Utilization Patterns of Dimethyl Fumarate in Germany
Official title: Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Tecfidera
Off-label
Utilization
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-11-21
Enrollment: 930
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Key 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.

Primary outcomes:
measure: Proportion of dimethyl fumarate use that is prescribed "on-label" versus "off-label" in Germany
timeFrame: Up to 18 months after market introduction of dimethyl fumarate in Germany
Secondary outcomes:
measure: Demographic characteristics of dimethyl fumarate users
timeFrame: Up to 18 months after market introduction of dimethyl fumarate in Germany
measure: Prescription drug history of dimethyl fumarate users
timeFrame: Up to 18 months after market introduction of dimethyl fumarate in Germany
measure: Duration of therapy in participants newly initiating dimethyl fumarate treatment
timeFrame: Up to 18 months after market introduction of dimethyl fumarate in Germany
measure: Number of medical specialists prescribing dimethyl fumarate as identified according to specialty-specific billing codes at outpatient visits.
timeFrame: Up to 18 months after market introduction of dimethyl fumarate in Germany
measure: Medical history of dimethyl fumarate users
timeFrame: Up to 18 months after market introduction of dimethyl fumarate in Germany
measure: Concomitant medication use of dimethyl fumarate users
timeFrame: Up to 18 months after market introduction of dimethyl fumarate in Germany
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Research Site
state: Saxony
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: