Study of Utilization Patterns of Dimethyl Fumarate in Germany

Multiple Sclerosis Clinical Trial

Official title:

Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969304
• Other study ID #: 109MS409
• Status: Completed
• Phase: N/A
• First received: October 21, 2016
• Last updated: July 18, 2017
• Start date: December 30, 2016
• Est. completion date: March 2, 2017

Study information

• Verified date: July 2017
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Dimethyl fumarate will not be provided to participants as a part of this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 930
• Est. completion date: March 2, 2017
• Est. primary completion date: March 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• dimethyl fumarate
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

Locations

Country	Name	City	State
Germany	Research Site	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demographic characteristics of dimethyl fumarate users		Up to 18 months after market introduction of dimethyl fumarate in Germany
Secondary	Prescription drug history of dimethyl fumarate users		Up to 18 months after market introduction of dimethyl fumarate in Germany
Secondary	Duration of therapy in participants newly initiating dimethyl fumarate treatment		Up to 18 months after market introduction of dimethyl fumarate in Germany
Secondary	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
Secondary	Medical history of dimethyl fumarate users		Up to 18 months after market introduction of dimethyl fumarate in Germany
Secondary	Concomitant medication use of dimethyl fumarate users		Up to 18 months after market introduction of dimethyl fumarate in Germany