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Study of Utilization Patterns of Dimethyl Fumarate in Germany

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Biogen

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Drug: dimethyl fumarate

Study type

Observational

Funder types

Industry

Identifiers

NCT02969304
109MS409

Details and patient eligibility

About

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.

Full description

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

Enrollment

930 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

930 participants in 2 patient groups

Off-Label
Description:
Any DMF prescription for MS patients \<18 years of age, or for patients diagnosed with non-MS indications, such as psoriasis.
Treatment:
Drug: dimethyl fumarate
On-Label
Description:
Prescriptions for patients who are ≥18 years of age and diagnosed with MS
Treatment:
Drug: dimethyl fumarate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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