Skip to main content
OpenTrials
Completed

NCT Number: NCT02969304

Study of Utilization Patterns of Dimethyl Fumarate in Germany

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Health Behavior Immune System Diseases Nervous System Diseases Patient Acceptance of Health Care Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Leipzig, Saxony, 04109, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Tecfidera, DMF, BG00012

Primary outcomes

  1. Proportion of dimethyl fumarate use that is prescribed "on-label" versus "off-label" in Germany

    Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany

Secondary outcomes

  1. Demographic characteristics of dimethyl fumarate users

    Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany

  2. Prescription drug history of dimethyl fumarate users

    Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany

  3. Duration of therapy in participants newly initiating dimethyl fumarate treatment

    Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany

  4. Number of medical specialists prescribing dimethyl fumarate as identified according to specialty-specific billing codes at outpatient visits.

    Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany

  5. Medical history of dimethyl fumarate users

    Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany

  6. Concomitant medication use of dimethyl fumarate users

    Time frame: Up to 18 months after market introduction of dimethyl fumarate in Germany

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2016
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.