Study of Utilization Patterns of Dimethyl Fumarate in Germany

NCT ID: NCT02969304

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

930 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-30

Study Completion Date

2017-03-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Off-Label

Any DMF prescription for MS patients \<18 years of age, or for patients diagnosed with non-MS indications, such as psoriasis.

dimethyl fumarate

Intervention Type 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

On-Label

Prescriptions for patients who are ≥18 years of age and diagnosed with MS

dimethyl fumarate

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tecfidera, DMF, BG00012

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* New users of dimethyl fumarate will be included in the analysis

Exclusion Criteria

* Patients for which data is not available for the 6 months period prior to the index date (baseline observational period)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Leipzig, Saxony, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

109MS409

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.