NCT02969304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
930

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 30, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

October 21, 2016

Last Update Submit

July 18, 2017

Conditions

Multiple Sclerosis

Keywords

TecfideraOff-labelUtilization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Demographic characteristics of dimethyl fumarate users

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

  • Prescription drug history of dimethyl fumarate users

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

  • Duration of therapy in participants newly initiating dimethyl fumarate treatment

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

  • 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

  • Medical history of dimethyl fumarate users

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

  • +1 more secondary outcomes

Study Arms (2)

Off-Label

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

Drug: dimethyl fumarate

On-Label

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

Drug: dimethyl fumarate

Interventions

dimethyl fumarateDRUG

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

Also known as: Tecfidera, DMF, BG00012
Off-LabelOn-Label

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Leipzig, Saxony, 04109, Germany

Location

MeSH Terms

Conditions

Multiple SclerosisPatient Acceptance of Health Care

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

FumaratesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2016

First Posted

November 21, 2016

Study Start

December 30, 2016

Primary Completion

March 2, 2017

Study Completion

March 2, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

DE(1)