Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29058
• EU PAS number:
  EUPAS21305
• Study ID:
  29058
• Official title and acronym:
  Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biogen

Study timelines

Date when funding contract was signed

Planned: 06/10/2014

Actual: 15/10/2014

Study start date

Actual: 01/09/2013

Data analysis start date

Actual: 31/12/2016

Date of final study report

Planned: 02/10/2017

Actual: 20/10/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

Study protocol

Initial protocol

109MS409 Protocol FINAL v1.0 06OCT2014_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

109MS409 NCT02969304https://clinicaltrials.gov/ct2/show/NCT02969304?term=NCT02969304&rank=1