German Tysabri-Data-Register (Tysabri-Register)

Study identification

• EU PAS number:
  EUPAS7193
• Study ID:
  39827
• Official title and acronym:
  German Tysabri-Data-Register (Tysabri-Register)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The development of immune therapies during the last two decades has focused attention on the appropriate and indication-based usage of the different available treatments by weighting clinical presentation, benefits versus risks and costs. Reliable data on the long-term safety and effectiveness of approved therapies from routine clinical care are not available at the time of drug approval due to known limitations of phase-3 studies, such as certain in- and exclusion criteria, and short or moderate follow-up periods. For the assessment of the incidence, type and characteristics of adverse events in patients treated with Natalizumab in routine clinical care the KKNMS established a therapy register "Tysabri-Register".
• Study status:
  Ongoing

Research institutions and networks

Institutions

Institute of Epidemiology and Social Medicine

Networks

Disease-oriented Competence Network Multiple Sclerosis

Study timelines

Date when funding contract was signed

Actual:26/06/2014

Study start date

Actual:01/10/2014

Date of final study report

Planned:26/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen Idec GmbH

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable