An immune therapy register for the improvement of drug safety and treatment of patients with Multiple Sclerosis (REGIMS)

Study identification

• EU PAS number:
  EUPAS7892
• Study ID:
  29641
• Official title and acronym:
  An immune therapy register for the improvement of drug safety and treatment of patients with Multiple Sclerosis (REGIMS)
• 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 an immune therapy except Natalizumab in routine clinical care the KKNMS established a "immune therapy register for the improvement of drug safety and treatment of patients with Multiple Sclerosis" (REGIMS).
• Study status:
  Planned

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

Planned:01/01/2013

Study start date

Planned:01/01/2014

Data analysis start date

Planned:01/01/2015

Date of final study report

Planned:30/12/2019

Sources of funding

Other

More details on funding

BMBF

Regulatory

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