Patient real-world clinical, neurological, tolerability, and safety outcomes for Tecfidera® and Rebif®: A retrospective study (PROTRACT)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26260
• EU PAS number:
  EUPAS12652
• Study ID:
  26260
• Official title and acronym:
  Patient real-world clinical, neurological, tolerability, and safety outcomes for Tecfidera® and Rebif®: A retrospective study (PROTRACT)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  The purpose of this study is to evaluate the proportion of patients who demonstrate nomedical need to discontinue therapy among DMT-naïve patients with relapsing forms ofmultiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bidbased on real-world data.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Planned: 31/08/2015

Actual: 27/10/2015

Study start date

Planned: 18/02/2016

Actual: 02/03/2016

Date of final study report

Planned: 30/04/2017

Actual: 20/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

EMD Serono

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable