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

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  REBIF

  TECFIDERA
• Medical condition to be studied:
  Relapsing-remitting multiple sclerosis

Population studied

• Short description of the study population:
  Patients who demonstrate no medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Relapsing-remitting multiple sclerosis patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The primary objective is to evaluate the proportion of patients who demonstrate no medicalneed to discontinue therapy among Disease Modifying Therapy (DMT)-naïve patients withrelapsing forms of Multiple Sclerosis (MS) after 1 year of treatment with Rebif 44 mcg tiw orwith Tecfidera 240 mg bid.
• Outcomes:
  The primary outcome is "No medical need to discontinue therapy" defined as:1. No Evidence of Disease Activity (NEDA-2): A composite measure of (1) absence ofrelapses AND (2) no new or enlarging T2 or T1 gadolinium-enhancing lesions on MagneticResonance Imaging over the follow-up period.2. No discontinuation due to disease activity, tolerability, or adverse events during thefollow-up, Evaluation of:1. Clinical and/or neurological differences (e.g. relapses, neurological lesions) between thetwo treatment groups.2. Proportion of individuals within each treatment group who discontinued treatment due- to tolerability- to adverse events- to disease activity
• Data analysis plan:
  observational, retrospective, longitudinal cohort study to assess effectiveness in the realworld