A Study Assessing the U.S. Post-Marketing Safety Profile of Rebif® in comparison with its U.S. Prescribing Information

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  REBIF
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Short description of the study population:
  Adult subjects with relapsing-remitting forms of multiple sclerosis receiving treatment of Rebif, a drug approved by the US FDA in 2002.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Multiple Sclerosis patients
• Estimated number of subjects:
  8107

Study design details

• Main study objective:
  To characterize the post-marketing safety profile of Rebif with regards to its safety profile as presented in its U.S. label.
• Outcomes:
  Incidence (n, %, per 100,000 patients-year) of specific events as set forth in the April 2014U.S. Prescribing Information for Rebif:1. Warnings & Precautions2. Adverse Drug Reactions3. Postmarketing Experience sections
• Data analysis plan:
  Events of interest will be described at MedDRA Preferred Term level and further categorized into System Organ Classes. Descriptive analysis will be conducted and incidence rates with 95% confidence intervals per 100 person-years of labeled AEs will be calculated.