Safety and Tolerability Evaluation Profile in RMS Patients Starting Rebif New Formulation (STEP)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post-authorization safety study (PASS)

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Treatment naïve patients with Relapsing Multiple Sclerosis (RMS).
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Relapsing Multiple Sclerosis (RMS) patients
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The main objective of this study is to evaluate the long-term safety and tolerability of HSA-free Rebif formulation (22 and 44 mcg) in treatment naïve patients with RMS.
• Outcomes:
  The primary outcome variable was the proportion of patients with Adverse Drug Reactions (ADRs). An ADR was defined as any response to a medicinal product which was noxious and unintended and a causal relationship between a medicinal product and an adverse event was at least a reasonable possibility. Secondary outcomes:Proportion of patients with specific categories of ADRs. Proportion of patients with BAB positivity. Proportion of patients with NAB positivity.Tertiary outcomes: MxA mRNA levels,EDSS score,FSS (Fatigue Severity Scale) score,MS Relapse incidence, MusiQoL questionnaire overall score, RebiSmart questionnaire score.
• Data analysis plan:
  The statistical software SAS® (version 8.0 or later) was used to conduct the statistical analysis. The following data sets were used for analysis and presentation of the study data: • All-subjects-enrolled set (ASE) – all enrolled subjects • All-subjects-treated set (AST) – all subjects in the ASE who took at least one dose of HSA-free • Full-analysis set (FAS) – all subjects in the AST who had at least one valid postbaseline assessment of the efficacy/quality of life variables • Per-protocol set (PPS) – all subjects in the FAS who: - did not violate any inclusion criterion or exclusion criterion- had good compliance with the study treatment (≥80%) - did not have any other deviation that was considered relevant from the clinical/statistical point of view.