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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26127
• EU PAS number:
  EUPAS26126
• Study ID:
  26127
• Official title and acronym:
  Safety and Tolerability Evaluation Profile in RMS Patients Starting Rebif New Formulation (STEP)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  STEP was an observational, non-interventional, post-authorization safety study (PASS), settled in Italy, to evaluate the long-term safety and tolerability of HSA-free Rebif formulation (22 and 44 mcg) in treatment naïve patients with RMS. Secondary objectives were to assess the incidence of anti-interferon beta antibody development both of the binding (BAB) and the neutralizing (NAB) type. Tertiary objective was the evaluation of HSA-free Rebif formulation biological activity by monitoring MxA mRNA biomarker, the efficacy by monitoring EDSS (Expanded Disability Status Scale), FSS (Fatigue Severity Scale) and Multiple Sclerosis Relapse, change in quality of life through the Multiple Sclerosis International Quality of Life (MusiQol) questionnaire and RebiSmart injection device satisfaction through the RebiSmart questionnaire.The study design planned 200 RMS (Relapsing Multiple Sclerosis) treatment naïve patients recruited from around 29 MS Centers throughout Italy.The study duration included an 18-months recruitment period and a 36-months observation period after the last patient enrolment. Each enrolled patient was observed for a 36-months period starting from the first HSA-free administration, except in case of dropout from the study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Centro Riferimento Regionale Sclerosi Multipla (CreSM)

Multiple centres: 29 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 24/09/2009

Study start date

Planned: 07/10/2009

Actual: 22/09/2015

Date of final study report

Planned: 13/10/2015

Actual: 13/10/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Serono S.p.A.

Regulatory

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

Other study registration identification numbers and links

EMR 701068_517