Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)
The rationale of this study is to assess the safety profile, efficacy and adherence to Rebif® New Formulation in real life settings with a multinational approach, as well as the impact of this improved formulation (with regards to adverse events [AEs]) to subjects' adherence.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||An International, Multi Centre, Prospective, Observational Study of Safety, Tolerability and Adherence of Patients With Relapsing Remitting Multiple Sclerosis Administered Interferon Beta-1a (Rebif® New Formulation) in Real Life Settings|
- Proportion of subjects with injection site reactions (ISRs) [ Time Frame: Baseline, month 6 and month 12 ] [ Designated as safety issue: Yes ]
- proportion of subjects with AEs and with specific categories of AEs; proportion and reasons of missed injections, annual relapse rate, proportion of relapse-free subjects from baseline, time to first relapse [ Time Frame: Baseline, month 6 and month 12 ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Drug: Rebif® New Formulation
This international, multicentric, prospective, observational study is being conducted to assess the safety profile, efficacy and adherence to Rebif® New Formulation in real life settings in subjects with relapsing remitting multiple sclerosis (RRMS), as well as the impact of this improved formulation (with regards to adverse events [AEs]) to subjects' adherence. Three hundred and fifty subjects from approximately 80 sites across seven countries will be enrolled in the study. Subjects will be treated with IFN beta-1a (Rebif® New Formulation) in real life settings according to the clinical and paraclinical course and laboratory findings as routinely evaluated by the physician. Data related to AEs; subjects' adherence to treatment, reasons for treatment discontinuation; number and reasons of missed injections; and the clinical and paraclinical data on efficacy regarding relapses will be captured. Data will be reported prospectively throughout the duration of the study (12 months) at two visits (at month 6 and month 12) following the initial visit; at baseline, data can be recorded retrospectively from the subjects' medical file. All the data will be evaluated descriptively.
- To assess the local tolerability of Rebif® New Formulation in real life settings with a multinational approach.
- To assess the safety profile, subjects' adherence to and efficacy of Rebif® New Formulation
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080027
|Neurology Clinic, General Hospital of Thessaloniki "G. Papanikolaou"|
|Thessaloniki, Greece, 57010|
|Study Director:||Michalis Arvanitis, MD, MSc||Merck A.E., Greece|