NCT01080027

Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 254 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. OBJECTIVES Primary objective * To assess the local tolerability of Rebif® New Formulation in real life settings with a multinational approach. Secondary objectives * To assess the safety profile, subjects' adherence to and efficacy of Rebif® New Formulation

Conditions

• Multiple Sclerosis, Relapsing Remitting

Interventions

Type	Name	Description
DRUG	Rebif® New Formulation	The recommended dose of Rebif® is 22 or 44 μg administered three times per week by subcutaneous injection.

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-03-03
• Last updated: 2014-07-31

Locations

1 site across 1 country: Greece