NCT01101776

Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting.

Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational multicentric study is planned to assess the tolerability of Rebif New Formulation in an Australian clinical setting by the incidence of injection site reactions (ISRs). The study will allow the comparison of tolerability data with historical data for both Rebif New and classic formulations, and will do so by using the same pre- specified preferred terms of treatment emergent adverse events as done in historical studies. In addition, the study will analyse whether interaction(s) with a nurse impacts tolerability and the impact of Rebif New Formulation on the patient's Quality of Life.

Detailed description

The disease-modifying therapies for multiple sclerosis (MS) aim to slow down the disease process and consequent damage to central nervous system. This study is an open-label, multicentric study planned to assess the tolerability of Rebif New Formulation in an Australian clinical setting by the incidence of ISRs. A total of 100 subjects having relapsing MS across approximately 20 sites in Australia will be enrolled into the study. Subject visits will be scheduled at baseline (month 0) and months 3, 6, 9 and 12 and the data related to demographic factors, disease history, quality of life and adverse drug reactions (ADRs) will be recorded in the case report form (CRF). OBJECTIVES Primary Objective: * To assess the tolerability of Rebif New Formulation in an Australian clinical setting by the incidence of ISRs Secondary Objectives: * Observe the number of and reasons for missed injections of Rebif New Formulation at 3, 6, 9 and 12 months * Assess changes in quality of life \[Multiple Sclerosis International Quality of Life Questionaire (MusiQoL)\] at 6 and 12 months compared to baseline * Number and type (telephone, face-to-face, written) of interactions with nurse support at 3, 6, 9 and 12 months. * Assess relapse rate at 12 months * Assess any differences in tolerability of Rebif New Formulation between subjects who were treatment naïve or on previous MS therapy * Observe the proportion of subjects with dose reductions to 22 mcg as a result of tolerability

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Interferon beta-1a (Rebif)	Interferon beta-1a 44 micrograms (12 MIU) given three times per week (tiw) by subcutaneous injection (SCI). Dose to be reduced to 22 micrograms (6 MIU) tiw by SCI for subjects who cannot tolerate the higher dose.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-04-12
• Last updated: 2014-08-13

Locations

16 sites across 1 country: Australia