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
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono Australia Pty Ltd
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Ambulatory patients with Multiple Sclerosis who:

1. have experienced two or more relapses within the last 2 years. or

2. are not tolerating their current MS therapy.

• Patients 18 years of age or over.

• Patients with Expanded Disability Status Scale (EDSS) score <6.0.

• Patients who have given informed consent to participate in the study.

Exclusion Criteria:

• Subjects with diagnosis of any other form of MS other than relapsing MS.

• Contra-indicated medical conditions for IFN beta-1a as defined in the Product Information i.e: women who are or plan to become pregnant whilst on therapy; subject with severe depressive disorders and/or suicidal ideation and; epileptic subjects with seizures not adequately controlled by treatment

• Subjects with a known hypersensitivity to natural or recombinant interferon beta, mannitol, poloxamer, methionine, sodium acetate buffer or benzyl alcohol.

• Subjects who are pregnant and/or breastfeeding.

• Subjects currently on Rebif New Formulation.

• Subjects currently experiencing a relapse.