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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Interferon beta-1a (Rebif) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Lynn Sartori, Study Director, Affiliation: Merck Serono Australia Pty Ltd

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Incidence and type of injection site reactions (ISRs)

Secondary outcome:

Number of missed injections of Rebif New Formulation since the previous visit

Reasons for missed injections of Rebif New Formulation since the previous visit

Changes in quality of life (MusiQoL)

Number and type (telephone, face-to-face, written) of interactions with nurse support

Relapse rate

Proportion of subjects with dose reductions to 22 mcg as a result of tolerability

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Merck Serono Research Site, Bruce, Australian Capital Territory 2617, Australia

Merck Serono Research Site, Burwood, New South Wales 2134, Australia

Merck Serono Research Site, Chatswood, New South Wales 2067, Australia

Merck Serono Research Site, Orange, New South Wales 2800, Australia

Merck Serono Research Site, Rozelle, New South Wales 2039, Australia

Merck Serono Research Site, Woollongong, New South Wales 2500, Australia

Merck Serono Research Site, Adelaide, South Australia 5000, Australia

Merck Serono Research Site, Adelaide, South Australia 5067, Australia

Merck Serono Research Site, Box Hill, Victoria 3128, Australia

Merck Serono Research Site, Clayton, Victoria 3168, Australia

Merck Serono Research Site, Fitzroy, Victoria 3065, Australia

Merck Serono Research Site, Footscray, Victoria 3011, Australia

Merck Serono Research Site, Geelong, Victoria 3220, Australia

Merck Serono Research Site, Heidelberg, Victoria 3084, Australia

Merck Serono Research Site, Nedlands, Western Australia 6009, Australia

Merck Serono Research Site, Perth, Western Australia 6151, Australia

Additional Information

Starting date: January 2010
Last updated: August 12, 2014

Page last updated: August 23, 2015

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