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 visitReasons 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
|