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

August 12, 2014 updated by: Merck KGaA, Darmstadt, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Bruce, Australian Capital Territory, Australia, 2617
        • Merck Serono Research Site
    • New South Wales
      • Burwood, New South Wales, Australia, 2134
        • Merck Serono Research Site
      • Chatswood, New South Wales, Australia, 2067
        • Merck Serono Research Site
      • Orange, New South Wales, Australia, 2800
        • Merck Serono Research Site
      • Rozelle, New South Wales, Australia, 2039
        • Merck Serono Research Site
      • Woollongong, New South Wales, Australia, 2500
        • Merck Serono Research Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Merck Serono Research Site
      • Adelaide, South Australia, Australia, 5067
        • Merck Serono Research Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Merck Serono Research Site
      • Clayton, Victoria, Australia, 3168
        • Merck Serono Research Site
      • Fitzroy, Victoria, Australia, 3065
        • Merck Serono Research Site
      • Footscray, Victoria, Australia, 3011
        • Merck Serono Research Site
      • Geelong, Victoria, Australia, 3220
        • Merck Serono Research Site
      • Heidelberg, Victoria, Australia, 3084
        • Merck Serono Research Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Merck Serono Research Site
      • Perth, Western Australia, Australia, 6151
        • Merck Serono Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with MS who have experienced two or more relapses within last 2 years and to be treated with Rebif New Formulation in Australia.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and type of injection site reactions (ISRs)
Time Frame: Month 3, 6, 9 and 12
Month 3, 6, 9 and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of missed injections of Rebif New Formulation since the previous visit
Time Frame: Month 3, 6, 9 and 12
Month 3, 6, 9 and 12
Reasons for missed injections of Rebif New Formulation since the previous visit
Time Frame: Month 3, 6, 9 and 12
Month 3, 6, 9 and 12
Changes in quality of life (MusiQoL)
Time Frame: Baseline visit and at Month 6 and 12
Baseline visit and at Month 6 and 12
Number and type (telephone, face-to-face, written) of interactions with nurse support
Time Frame: Month 3, 6, 9 and 12
Month 3, 6, 9 and 12
Relapse rate
Time Frame: Month 3, 6, 9 and 12.
Month 3, 6, 9 and 12.
Proportion of subjects with dose reductions to 22 mcg as a result of tolerability
Time Frame: Month 3, 6, 9 and 12
Month 3, 6, 9 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono Australia Pty Ltd

Investigators

  • Study Director: Lynn Sartori, Merck Serono Australia Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 12, 2010

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 701068-522

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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