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

This study has been completed.
Sponsor:
Collaborator:
Merck Serono Australia Pty Ltd
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01101776
First received: April 8, 2010
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Drug: Interferon beta-1a (Rebif)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Incidence and type of injection site reactions (ISRs) [ Time Frame: Month 3, 6, 9 and 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of missed injections of Rebif New Formulation since the previous visit [ Time Frame: Month 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
  • Reasons for missed injections of Rebif New Formulation since the previous visit [ Time Frame: Month 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
  • Changes in quality of life (MusiQoL) [ Time Frame: Baseline visit and at Month 6 and 12 ] [ Designated as safety issue: No ]
  • Number and type (telephone, face-to-face, written) of interactions with nurse support [ Time Frame: Month 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
  • Relapse rate [ Time Frame: Month 3, 6, 9 and 12. ] [ Designated as safety issue: No ]
  • Proportion of subjects with dose reductions to 22 mcg as a result of tolerability [ Time Frame: Month 3, 6, 9 and 12 ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: January 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Rebif New Formulation
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101776

Locations
Australia, Australian Capital Territory
Merck Serono Research Site
Bruce, Australian Capital Territory, Australia, 2617
Australia, New South Wales
Merck Serono Research Site
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
Australia, South Australia
Merck Serono Research Site
Adelaide, South Australia, Australia, 5000
Merck Serono Research Site
Adelaide, South Australia, Australia, 5067
Australia, Victoria
Merck Serono Research Site
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
Australia, Western Australia
Merck Serono Research Site
Nedlands, Western Australia, Australia, 6009
Merck Serono Research Site
Perth, Western Australia, Australia, 6151
Sponsors and Collaborators
Merck KGaA
Merck Serono Australia Pty Ltd
Investigators
Study Director: Lynn Sartori Merck Serono Australia Pty Ltd
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01101776     History of Changes
Other Study ID Numbers: 701068-522
Study First Received: April 8, 2010
Last Updated: August 12, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Merck KGaA:
Multiple Sclerosis, relapsing
Rebif New Formulation
Interferon beta-1a

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon beta 1a
Interferon-beta
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on August 28, 2014