Clinical trial NCT01101776: Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting.
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis, relapsing
Rebif New Formulation
Interferon beta-1a
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Australia Pty Ltd
First posted: 2010-04-12
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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.

Primary outcomes:
measure: Incidence and type of injection site reactions (ISRs)
timeFrame: Month 3, 6, 9 and 12
Secondary outcomes:
measure: Number of missed injections of Rebif New Formulation since the previous visit
timeFrame: Month 3, 6, 9 and 12
measure: Reasons for missed injections of Rebif New Formulation since the previous visit
timeFrame: Month 3, 6, 9 and 12
measure: Changes in quality of life (MusiQoL)
timeFrame: Baseline visit and at Month 6 and 12
measure: Number and type (telephone, face-to-face, written) of interactions with nurse support
timeFrame: Month 3, 6, 9 and 12
measure: Relapse rate
timeFrame: Month 3, 6, 9 and 12.
measure: Proportion of subjects with dose reductions to 22 mcg as a result of tolerability
timeFrame: Month 3, 6, 9 and 12
Other outcomes:
Locations:
city: Bruce
country: Australia
facility: Merck Serono Research Site
state: Australian Capital Territory
city: Burwood
country: Australia
facility: Merck Serono Research Site
state: New South Wales
city: Chatswood
country: Australia
facility: Merck Serono Research Site
state: New South Wales
city: Orange
country: Australia
facility: Merck Serono Research Site
state: New South Wales
city: Rozelle
country: Australia
facility: Merck Serono Research Site
state: New South Wales
city: Woollongong
country: Australia
facility: Merck Serono Research Site
state: New South Wales
city: Adelaide
country: Australia
facility: Merck Serono Research Site
state: South Australia
city: Adelaide
country: Australia
facility: Merck Serono Research Site
state: South Australia
city: Box Hill
country: Australia
facility: Merck Serono Research Site
state: Victoria
city: Clayton
country: Australia
facility: Merck Serono Research Site
state: Victoria
city: Fitzroy
country: Australia
facility: Merck Serono Research Site
state: Victoria
city: Footscray
country: Australia
facility: Merck Serono Research Site
state: Victoria
city: Geelong
country: Australia
facility: Merck Serono Research Site
state: Victoria
city: Heidelberg
country: Australia
facility: Merck Serono Research Site
state: Victoria
city: Nedlands
country: Australia
facility: Merck Serono Research Site
state: Western Australia
city: Perth
country: Australia
facility: Merck Serono Research Site
state: Western Australia
Study officials:
affiliation: Merck Serono Australia Pty Ltd
name: Lynn Sartori
role: STUDY_DIRECTOR
References: