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

Multiple Sclerosis Clinical Trial

— ReNew  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101776
• Other study ID #: 701068-522
• Status: Completed
• Phase: N/A
• First received: April 8, 2010
• Last updated: August 12, 2014
• Start date: January 2010
• Est. completion date: April 2013

Study information

• Verified date: August 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Australia	Merck Serono Research Site	Adelaide	South Australia
Australia	Merck Serono Research Site	Adelaide	South Australia
Australia	Merck Serono Research Site	Box Hill	Victoria
Australia	Merck Serono Research Site	Bruce	Australian Capital Territory
Australia	Merck Serono Research Site	Burwood	New South Wales
Australia	Merck Serono Research Site	Chatswood	New South Wales
Australia	Merck Serono Research Site	Clayton	Victoria
Australia	Merck Serono Research Site	Fitzroy	Victoria
Australia	Merck Serono Research Site	Footscray	Victoria
Australia	Merck Serono Research Site	Geelong	Victoria
Australia	Merck Serono Research Site	Heidelberg	Victoria
Australia	Merck Serono Research Site	Nedlands	Western Australia
Australia	Merck Serono Research Site	Orange	New South Wales
Australia	Merck Serono Research Site	Perth	Western Australia
Australia	Merck Serono Research Site	Rozelle	New South Wales
Australia	Merck Serono Research Site	Woollongong	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and type of injection site reactions (ISRs)		Month 3, 6, 9 and 12	Yes
Secondary	Number of missed injections of Rebif New Formulation since the previous visit		Month 3, 6, 9 and 12	No
Secondary	Reasons for missed injections of Rebif New Formulation since the previous visit		Month 3, 6, 9 and 12	No
Secondary	Changes in quality of life (MusiQoL)		Baseline visit and at Month 6 and 12	No
Secondary	Number and type (telephone, face-to-face, written) of interactions with nurse support		Month 3, 6, 9 and 12	No
Secondary	Relapse rate		Month 3, 6, 9 and 12.	No
Secondary	Proportion of subjects with dose reductions to 22 mcg as a result of tolerability		Month 3, 6, 9 and 12	Yes