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

NCT01101776 | Completed

• 1 other identifier: 701068-522
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 16

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, relapsing; Rebif New Formulation; Interferon beta-1a

Outcome Measures

Primary Outcomes (1)

• Incidence and type of injection site reactions (ISRs)

  Month 3, 6, 9 and 12

Secondary Outcomes (6)

• Number of missed injections of Rebif New Formulation since the previous visit

  Month 3, 6, 9 and 12

• Reasons for missed injections of Rebif New Formulation since the previous visit

  Month 3, 6, 9 and 12

• Changes in quality of life (MusiQoL)

  Baseline visit and at Month 6 and 12

• Number and type (telephone, face-to-face, written) of interactions with nurse support

  Month 3, 6, 9 and 12

• Relapse rate

  Month 3, 6, 9 and 12.

Interventions

Interferon beta-1a (Rebif) DRUG

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.

Also known as: Rebif New Formulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Ambulatory patients with Multiple Sclerosis who:
• have experienced two or more relapses within the last 2 years. or
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Australia Pty Ltd: collaborator

Study Sites (16)

Merck Serono Research Site

Bruce, Australian Capital Territory, 2617, Australia

Location

Merck Serono Research Site

Burwood, New South Wales, 2134, Australia

Location

Merck Serono Research Site

Chatswood, New South Wales, 2067, Australia

Location

Merck Serono Research Site

Orange, New South Wales, 2800, Australia

Location

Merck Serono Research Site

Rozelle, New South Wales, 2039, Australia

Location

Merck Serono Research Site

Woollongong, New South Wales, 2500, Australia

Location

Merck Serono Research Site

Adelaide, South Australia, 5000, Australia

Location

Merck Serono Research Site

Adelaide, South Australia, 5067, Australia

Location

Merck Serono Research Site

Box Hill, Victoria, 3128, Australia

Location

Merck Serono Research Site

Clayton, Victoria, 3168, Australia

Location

Merck Serono Research Site

Fitzroy, Victoria, 3065, Australia

Location

Merck Serono Research Site

Footscray, Victoria, 3011, Australia

Location

Merck Serono Research Site

Geelong, Victoria, 3220, Australia

Location

Merck Serono Research Site

Heidelberg, Victoria, 3084, Australia

Location

Merck Serono Research Site

Nedlands, Western Australia, 6009, Australia

Location

Merck Serono Research Site

Perth, Western Australia, 6151, Australia

Location

MeSH Terms

Conditions

Multiple Sclerosis; Recurrence

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Lynn Sartori

  Merck Serono Australia Pty Ltd

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 12, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

AU (16)