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 is ongoing, but not recruiting participants.
Sponsor:
Merck KGaA
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 20, 2012
Last verified: August 2012
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
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: | 50 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
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:
- 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.
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
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 20, 2012 |
| 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 |
Interferons Interferon beta 1a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 23, 2013