Multiple SclerosisReNewNCT01101776
Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting.
An observational study of Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 16 sites in Australia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1a (Rebif)
- Type of treatment
- Injection or infusion
- How many people
- 49 participants
- Where
- 16 sitesAustralia
- Study dates
- Jan 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Australia16 sites
Merck Serono Research Site
Adelaide, South Australia, 5000
Merck Serono Research Site
Adelaide, South Australia, 5067
Merck Serono Research Site
Box Hill, Victoria, 3128
Merck Serono Research Site
Bruce, Australian Capital Territory, 2617
Merck Serono Research Site
Burwood, New South Wales, 2134
Merck Serono Research Site
Chatswood, New South Wales, 2067
Merck Serono Research Site
Clayton, Victoria, 3168
Merck Serono Research Site
Fitzroy, Victoria, 3065
Merck Serono Research Site
Footscray, Victoria, 3011
Merck Serono Research Site
Geelong, Victoria, 3220
Merck Serono Research Site
Heidelberg, Victoria, 3084
Merck Serono Research Site
Nedlands, Western Australia, 6009
Merck Serono Research Site
Orange, New South Wales, 2800
Merck Serono Research Site
Perth, Western Australia, 6151
Merck Serono Research Site
Rozelle, New South Wales, 2039
Merck Serono Research Site
Woollongong, New South Wales, 2500
About this study
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
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.
Read the 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
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1a (Rebif)
- Keywords
- Multiple Sclerosis, relapsing, Rebif New Formulation, Interferon beta-1a
- Medical subject headings
- Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1a (Rebif)Drug
Also called Rebif New Formulation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and type of injection site reactions (ISRs)
Measured: Month 3, 6, 9 and 12
Secondary outcomes (6)
Number of missed injections of Rebif New Formulation since the previous visit
Measured: Month 3, 6, 9 and 12
Reasons for missed injections of Rebif New Formulation since the previous visit
Measured: Month 3, 6, 9 and 12
Changes in quality of life (MusiQoL)
Measured: Baseline visit and at Month 6 and 12
Number and type (telephone, face-to-face, written) of interactions with nurse support
Measured: Month 3, 6, 9 and 12
Relapse rate
Measured: Month 3, 6, 9 and 12.
Proportion of subjects with dose reductions to 22 mcg as a result of tolerability
Measured: Month 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono Australia Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Lynn Sartori, Study director, Merck Serono Australia Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101776
- Sponsor's protocol ID
- 701068-522
- Acronym
- ReNew
- Status last verified
- Aug 2014
- First submitted
- 8 Apr 2010
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01101776
- Acronym / sponsor ID
- ReNew / 701068-522
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, relapsing, Rebif New Formulation, Interferon beta-1a
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono Australia Pty Ltd
- Study start
- Jan 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Ambulatory patients with Multiple Sclerosis who:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon beta-1a (Rebif)Also: Rebif New FormulationInterferon 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. | Drug | – |
Primary outcome
Incidence and type of injection site reactions (ISRs)
Time frame: Month 3, 6, 9 and 12
6 secondary outcomes
Number of missed injections of Rebif New Formulation since the previous visit
Time frame: Month 3, 6, 9 and 12
Reasons for missed injections of Rebif New Formulation since the previous visit
Time frame: Month 3, 6, 9 and 12
Changes in quality of life (MusiQoL)
Time frame: Baseline visit and at Month 6 and 12
Number and type (telephone, face-to-face, written) of interactions with nurse support
Time frame: Month 3, 6, 9 and 12
Relapse rate
Time frame: Month 3, 6, 9 and 12.
Proportion of subjects with dose reductions to 22 mcg as a result of tolerability
Time frame: Month 3, 6, 9 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn Sartori study director
Merck Serono Australia Pty Ltd
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 16 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and type of injection site reactions (ISRs) (time frame: Month 3, 6, 9 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.