Multiple SclerosisMEASURENCT01128075
Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects
An observational study of Multiple Sclerosis and MS, run by Merck KGaA, Darmstadt, Germany at 1 site in Canada.
Trial summary
This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects with relapsing multiple sclerosis (RMS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, MS
- What is being tested?
- RebiSmart™
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 198 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Apr 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community and Academic MS clinics
Who may be able to join
- Males and females between 18 and 65 years of age.
- Have RMS according to the revised McDonald Criteria.
- Subject is eligible for Rebif® therapy according to indications and clinical use in the Rebif® Product Monograph.
- Be willing and able to comply with the protocol requirements for the duration of the study.
- Have given written informed consent prior to entering the screening period.
- Must register with the Rebif® Multiple Support Program.
- Subjects previously on disease modifying drugs (DMDs) must be stable and not be experiencing any side effects related to the previous DMDs at the time of enrollment into the study, in the opinion of the investigator. Rebif® will be prescribed as per Product Monograph and a washout period will be left at the discretion of the investigator.
Who cannot join
- Have any disease other than MS that could better explain his/her signs and symptoms.
- Receive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. The administration of a single injection for treatment or prophylaxis of a condition unrelated to the subject's MS (e.g.,influenza or pneumococcus vaccination) will be acceptable.
- Are contraindicated for the use of Rebif® according to the Rebif® Product Monograph.
- Have a diagnosis of clinically isolated syndrome (CIS).
- Participation in any other investigational trial prior to 30 days of Study Day 1.
- Any visual or physical impairment that precludes the subject from self-injecting the treatment using RebiSmart™
- Have received previous treatment with Rebif within 5 years prior to screening.
- Subjects have any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol or to complete the study questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Two-arm Non-comparative, Observational, 96-week Phase IV Study to Evaluate Treatment Adherence When Using RebiSmart™ for Self-injection of Rebif® in Multi-dose Cartridges in Subjects With Relapsing Multiple Sclerosis (RMS)
This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects with relapsing multiple sclerosis (RMS).
Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks.
The main purpose of this study is to evaluate treatment adherence for subjects with RMS over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
- Conditions
- Multiple Sclerosis, MS
- Being tested
- RebiSmart™
- Keywords
- RebiSmart, Rebif, Adherence, Multidose, Relapsing Multiple Sclerosis, RMS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebiSmart™Device
Also called Rebif
Electronic self-injection device (RebiSmart™) to inject Rebif®
RebiSmart™Device
Also called Rebif
Electronic self-injection device (RebiSmart™) to inject Rebif®
| Study group | Role | What they receive |
|---|---|---|
| naïve subjects | Cohort of RMS patients who initiate disease modifying treatment with Rebif® Receives: Device: RebiSmart™ | |
| non-naïve subjects | Cohort of RMS patients who initiate treatment with Rebif® after having failed therapy with other disease modifying drugs on the basis of lack of efficacy, compliance, safety, tolerability or convenience, as per clinical judgment of study investigator Receives: Device: RebiSmart™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment adherence for RMS subjects over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
Measured: 24 weeks
Secondary outcomes (6)
Long-term adherence in subjects with RMS over 96 weeks of treatment using RebiSmart for self-injection of Rebif® in multi-dose cartridge.
Measured: 96 weeks
Treatment persistence by measuring treatment discontinuations
Measured: 96 weeks
Treatment compliance
Measuring the number of injections received relative to the time on study
Measured: 96 weeks
Comparison of subject treatment adherence between categories of cognitive function
Measured by the short version of Rao's Brief Repeatable Battery (BRB)
Measured: 96 weeks
Longitudinal changes in anxiety symptoms
Measured by the Hospital Anxiety and Depression Scale (HAD) and State-Trait Anxiety Inventory (STAI)
Measured: 96 weeks
Qualitative assessment of subjects' experience with RebiSmart
A standardized Patient Experience Questionnaire (PEQ) will be used for the assessment.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startAug 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EMD Inc., Canada
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono, a division of EMD Inc., Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128075
- Sponsor's protocol ID
- EMR701068-520
- Acronym
- MEASURE
- Status last verified
- Jul 2014
- First submitted
- 20 May 2010
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Devonshire VA, Feinstein A, Moriarty P. Adherence to interferon beta-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study. BMC Res Notes. 2016 Mar 8;9:148. doi: 10.1186/s13104-016-1948-z.
PubMed 26951043
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Two-arm Non-comparative, Observational, 96-week Phase IV Study to Evaluate Treatment Adherence When Using RebiSmart™ for Self-injection of Rebif® in Multi-dose Cartridges in Subjects With Relapsing Multiple Sclerosis (RMS)
- ClinicalTrials.gov ID
- NCT01128075
- Acronym / sponsor ID
- MEASURE / EMR701068-520
- Conditions
- Multiple Sclerosis, MS
- Keywords
- RebiSmart, Rebif, Adherence, Multidose, Relapsing Multiple Sclerosis, RMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- EMD Inc., Canada
- Study start
- Aug 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 May 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 is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects with relapsing multiple sclerosis (RMS).
Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks.
The main purpose of this study is to evaluate treatment adherence for subjects with RMS over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| naïve subjects | – | Device: RebiSmart™Cohort of RMS patients who initiate disease modifying treatment with Rebif® |
| non-naïve subjects | – | Device: RebiSmart™Cohort of RMS patients who initiate treatment with Rebif® after having failed therapy with other disease modifying drugs on the basis of lack of efficacy, compliance, safety, tolerability or convenience, as per clinical judgment of study investigator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community and Academic MS clinics
Key inclusion criteria (7 listed)
- Males and females between 18 and 65 years of age.
- Have RMS according to the revised McDonald Criteria.
- Subject is eligible for Rebif® therapy according to indications and clinical use in the Rebif® Product Monograph.
- Be willing and able to comply with the protocol requirements for the duration of the study.
- Have given written informed consent prior to entering the screening period.
Key exclusion criteria (8 listed)
- Have any disease other than MS that could better explain his/her signs and symptoms.
- Receive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. The administration of a single injection for treatment or prophylaxis of a condition unrelated to the subject's MS (e.g.,influenza or pneumococcus vaccination) will be acceptable.
- Are contraindicated for the use of Rebif® according to the Rebif® Product Monograph.
- Have a diagnosis of clinically isolated syndrome (CIS).
- Participation in any other investigational trial prior to 30 days of Study Day 1.
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 |
|---|---|---|
| RebiSmart™Also: RebifElectronic self-injection device (RebiSmart™) to inject Rebif® | Device | naïve subjects |
| RebiSmart™Also: RebifElectronic self-injection device (RebiSmart™) to inject Rebif® | Device | non-naïve subjects |
Primary outcome
Treatment adherence for RMS subjects over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
Time frame: 24 weeks
6 secondary outcomes
Long-term adherence in subjects with RMS over 96 weeks of treatment using RebiSmart for self-injection of Rebif® in multi-dose cartridge.
Time frame: 96 weeks
Treatment persistence by measuring treatment discontinuations
Time frame: 96 weeks
Treatment compliance
Time frame: 96 weeks
Comparison of subject treatment adherence between categories of cognitive function
Time frame: 96 weeks
Longitudinal changes in anxiety symptoms
Time frame: 96 weeks
Qualitative assessment of subjects' experience with RebiSmart
Time frame: 96 weeks
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 9 Jul 2014.
- Derived from this study: PubMed 26951043Devonshire VA, Feinstein A, Moriarty P. Adherence to interferon beta-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study. BMC Res Notes. 2016 Mar 8;9:148. doi: 10.1186/s13104-016-1948-z.
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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.
Medical Responsible study director
EMD Serono, a division of EMD Inc., Canada
1 site 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 and MS, run by Merck KGaA, Darmstadt, Germany at 1 site in Canada.
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 7 inclusion and 8 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 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Treatment adherence for RMS subjects over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01128075, which also lists 1 linked publication.
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 9 Jul 2014.