Multiple Sclerosis, Relapsing-RemittingSMARTNCT01108887
An Observational Study for the Assessment of Adherence, Effectiveness and Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™.
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Merck KGaA, Darmstadt, Germany at 1 site in Netherlands.
Trial summary
RebiSmart™ is a device with an electronic injection log to monitoring adherence to therapy. Therefore RebiSmart is a tool for administering Rebif in multi-dose cartridges that may improve patient satisfaction and adherence to therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- How many people
- 912 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2009to Jan 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with RMS naïve to treatment or currently being treated with Rebif multi-dose injected by RebiSmart for no more than 6 weeks
Who may be able to join
- Males and female subjects between 18-65 years of age (only in Germany: Males and females between 12 - 65 years of age in order to follow national medical society guidelines)
- Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined by either: a) Post-menopausal or surgically sterile, or b) Using a highly effective method of contraception for the duration of the study. This is defined as a method that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD), sexual abstinence or vasectomised partner
- Subjects diagnosed with Relapsing MS according to the revised McDonald Criteria (2005)
- MS-treatment naïve subjects or subjects treated with Rebif multi-dose injected by RebiSmart for no longer than 6 weeks prior to Baseline visit
- Subjects that are able to self-inject with RebiSmart (in the opinion of the physician)
- Subjects with Expanded Disability Status Scale (EDSS) score < 6 (inclusive) at Baseline
- Signed informed consent (in countries where subject signature is not mandatory: subject must be given the patient information)
Who cannot join
- Subjects experiencing a relapse within 30 days before Baseline
- Subjects who have participated in other studies within 30 days before Baseline
- Subjects who received any MS therapy within 6 months prior to study enrolment (e.g., other disease modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of Rebif multi-dose injected by RebiSmart
- Any visual or physical impairment that precludes the subject from self-injecting the treatment using the RebiSmart
- Pregnancy and breast-feeding
- Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
- Current or past (within the last 2 years) history of alcohol or drug abuse
- Have any contra-indications to treatment with interferon beta-1a according to Summary of Product Characteristics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Adherence, Effectiveness & Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™.
RebiSmart™ is a device with an electronic injection log to monitoring adherence to therapy. Therefore RebiSmart is a tool for administering Rebif in multi-dose cartridges that may improve patient satisfaction and adherence to therapy. The objectives of this study are to evaluate adherence, effectiveness and convenience of treatment in subjects with relapsing multiple sclerosis (RMS) using RebiSmart to self-inject Rebif in a multi-dose cartridge.
Read the detailed description
This is an observational, international, multicenter study planned to be conducted in RMS subjects using the RebiSmart auto-injector at 300 sites in 15 countries across Europe. The participating countries are Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Lithuania, Portugal, Slovakia, Sweden, Switzerland, the Netherlands and the United Kingdom. Subjects with RMS naïve to treatment or currently being treated with Rebif multi-dose injected by RebiSmart for no more than 6 weeks and meeting the eligibility criteria will receive Rebif 22 or 44 mcg subcutaneously three time a week. The dose of Rebif will be titrated during the initial four weeks of treatment. The planned observational period per subject is 12 months. The study visits comprises of: Baseline or Day 1 (Visit 1), Month 6 (Visit 2), and Month 12 (Visit 3).
OBJECTIVES
Primary objective:
- To assess adherence to treatment in subjects with RMS using RebiSmart to self-inject Rebif in a multi-dose cartridge
Secondary objectives:
- To assess effectiveness and convenience of treatment in subjects with RMS using RebiSmart to self-inject Rebif in a multi-dose cartridge.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, RebiSmart, Rebif, Interferon beta-1a
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to treatment
Proportion of expected number of injections completed during 12 months of treatment as captured by RebiSmart.
Measured: Baseline to 12 months of treatment
Secondary outcomes (2)
Effectiveness and convenience of treatment
Overall evaluation of RebiSmart use based on Convenience Questionnaire; reasons for missed injections; proportion of subjects who prematurely terminated treatment and reasons why, proportion of subjects remaining disease-free, proportion of subjects relapse free; mean number of relapses
Measured: Baseline to 12 months of treatment
Safety of treatment
Recording of adverse reactions
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionJan 2013
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 Sclerosis, Relapsing-RemittingStudies 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
- 912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono S.A., Geneva
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Serono, a division of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108887
- Sponsor's protocol ID
- EMR 701068-526
- Acronym
- SMART
- Status last verified
- Sep 2013
- First submitted
- 21 Apr 2010
- Last updated
- 17 Sep 2013
- Results posted
- No
Publications
Bayas A, Ouallet JC, Kallmann B, Hupperts R, Fulda U, Marhardt K; SMART study group. Adherence to, and effectiveness of, subcutaneous interferon beta-1a administered by RebiSmart(R) in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study. Expert Opin Drug Deliv. 2015 Aug;12(8):1239-50. doi: 10.1517/17425247.2015.1057567. Epub 2015 Jun 22.
PubMed 26098143
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Adherence, Effectiveness & Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™.
- ClinicalTrials.gov ID
- NCT01108887
- Acronym / sponsor ID
- SMART / EMR 701068-526
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, RebiSmart, Rebif, Interferon beta-1a
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 912 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono S.A., Geneva
- Study start
- Sep 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 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.
RebiSmart™ is a device with an electronic injection log to monitoring adherence to therapy. Therefore RebiSmart is a tool for administering Rebif in multi-dose cartridges that may improve patient satisfaction and adherence to therapy. The objectives of this study are to evaluate adherence, effectiveness and convenience of treatment in subjects with relapsing multiple sclerosis (RMS) using RebiSmart to self-inject Rebif in a multi-dose cartridge.
Detailed description
This is an observational, international, multicenter study planned to be conducted in RMS subjects using the RebiSmart auto-injector at 300 sites in 15 countries across Europe. The participating countries are Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Lithuania, Portugal, Slovakia, Sweden, Switzerland, the Netherlands and the United Kingdom. Subjects with RMS naïve to treatment or currently being treated with Rebif multi-dose injected by RebiSmart for no more than 6 weeks and meeting the eligibility criteria will receive Rebif 22 or 44 mcg subcutaneously three time a week. The dose of Rebif will be titrated during the initial four weeks of treatment. The planned observational period per subject is 12 months. The study visits comprises of: Baseline or Day 1 (Visit 1), Month 6 (Visit 2), and Month 12 (Visit 3).
OBJECTIVES
Primary objective:
- To assess adherence to treatment in subjects with RMS using RebiSmart to self-inject Rebif in a multi-dose cartridge
Secondary objectives:
- To assess effectiveness and convenience of treatment in subjects with RMS using RebiSmart to self-inject Rebif in a multi-dose cartridge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with RMS naïve to treatment or currently being treated with Rebif multi-dose injected by RebiSmart for no more than 6 weeks
Key inclusion criteria (7 listed)
- Males and female subjects between 18-65 years of age (only in Germany: Males and females between 12 - 65 years of age in order to follow national medical society guidelines)
- Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined by either: a) Post-menopausal or surgically sterile, or b) Using a highly effective method of contraception for the duration of the study. This is defined as a method that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD), sexual abstinence or vasectomised partner
- Subjects diagnosed with Relapsing MS according to the revised McDonald Criteria (2005)
- MS-treatment naïve subjects or subjects treated with Rebif multi-dose injected by RebiSmart for no longer than 6 weeks prior to Baseline visit
- Subjects that are able to self-inject with RebiSmart (in the opinion of the physician)
Key exclusion criteria (8 listed)
- Subjects experiencing a relapse within 30 days before Baseline
- Subjects who have participated in other studies within 30 days before Baseline
- Subjects who received any MS therapy within 6 months prior to study enrolment (e.g., other disease modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of Rebif multi-dose injected by RebiSmart
- Any visual or physical impairment that precludes the subject from self-injecting the treatment using the RebiSmart
- Pregnancy and breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to treatment
Time frame: Baseline to 12 months of treatment
Proportion of expected number of injections completed during 12 months of treatment as captured by RebiSmart.
2 secondary outcomes
Effectiveness and convenience of treatment
Time frame: Baseline to 12 months of treatment
Safety of treatment
Time frame: Baseline to 12 months
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 17 Sep 2013.
- Derived from this study: PubMed 26098143Bayas A, Ouallet JC, Kallmann B, Hupperts R, Fulda U, Marhardt K; SMART study group. Adherence to, and effectiveness of, subcutaneous interferon beta-1a administered by RebiSmart(R) in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study. Expert Opin Drug Deliv. 2015 Aug;12(8):1239-50. doi: 10.1517/17425247.2015.1057567. Epub 2015 Jun 22.
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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
Merck Serono, a division of Merck KGaA, Darmstadt, Germany
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, Relapsing-Remitting, run by Merck KGaA, Darmstadt, Germany at 1 site in Netherlands.
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 17 Sep 2013. 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 Netherlands. 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?
Adherence to treatment (time frame: Baseline to 12 months of treatment). 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 NCT01108887, 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 17 Sep 2013.