Relapsing Remitting Multiple Sclerosis (RRMS)SCANSMARTNCT01125475
A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects
An observational study of Relapsing Remitting Multiple Sclerosis (RRMS), run by Merck KGaA, Darmstadt, Germany at 1 site in Norway.
Trial summary
The primary objective is to determine adherence to Rebif® New Formulation administered by RebiSmart during 12 weeks of therapy in patients with RRMS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis (RRMS)
- What is being tested?
- RebiSmart
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2010to Mar 2012
- 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: Neurology Clinics at Danish and Norwegian hospitals (single treatment group)
Who may be able to join
- Males and females between 18 and 65 years of age
- Have relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald Criteria (2005)
- Having an expanded disability status scale (EDSS) of less than 6 at the screening visit or within 2 months prior to the screening visit
- Stable treatment (defined as treatment after titration period) with RebiSmart administered Rebif new formulation (RNF) 22/44 mcg subcutaneously thrice a week for a minimum of 4 weeks prior to inclusion
- Previously treated with disease modifying drugs (DMDs) for a minimum of 6 months prior to the screening visit
- Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined by either:
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- Post-menopausal or surgically sterile; or
- 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 vasectomized partner
- Have a scheduled visit 12 weeks after the inclusion visit
- Willing and able to comply with the protocol for the duration of the study
- Have given written informed consent
Who cannot join
- Have had a relapse within 30 days prior to the first visit
- Have any contra-indications to treatment with Interferon-beta 1a according to Summary of Product Characteristics
- Have any other significant disease that in the Investigator's opinion would exclude the subject from the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects: the ScanSmart Study
The primary objective is to determine adherence to Rebif® New Formulation administered by RebiSmart during 12 weeks of therapy in patients with RRMS.
- Being tested
- RebiSmart
- Keywords
- Relapsing Remitting Multiple Sclerosis, RebiSmart, Rebif, Adherence
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebiSmartDevice
Treatment with Rebif New Formulation using RebiSmart.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence assessment
Adherence to RNF administered by RebiSmart during 12 weeks of therapy in patients with RRMS
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple Sclerosis (RRMS)Studies 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono Norway, Smerud Medical Research International AS
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Serono Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125475
- Sponsor's protocol ID
- EMR 701068-521
- Acronym
- SCANSMART
- Status last verified
- Sep 2012
- First submitted
- 17 May 2010
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects: the ScanSmart Study
- ClinicalTrials.gov ID
- NCT01125475
- Acronym / sponsor ID
- SCANSMART / EMR 701068-521
- Keywords
- Relapsing Remitting Multiple Sclerosis, RebiSmart, Rebif, Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono Norway, Smerud Medical Research International AS
- Study start
- Aug 2010
- Primary completion
- Mar 2012 (actual)
- First posted
- 18 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.
The primary objective is to determine adherence to Rebif® New Formulation administered by RebiSmart during 12 weeks of therapy in patients with RRMS.
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
- Neurology Clinics at Danish and Norwegian hospitals (single treatment group)
Key inclusion criteria (11 listed)
- Males and females between 18 and 65 years of age
- Have relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald Criteria (2005)
- Having an expanded disability status scale (EDSS) of less than 6 at the screening visit or within 2 months prior to the screening visit
- Stable treatment (defined as treatment after titration period) with RebiSmart administered Rebif new formulation (RNF) 22/44 mcg subcutaneously thrice a week for a minimum of 4 weeks prior to inclusion
- Previously treated with disease modifying drugs (DMDs) for a minimum of 6 months prior to the screening visit
Key exclusion criteria (3 listed)
- Have had a relapse within 30 days prior to the first visit
- Have any contra-indications to treatment with Interferon-beta 1a according to Summary of Product Characteristics
- Have any other significant disease that in the Investigator's opinion would exclude the subject from the trial
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 |
|---|---|---|
| RebiSmartTreatment with Rebif New Formulation using RebiSmart. | Device | – |
Primary outcome
Adherence assessment
Time frame: 12 weeks
Adherence to RNF administered by RebiSmart during 12 weeks of therapy in patients with RRMS
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 16 Jul 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.
Medical Director study director
Merck Serono Norway
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 Relapsing Remitting Multiple Sclerosis (RRMS), run by Merck KGaA, Darmstadt, Germany at 1 site in Norway.
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 11 inclusion and 3 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 16 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 Norway. 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 assessment (time frame: 12 weeks). 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 16 Jul 2014.