Relapsing Multiple SclerosisREADERNCT01601080
An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device
An observational study of Relapsing Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 1 site in United Kingdom.
Trial summary
This is an observational, retrospective, UK \& Ireland audit measuring patient adherence to Rebif® injections with the RebiSmart™ injection device. Data will be collected from Multiple Sclerosis (MS) patients who have been prescribed Rebif® and have been using the RebiSmart™ device for injection for a minimum of 24… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Relapsing Multiple Sclerosis
- How many people
- 230 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Oct 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Relapsing Multiple Sclerosis who have been prescribed Rebif® (22mcg or 44mcg)
Who may be able to join
- Relapsing Multiple Sclerosis (Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis with relapses) according to the Association of British Neurologists criteria (30) in the UK and the revised 2005 McDonald criteria (31) in Ireland
- Prescribed Rebif® (22mcg or 44mcg) using the RebiSmart™ injection device
- Have been using RebiSmart™ for 24 months and be due a device replacement as part of their standard routine of care
- Registered with Bupa Home Healthcare (UK) or SENSE nurse (Ireland)
- Be willing to give consent for their adherence data to be captured in the audit
Who cannot join
- Patients who do not fulfill entirely the inclusion criteria as well as the following:
- Discontinued Rebif before 24 months of treatment
- Unable or unwilling to give consent for their adherence data to be captured in the audit
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Please contact the
Merck KGaA Communication Center For Recruiting Locations
About this study
Official title: REbiSmart™ Retrospective ADherencE Review (READER) An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device
This is an observational, retrospective, UK \& Ireland audit measuring patient adherence to Rebif® injections with the RebiSmart™ injection device. Data will be collected from Multiple Sclerosis (MS) patients who have been prescribed Rebif® and have been using the RebiSmart™ device for injection for a minimum of 24 months.
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- Adherence, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Adherence
Percentage "RebiSmart measured" patient adherence to Rebif® injections
Measured: 24 months
Secondary outcomes (12)
Patient Adherence
Percentage "RebiSmart measured" patient adherence to Rebif® injections
Measured: 1 month
Patient Adherence
Percentage "RebiSmart™ measured" patient adherence to Rebif® injections
Measured: 3 months
Patient Adherence
Percentage "RebiSmart™ measured" patient adherence to Rebif® injections
Measured: 6 months
Patient Adherence
Percentage "RebiSmart™ measured" patient adherence to Rebif® injections
Measured: 12 months
Difference in patient adherence over time
Difference in percentage patient adherence between the first 12 months and second 12 months of treatment period.
Measured: 12 months
Medication Possession Ratio
Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels
Measured: 12 months
Medication Possession Ratio
Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels
Measured: 24 months
Adherence of patient subgroups
"RebiSmart™ measured" percentage adherence within and between the following patient sub-groups:
- patients who are and are not registered to MySupport (Rebif Support Programme)
- patient age groups
- patient gender
- prior use of a DMT
Measured: 12 months
Adherence of patient subgroups
"RebiSmart™ measured" percentage adherence within and between the following patient sub-groups:
- patients who are and are not registered to MySupport (Rebif Support Programme)
- patient age groups
- patient gender
- prior use of a DMT
Measured: 24 months
Patient Adherence in the UK versus Ireland
Reporting of UK and Ireland actual adherence levels separately
Measured: 12 months
Patient Adherence in the UK versus Ireland
Reporting of UK and Ireland actual adherence levels separately
Measured: 24 months
Device Comfort Settings
Preferred final comfort settings (at last injection)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing 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
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono Limited, UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601080
- Sponsor's protocol ID
- EMR200077-516
- Acronym
- READER
- Status last verified
- Feb 2014
- First submitted
- 15 May 2012
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REbiSmart™ Retrospective ADherencE Review (READER) An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device
- ClinicalTrials.gov ID
- NCT01601080
- Acronym / sponsor ID
- READER / EMR200077-516
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- Adherence, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono Limited, UK
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- First posted
- 17 May 2012 (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 an observational, retrospective, UK \& Ireland audit measuring patient adherence to Rebif® injections with the RebiSmart™ injection device. Data will be collected from Multiple Sclerosis (MS) patients who have been prescribed Rebif® and have been using the RebiSmart™ device for injection for a minimum of 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Relapsing Multiple Sclerosis who have been prescribed Rebif® (22mcg or 44mcg)
Key inclusion criteria (5 listed)
- Relapsing Multiple Sclerosis (Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis with relapses) according to the Association of British Neurologists criteria (30) in the UK and the revised 2005 McDonald criteria (31) in Ireland
- Prescribed Rebif® (22mcg or 44mcg) using the RebiSmart™ injection device
- Have been using RebiSmart™ for 24 months and be due a device replacement as part of their standard routine of care
- Registered with Bupa Home Healthcare (UK) or SENSE nurse (Ireland)
- Be willing to give consent for their adherence data to be captured in the audit
Key exclusion criteria (3 listed)
- Discontinued Rebif before 24 months of treatment
- Unable or unwilling to give consent for their adherence data to be captured in the audit
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
Patient Adherence
Time frame: 24 months
Percentage "RebiSmart measured" patient adherence to Rebif® injections
12 secondary outcomes
Patient Adherence
Time frame: 1 month
Patient Adherence
Time frame: 3 months
Patient Adherence
Time frame: 6 months
Patient Adherence
Time frame: 12 months
Difference in patient adherence over time
Time frame: 12 months
Medication Possession Ratio
Time frame: 12 months
Medication Possession Ratio
Time frame: 24 months
Adherence of patient subgroups
Time frame: 12 months
Adherence of patient subgroups
Time frame: 24 months
Patient Adherence in the UK versus Ireland
Time frame: 12 months
Patient Adherence in the UK versus Ireland
Time frame: 24 months
Device Comfort Settings
Time frame: 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 4 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 1 site in United Kingdom.
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 5 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 4 Feb 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 United Kingdom. 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?
Patient Adherence (time frame: 24 months). 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 4 Feb 2014.