Multiple SclerosisNCT01195857
Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration
An observational study of Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany.
Trial summary
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Sep 2009
- 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: Patients with relapsing remitting multiple sclerosis who are currently receiving Rebif treatment and using the Rebiject II injection device who are under regular review by a Multiple Sclerosis nurse.
Who may be able to join
- Have relapsing remitting multiple sclerosis and currently receiving Rebif treatment and using the Rebiject II injection device
- Be under regular review by a MS nurse
- Be aged 18 or above
- Be willing and able to participate in the trial and to have provided written informed consent
Who cannot join
- Receiving disease modifying therapy other than Rebif
- Receiving Rebif but not using the Rebiject II injection device
- Do not self inject
- Are unable or unwilling to provide informed consent
About this study
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times per week by subcutaneous injection. The Rebiject II device is an autoinjector which allows patients easier administration of their Rebif injections.
Prior to treatment, patients receive training on the use of the device and its maintenance. Currently, all treatments for MS are injectable and require long term patient commitment. Rebiject has been developed to improve patient convenience and comfort but does require multiple steps to be carried out in order for the injection to be delivered correctly. Reports from our local call centre and nurse advisors suggest that inaccuracies of use with the Rebiject device are common. By raising awareness of the level of inaccuracy and determining which steps patients are most likely not to complete correctly, modified training programs or modifications to current subject training may be put into place to address these issues. It is also important to demonstrate the link between poor use of the medication device and increased relapse rates or increased injection site reactions.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Rebif, Interferon beta-1a
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who correctly use the Rebiject II injection device based on reaching all correct injection steps as assessed by a nurse
Measured: up to 6 month
Secondary outcomes (6)
Most common 3 steps for error with the Rebiject II injection device out of the ten step checklist
Measured: up to 6 month
Correlation with recent training within the last 6 months
Measured: up to 6 month
Correlation with disease control (relapse rate)
Measured: up to 6 month
Length of time on treatment
Measured: up to 6 month
Presence of injection site reactions
Measured: up to 6 month
Cognitive impairment
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 2009
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
- 100 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
- Investigators
- Dr Gillian L Shepherd, MD, MRCP, Study director, Merck Serono Limited, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195857
- Sponsor's protocol ID
- EMR701068-512
- Status last verified
- Feb 2014
- First submitted
- 31 Aug 2010
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Caroline D'Arcy, Laura Parkes, Gillian Shepherd British Journal of Neuroscience Nursing, Vol. 8, Iss. 1, 26 Feb 2012, pp 25 - 31
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
- Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration
- ClinicalTrials.gov ID
- NCT01195857
- Acronym / sponsor ID
- EMR701068-512
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Rebif, Interferon beta-1a
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono Limited, UK
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 Sep 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.
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times per week by subcutaneous injection. The Rebiject II device is an autoinjector which allows patients easier administration of their Rebif injections.
Prior to treatment, patients receive training on the use of the device and its maintenance. Currently, all treatments for MS are injectable and require long term patient commitment. Rebiject has been developed to improve patient convenience and comfort but does require multiple steps to be carried out in order for the injection to be delivered correctly. Reports from our local call centre and nurse advisors suggest that inaccuracies of use with the Rebiject device are common. By raising awareness of the level of inaccuracy and determining which steps patients are most likely not to complete correctly, modified training programs or modifications to current subject training may be put into place to address these issues. It is also important to demonstrate the link between poor use of the medication device and increased relapse rates or increased injection site reactions.
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
- Patients with relapsing remitting multiple sclerosis who are currently receiving Rebif treatment and using the Rebiject II injection device who are under regular review by a Multiple Sclerosis nurse.
Key inclusion criteria (4 listed)
- Have relapsing remitting multiple sclerosis and currently receiving Rebif treatment and using the Rebiject II injection device
- Be under regular review by a MS nurse
- Be aged 18 or above
- Be willing and able to participate in the trial and to have provided written informed consent
Key exclusion criteria (4 listed)
- Receiving disease modifying therapy other than Rebif
- Receiving Rebif but not using the Rebiject II injection device
- Do not self inject
- Are unable or unwilling to provide informed consent
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
Percentage of subjects who correctly use the Rebiject II injection device based on reaching all correct injection steps as assessed by a nurse
Time frame: up to 6 month
6 secondary outcomes
Most common 3 steps for error with the Rebiject II injection device out of the ten step checklist
Time frame: up to 6 month
Correlation with recent training within the last 6 months
Time frame: up to 6 month
Correlation with disease control (relapse rate)
Time frame: up to 6 month
Length of time on treatment
Time frame: up to 6 month
Presence of injection site reactions
Time frame: up to 6 month
Cognitive impairment
Time frame: up to 6 month
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.
- Results publicationCaroline D'Arcy, Laura Parkes, Gillian Shepherd British Journal of Neuroscience Nursing, Vol. 8, Iss. 1, 26 Feb 2012, pp 25 - 31
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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.
Dr Gillian L Shepherd, MD, MRCP study director
Merck Serono Limited, UK
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany.
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 4 inclusion and 4 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.
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?
Percentage of subjects who correctly use the Rebiject II injection device based on reaching all correct injection steps as assessed by a nurse (time frame: up to 6 month). 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 NCT01195857, 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 4 Feb 2014.