Multiple Sclerosis, Relapsing-remittingADHERQOLNCT02394782
Observational Study of Rebismart®2.0 + MSdialog™ in Subjects With Remitting Multiple Sclerosis (ADHERQOL)
An observational study of Multiple Sclerosis, Relapsing-remitting, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
Trial summary
This is a 24-month, observational, prospective, multinational, multicenter study to determine the relationship between the relapse (percentage of relapse free subjects) and adherence in subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the RebiSmart®2.0 and MSdialog™. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-remitting
- What is being tested?
- RebiSmart®2.0 and MSdialog™
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Mar 2016
- 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: Participating sites will identify and recruit eligible subjects using appropriate recruitment strategies in accordance with any local approvals/regulations for observational studies e.g. via clinics, referrals, advertisements, patient databases etc.
Who may be able to join
- Diagnosed with RRMS according to McDonald criteria 2010
- Relapse free within 30 days before Baseline data collection
- Treatment with Rebif for 6 months or more prior to informed consent
- Already using RebiSmart®2.0 + MSdialog™ for patient reported outcome (PRO) assessments (at least once prior to informed consent)
- Females of childbearing potential must be willing to use appropriate contraception for the duration of the study
- EDSS score less than (<) 6
- Written informed consent obtained prior to any protocol-required data collection
Who cannot join
- Participation in other studies within 30 days before Baseline
- Female who is pregnant or breast feeding
- Significant psychiatric symptoms that, in the opinion of the Investigator, would impact subject ability to comply with treatment (as per standard clinical practice)
- Any contraindication for Interferon (IFN) beta-1a therapy as per Summary of Product Characteristics (SPC)
- Administration of any Multiple Sclerosis (MS) therapy, other than Rebif, within 6 months prior to informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Observational, International, Multi-center Study to Measure the Relationship Between Relapse and Adherence in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With Rebismart®2.0 + MSdialog™, Assessing Quality of Life (ADHERQOL)
This is a 24-month, observational, prospective, multinational, multicenter study to determine the relationship between the relapse (percentage of relapse free subjects) and adherence in subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the RebiSmart®2.0 and MSdialog™.
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Being tested
- RebiSmart®2.0, MSdialog™
- Keywords
- Multiple sclerosis, relapsing-remitting, Rebif, Interferon beta-1a, RebiSmart®2.0, MSdialog™
- 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.
RebiSmart®2.0Device
Rebif (interferon beta-1a) will be administered by RebiSmart®2.0 as specified in Summary of Product Characteristics.
MSdialog™Device
Rebif (interferon beta-1a) will be administered by MSdialog™ as specified in Summary of Product Characteristics.
| Study group | Role | What they receive |
|---|---|---|
| Relapsing-remitting Multiple Sclerosis | Not described Receives: Device: RebiSmart®2.0; Device: MSdialog™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Relapse-free Subjects
Relapse is defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement.
Measured: Up to 24 months
Secondary outcomes (2)
Annualized Relapse Rate
Annualized relapse rate is calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Measured: Months 12 and 24
Multiple Sclerosis International Quality of Life (MusiQoL) and Multiple Sclerosis Quality of Life Inventory (MSQLI) Subscale Scores for MSdialog™
Normalized scores are calculated in the range of 0 - 100; where 0 = the worst QoL status and 100 = the best QoL status (as self-assessed by the subject).
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionMar 2016
Why it stopped: lower than anticipated recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394782
- Sponsor's protocol ID
- EMR200136-591
- Acronym
- ADHERQOL
- Status last verified
- Apr 2016
- First submitted
- 16 Mar 2015
- Last updated
- 25 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, International, Multi-center Study to Measure the Relationship Between Relapse and Adherence in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With Rebismart®2.0 + MSdialog™, Assessing Quality of Life (ADHERQOL)
- ClinicalTrials.gov ID
- NCT02394782
- Acronym / sponsor ID
- ADHERQOL / EMR200136-591
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Keywords
- Multiple sclerosis, relapsing-remitting, Rebif, Interferon beta-1a, RebiSmart®2.0, MSdialog™
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lower than anticipated recruitment rate
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Mar 2015 (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 24-month, observational, prospective, multinational, multicenter study to determine the relationship between the relapse (percentage of relapse free subjects) and adherence in subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the RebiSmart®2.0 and MSdialog™.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsing-remitting Multiple Sclerosis | – | Device: RebiSmart®2.0, Device: MSdialog™ |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participating sites will identify and recruit eligible subjects using appropriate recruitment strategies in accordance with any local approvals/regulations for observational studies e.g. via clinics, referrals, advertisements, patient databases etc.
Key inclusion criteria (7 listed)
- Diagnosed with RRMS according to McDonald criteria 2010
- Relapse free within 30 days before Baseline data collection
- Treatment with Rebif for 6 months or more prior to informed consent
- Already using RebiSmart®2.0 + MSdialog™ for patient reported outcome (PRO) assessments (at least once prior to informed consent)
- Females of childbearing potential must be willing to use appropriate contraception for the duration of the study
Key exclusion criteria (5 listed)
- Participation in other studies within 30 days before Baseline
- Female who is pregnant or breast feeding
- Significant psychiatric symptoms that, in the opinion of the Investigator, would impact subject ability to comply with treatment (as per standard clinical practice)
- Any contraindication for Interferon (IFN) beta-1a therapy as per Summary of Product Characteristics (SPC)
- Administration of any Multiple Sclerosis (MS) therapy, other than Rebif, within 6 months prior to 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RebiSmart®2.0Rebif (interferon beta-1a) will be administered by RebiSmart®2.0 as specified in Summary of Product Characteristics. | Device | Relapsing-remitting Multiple Sclerosis |
| MSdialog™Rebif (interferon beta-1a) will be administered by MSdialog™ as specified in Summary of Product Characteristics. | Device | Relapsing-remitting Multiple Sclerosis |
Primary outcome
Percentage of Relapse-free Subjects
Time frame: Up to 24 months
Relapse is defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement.
2 secondary outcomes
Annualized Relapse Rate
Time frame: Months 12 and 24
Multiple Sclerosis International Quality of Life (MusiQoL) and Multiple Sclerosis Quality of Life Inventory (MSQLI) Subscale Scores for MSdialog™
Time frame: Up to 24 months
Results and safety
The study was stopped early (reason given: lower than anticipated recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
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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 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 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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 25 Apr 2016. 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 Germany. 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 was stopped early (reason given: lower than anticipated recruitment rate). Results are not available in the source record.
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 Relapse-free Subjects (time frame: Up to 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 25 Apr 2016.