Relapsing Multiple SclerosisPhase 4PROCEEDNCT02254304
Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™
A Phase 4 study testing Rebif in people with Relapsing Multiple Sclerosis and Clinically Isolated Syndrome, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
Trial summary
This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Multiple Sclerosis, Clinically Isolated Syndrome
- What is being tested?
- Rebif
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteGermany
- Study dates
- 31 Dec 2014to 20 Aug 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Male and female subjects between 18 to 65 years of age
- Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined in the protocol
- Subjects diagnosed with CIS or RMS according to the revised McDonald criteria (2010)
- Treatment-naive 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 less than (<) 6 (inclusive) at Baseline
- Signed informed consent and subject data collection form
Who cannot join
- Subjects experiencing a relapse within 30 days before Baseline
- Participation in other studies within 30 days before Baseline
- Received any MS therapy within 6 months prior to study enrolment (for example, 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, as per investigator opinion
- 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: Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania Using Electronic Device RebiSmart™
This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).
- Being tested
- Rebif
- Keywords
- Relapsing multiple sclerosis, Clinically isolated syndrome, RMS, CIS, RebiSmart™, Rebif®, Interferon beta-1a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebifDrug
Also called Interferon beta-1a
Rebif will be administered at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Rebif in Relapsing Multiple Sclerosis (RMS) Subjects | Experimental | Not described Receives: Drug: Rebif |
| Rebif in Clinically Isolated Syndromes (CIS) Subjects | Experimental | Not described Receives: Drug: Rebif |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Relapse-free RMS Subjects
A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Relapse-free RMS subjects were those who did not had relapse during 12 month treatment period. Data was planned to be reported for "Rebif in RMS Subjects" arm.
Measured: Month 12
Time to the First Relapse for CIS Subjects
A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to MS, accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Time to the first relapse was defined as the duration from start of the treatment until first relapse. Data was planned to be reported for "Rebif in CIS Subjects" arm.
Measured: Baseline up to 12 months
Secondary outcomes (28)
Percentage of Subjects With Treatment Adherence
According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with treatment adherence under different categories (<=50%, >50-75%, >75-90%, >90%) were presented.
Measured: Month 12
Percentage of Subjects With Relapse by Adherence Category
A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with relapses by adherence categories (<=50%, >50-75%, >75-90%, >90%) were presented. Adherence missing are the subjects who withdrew before 12 months and who did not have any relapses before withdrawal.
Measured: Month 12
Percentage of Subjects Who Prematurely Terminated Treatment and Reasons
Percentage of subjects who prematurely terminated treatment and reasons were presented.
Measured: Baseline up to 12 months
Percentage of Subjects Free From Clinical Disease Activity
Expanded Disability Status Scale is abbreviated as EDSS.
Measured: Baseline up to 12 months
Percentage of Subjects Free From Disability Progression
Expanded Disability Status Scale is abbreviated as EDSS.
Measured: Baseline up to 12 months
Mean Number of Relapses in RMS Subjects
A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days.
Measured: Month 12
Number of Subjects With Reasons of Missed Injections
Number of subjects with the reasons of missed injections were presented. Aspartate transaminase and alanine transaminase are abbreviated as ALT and AST respectively. Glutamic oxaloacetic transaminase and glutamic pyruvic transaminase are abbreviated as GOT and GPT respectively.
Measured: Baseline up to 12 months
Overall Evaluation of RebiSmart Use as Assessed by Investigator
Evaluation of RebiSmart was categorized under very easy, quite easy, Neither easy nor difficult, very difficult and missing
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS)
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of visits to clinic by subjects due to MS were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Subjects who took consultations with specialists, general practitioners for MS were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of visits by healthcare professional to subjects' home were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS)
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of times subjects visited emergency room due to MS were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS)
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of days subjects hospitalized due to MS were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS)
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who paid someone to assist them due to MS were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS)
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of days per week assistant worked for subject due to MS were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS)
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of hours per week assistant worked for subject due to MS were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS)
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects whose relatives or friends missed work due to subjects' MS were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS)
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of working days missed by relative or friend due to subjects' MS were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS).
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who missed any full days from work due to MS were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of full days missed from work by subjects were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS).
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who missed any partial days from work due to MS were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of hours per day missed from work by subjects were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS)
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects accomplished less work due to MS were presented.
Measured: Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Amount of work done by subjects in spite of multiple sclerosis was presented under different percentages (0-100%)
Measured: Month 12
Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score
The Morisky Medication Adherence Scale (MMAS) is a valid and reliable instrument that consists of 8 items that measure medication adherence. The scores of the MMAS-8 range from 0 to 8. This self-report scale consists of 7 items answered with a yes or no and 1 item with a 5-point Likert scale. A score below 6 indicates low adherence, a score between 6 to < 8 indicates medium adherence and a score of 8 indicates high adherence.
Measured: Month 12
Number of Subjects With Adverse Event or Adverse Drug Reaction (AE/ADR), Serious AE/ADR, AE/ADR Leading to Death and AE/ADR Leading to Early Termination
An AE was any untoward medical occurrence in a subject or clinical investigation in a subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to drug treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AE/ADR was planned to be reported for both the arms together.
Measured: Baseline up to 12 months
Expanded Disability Status Scale (EDSS) Score
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).
Measured: Baseline, Month 12
Body Mass Index (BMI)
BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2).
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study start31 Dec 2014
- Primary completion20 Aug 2016
- Study completion20 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Romania SRL, an affiliate of Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254304
- Sponsor's protocol ID
- 200136-583
- Other IDs
- 2014-001290-14, 2014
- Acronym
- PROCEED
- Status last verified
- Mar 2018
- First submitted
- 29 Sep 2014
- Last updated
- 30 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania Using Electronic Device RebiSmart™
- ClinicalTrials.gov ID
- NCT02254304
- Acronym / sponsor ID
- PROCEED / 200136-583
- Keywords
- Relapsing multiple sclerosis, Clinically isolated syndrome, RMS, CIS, RebiSmart™, Rebif®, Interferon beta-1a
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Romania SRL, an affiliate of Merck KGaA, Darmstadt, Germany
- Study start
- 31 Dec 2014 (actual)
- Primary completion
- 20 Aug 2016 (actual)
- Study completion
- 20 Aug 2016 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Posted 30 Mar 2018
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 Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rebif in Relapsing Multiple Sclerosis (RMS) Subjects | Experimental | Drug: Rebif |
| Rebif in Clinically Isolated Syndromes (CIS) Subjects | Experimental | Drug: Rebif |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects between 18 to 65 years of age
- Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined in the protocol
- Subjects diagnosed with CIS or RMS according to the revised McDonald criteria (2010)
- Treatment-naive 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
- Participation in other studies within 30 days before Baseline
- Received any MS therapy within 6 months prior to study enrolment (for example, 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RebifAlso: Interferon beta-1aRebif will be administered at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. | Drug | Rebif in Clinically Isolated Syndromes (CIS) Subjects, Rebif in Relapsing Multiple Sclerosis (RMS) Subjects |
Primary outcome
Percentage of Relapse-free RMS Subjects
Time frame: Month 12
A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Relapse-free RMS subjects were those who did not had relapse during 12 month treatment period. Data was planned to be reported for "Rebif in RMS Subjects" arm.
Time to the First Relapse for CIS Subjects
Time frame: Baseline up to 12 months
A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to MS, accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Time to the first relapse was defined as the duration from start of the treatment until first relapse. Data was planned to be reported for "Rebif in CIS Subjects" arm.
28 secondary outcomes
Percentage of Subjects With Treatment Adherence
Time frame: Month 12
Percentage of Subjects With Relapse by Adherence Category
Time frame: Month 12
Percentage of Subjects Who Prematurely Terminated Treatment and Reasons
Time frame: Baseline up to 12 months
Percentage of Subjects Free From Clinical Disease Activity
Time frame: Baseline up to 12 months
Percentage of Subjects Free From Disability Progression
Time frame: Baseline up to 12 months
Mean Number of Relapses in RMS Subjects
Time frame: Month 12
Number of Subjects With Reasons of Missed Injections
Time frame: Baseline up to 12 months
Overall Evaluation of RebiSmart Use as Assessed by Investigator
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS)
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS)
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS)
Time frame: Month 12
Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS)
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS)
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS)
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS)
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS)
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS).
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS).
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS)
Time frame: Month 12
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
Time frame: Month 12
Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score
Time frame: Month 12
Number of Subjects With Adverse Event or Adverse Drug Reaction (AE/ADR), Serious AE/ADR, AE/ADR Leading to Death and AE/ADR Leading to Early Termination
Time frame: Baseline up to 12 months
Expanded Disability Status Scale (EDSS) Score
Time frame: Baseline, Month 12
Body Mass Index (BMI)
Time frame: Baseline, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A Phase 4 study testing Rebif in people with Relapsing Multiple Sclerosis and Clinically Isolated Syndrome, 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 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 30 Mar 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 RMS Subjects (time frame: Month 12). The study lists 2 primary outcomes in all. 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 30 Mar 2018.