Relapsing Multiple Sclerosis, Clinically Isolated Syndrome
Conditions
Keywords
Relapsing multiple sclerosis, Clinically isolated syndrome, RMS, CIS, RebiSmart™, Rebif®, Interferon beta-1a
Brief 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).
Interventions
DRUGRebif
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.
Sponsors
Merck Romania SRL, an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Relapse-free RMS Subjects | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Baseline up to 12 months | Percentage of subjects who prematurely terminated treatment and reasons were presented. |
| Percentage of Subjects Free From Clinical Disease Activity | Baseline up to 12 months | Expanded Disability Status Scale is abbreviated as EDSS. |
| Percentage of Subjects Free From Disability Progression | Baseline up to 12 months | Expanded Disability Status Scale is abbreviated as EDSS. |
| Mean Number of Relapses in RMS Subjects | 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. |
| Number of Subjects With Reasons of Missed Injections | Baseline up to 12 months | 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. |
| Overall Evaluation of RebiSmart Use as Assessed by Investigator | Month 12 | Evaluation of RebiSmart was categorized under very easy, quite easy, Neither easy nor difficult, very difficult and missing |
| Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS) | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS) | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS) | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS) | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS) | Month 12 | 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. |
| Percentage of Subjects With Treatment Adherence | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS) | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS) | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS). | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS). | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS) | Month 12 | 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. |
| Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | Month 12 | 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%) |
| Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score | Month 12 | 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. |
| 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 | Baseline up to 12 months | 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. |
| Expanded Disability Status Scale (EDSS) Score | Baseline, Month 12 | 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). |
| Body Mass Index (BMI) | Baseline, Month 12 | BMI was defined as weight in kilogram (kg) divided by height in square meter (m\^2). |
| Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS) | Month 12 | 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. |
| Percentage of Subjects With Relapse by Adherence Category | 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. 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. |
Countries
Germany
Participant flow
Recruitment details
The study was conducted at 7 sites in Romania.
Participants by arm
| Arm | Count |
|---|---|
| Rebif In RMS Subjects Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. | 89 |
| Rebif in CIS Subjects Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. | 17 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Injection site pain and Injection fear | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Personal causes | 4 | 1 |
| Overall Study | Personal decision | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Rebif In RMS Subjects | Rebif in CIS Subjects | Total |
|---|---|---|---|
| Age, Continuous | 36.1 years STANDARD_DEVIATION 10.71 | 31.6 years STANDARD_DEVIATION 9.63 | 35.4 years STANDARD_DEVIATION 10.64 |
| Alcohol Consumption Subjects consumed alcohol | 3 subjects | 1 subjects | 4 subjects |
| Alcohol Consumption Subjects did not consume alcohol | 86 subjects | 16 subjects | 102 subjects |
| Geographical Allocation North eastern | 18 subjects | 3 subjects | 21 subjects |
| Geographical Allocation North western | 23 subjects | 3 subjects | 26 subjects |
| Geographical Allocation South eastern | 45 subjects | 10 subjects | 55 subjects |
| Geographical Allocation South western | 3 subjects | 1 subjects | 4 subjects |
| Nicotine Used Status Former user | 7 subjects | 4 subjects | 11 subjects |
| Nicotine Used Status Never used | 63 subjects | 10 subjects | 73 subjects |
| Nicotine Used Status Occasional user | 0 subjects | 0 subjects | 0 subjects |
| Nicotine Used Status Regular user | 19 subjects | 3 subjects | 22 subjects |
| Number of Subjects Living in City or Rural Area City | 71 subjects | 13 subjects | 84 subjects |
| Number of Subjects Living in City or Rural Area Rural | 18 subjects | 4 subjects | 22 subjects |
| Sex: Female, Male Female | 58 Participants | 7 Participants | 65 Participants |
| Sex: Female, Male Male | 31 Participants | 10 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 106 |
| serious Total, serious adverse events | 1 / 106 |
Outcome results
Primary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rebif In RMS Subjects | Percentage of Relapse-free RMS Subjects | 66.3 percentage of subjects |
Primary
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.
Time frame: Baseline up to 12 months
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rebif In RMS Subjects | Time to the First Relapse for CIS Subjects | NA months |
Secondary
Body Mass Index (BMI)
BMI was defined as weight in kilogram (kg) divided by height in square meter (m\^2).
Time frame: Baseline, Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rebif In RMS Subjects | Body Mass Index (BMI) | Baseline | 23.57 Kg/m^2 | Standard Deviation 3.347 |
| Rebif In RMS Subjects | Body Mass Index (BMI) | Month 12 | 23.51 Kg/m^2 | Standard Deviation 3.582 |
Secondary
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).
Time frame: Baseline, Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rebif In RMS Subjects | Expanded Disability Status Scale (EDSS) Score | Baseline | 1.87 Units on a scale | Standard Deviation 0.991 |
| Rebif In RMS Subjects | Expanded Disability Status Scale (EDSS) Score | Month 12 | 1.80 Units on a scale | Standard Deviation 0.981 |
| Rebif in CIS Subjects | Expanded Disability Status Scale (EDSS) Score | Baseline | 1.24 Units on a scale | Standard Deviation 0.615 |
| Rebif in CIS Subjects | Expanded Disability Status Scale (EDSS) Score | Month 12 | 1.13 Units on a scale | Standard Deviation 0.581 |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS) | 2.5 days per week | Standard Deviation 2.12 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS) | 2.0 days per week | — |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS) | 0.1 days | Standard Deviation 0.75 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS) | 0.0 days | Standard Deviation 0 |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects | 46.5 days | Standard Deviation 61.52 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects | 3.5 days | Standard Deviation 2.12 |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS) | 2.0 hours per day | Standard Deviation 1.41 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS) | 4.0 hours per day | — |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects | 8.0 hours per day | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects | 3.0 hours per day | Standard Deviation 2.83 |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS) | 7 subjects | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS) | 1 subjects | 2.83 |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects who visited to doctors for MS.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit | General practitioner | 1 subjects | 0.49 |
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit | Specialist | 15 subjects | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit | General practitioner | 1 subjects | 0.49 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit | Specialist | 0 subjects | — |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS). | 2 subjects | 1.41 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS). | 2 subjects | — |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS). | 1 subjects | 1.41 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS). | 2 subjects | — |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS) | 2 subjects | 0.75 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS) | 1 subjects | 0 |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS) | 1 subject | 1.41 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS) | 1 subject | — |
Secondary
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%)
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 30% Work Completed | 1 Subjects | — |
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 60% Work Completed | 0 Subjects | — |
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 20% Work Completed | 0 Subjects | — |
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 70% Work Completed | 0 Subjects | — |
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 40% Work Completed | 0 Subjects | — |
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 80% Work Completed | 3 Subjects | — |
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 10% Work Completed | 1 Subjects | — |
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 90% Work Completed | 2 Subjects | — |
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 50% Work Completed | 0 Subjects | — |
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 100% Work Completed | 0 Subjects | — |
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 0% Work Completed | 0 Subjects | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 100% Work Completed | 0 Subjects | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 0% Work Completed | 0 Subjects | 2.83 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 10% Work Completed | 0 Subjects | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 20% Work Completed | 0 Subjects | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 30% Work Completed | 0 Subjects | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 40% Work Completed | 0 Subjects | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 50% Work Completed | 0 Subjects | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 60% Work Completed | 0 Subjects | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 70% Work Completed | 0 Subjects | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 80% Work Completed | 1 Subjects | — |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS) | 90% Work Completed | 0 Subjects | — |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS) | 0.0 emergency room visits | Standard Deviation 0 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS) | 0.0 emergency room visits | Standard Deviation 0 |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home | 0.0 visits | Standard Deviation 0.11 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home | 0.0 visits | Standard Deviation 0 |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects who visited clinic for MS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS) | 0.2 visits | Standard Deviation 0.49 |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS) | 0.1 visits | Standard Deviation 0.49 |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rebif In RMS Subjects | Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS) | 1 days |
| Rebif in CIS Subjects | Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS) | 3 days |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rebif In RMS Subjects | Mean Number of Relapses in RMS Subjects | 0.2 relapses | Standard Deviation 0.54 |
Secondary
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.
Time frame: Baseline up to 12 months
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rebif In RMS Subjects | 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 | AE/ADR | 30 subjects |
| Rebif In RMS Subjects | 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 | Serious AE/ADR | 1 subjects |
| Rebif In RMS Subjects | 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 | AE/ADR Leading to Death | 0 subjects |
| Rebif In RMS Subjects | 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 | AE/ADR Leading to Early Termination | 4 subjects |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rebif In RMS Subjects | Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score | Low Adherence | 23 subjects |
| Rebif In RMS Subjects | Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score | Medium Adherence | 45 subjects |
| Rebif In RMS Subjects | Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score | High Adherence | 21 subjects |
| Rebif in CIS Subjects | Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score | Low Adherence | 3 subjects |
| Rebif in CIS Subjects | Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score | Medium Adherence | 6 subjects |
| Rebif in CIS Subjects | Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score | High Adherence | 8 subjects |
Secondary
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.
Time frame: Baseline up to 12 months
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects who missed the injections are evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Forgot to Injection | 48 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Tired | 23 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Fear of Injection | 11 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Did not want to have Injection | 5 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Pain at Injection site | 5 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Flu-like symptoms | 4 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Adverse event | 2 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Device broken | 1 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Device malfunctions | 1 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Device not functioning | 1 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Difficulty using the device | 1 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Elevated ALT and AST | 1 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Elevated liver enzymes | 2 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Increased GOT and GPT levels | 2 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Local erythema and induration | 1 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Missed study medication | 1 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Forgot the device at home | 1 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | No access to medication | 1 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | could not came at the scheduled visit | 1 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Patient redrawn intracutaneous | 1 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Stop the treatment | 1 subjects |
| Rebif In RMS Subjects | Number of Subjects With Reasons of Missed Injections | Technical problems with Rebismart | 1 subjects |
Secondary
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
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rebif In RMS Subjects | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Very easy | 46 subjects |
| Rebif In RMS Subjects | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Quite easy | 32 subjects |
| Rebif In RMS Subjects | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Neither easy nor difficult | 9 subjects |
| Rebif In RMS Subjects | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Quite difficult | 0 subjects |
| Rebif In RMS Subjects | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Very difficult | 1 subjects |
| Rebif In RMS Subjects | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Missing | 1 subjects |
| Rebif in CIS Subjects | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Very difficult | 2 subjects |
| Rebif in CIS Subjects | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Very easy | 13 subjects |
| Rebif in CIS Subjects | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Quite difficult | 0 subjects |
| Rebif in CIS Subjects | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Quite easy | 1 subjects |
| Rebif in CIS Subjects | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Missing | 0 subjects |
| Rebif in CIS Subjects | Overall Evaluation of RebiSmart Use as Assessed by Investigator | Neither easy nor difficult | 1 subjects |
Secondary
Percentage of Subjects Free From Clinical Disease Activity
Expanded Disability Status Scale is abbreviated as EDSS.
Time frame: Baseline up to 12 months
Population: Data could not be analyzed for this outcome because this is a composite outcome dependent on subjects free from relapses and EDSS progression, where EDSS progression requires to be collected every 3/6 months and confirmed 3/6 months later. Since EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated.
Secondary
Percentage of Subjects Free From Disability Progression
Expanded Disability Status Scale is abbreviated as EDSS.
Time frame: Baseline up to 12 months
Population: Data could not be analyzed for this outcome because this EDSS progression requires EDSS to be collected every 3/6 months and confirmed 3/6 months later. Since EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated.
Secondary
Percentage of Subjects Who Prematurely Terminated Treatment and Reasons
Percentage of subjects who prematurely terminated treatment and reasons were presented.
Time frame: Baseline up to 12 months
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rebif In RMS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Protocol Non-compliance | 1.1 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Pain at Injection site and fear of Injection | 1.1 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Lost to follow-up | 2.2 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Personal causes | 4.5 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Withdrew Consent | 3.4 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Personal decision | 1.1 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Adverse Event | 2.2 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Personal decision | 0.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Adverse Event | 5.9 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Lost to follow-up | 11.8 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Protocol Non-compliance | 0.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Withdrew Consent | 0.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Pain at Injection site and fear of Injection | 0.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects Who Prematurely Terminated Treatment and Reasons | Personal causes | 5.9 percentage of subjects |
Secondary
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.
Time frame: Month 12
Population: Full analysis set was used. Here Number analyzed signifies those subjects who were evaluable for specified categories. There were no subjects analyzed for certain categories (that is, Number analyzed= 0) because no subjects were evaluable for that arm in the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Missing, Adherence Missing | 100.0 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status No, Adherence >90% | 72.2 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status No, Adherence Missing | 0.0 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Missing, Adherence <=50% | 100.0 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Missing, Adherence >50-75% | 50.0 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Missing, Adherence >75-90% | 33.3 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Missing, Adherence >90% | 8.3 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Yes, Adherence <= 50% | 0.0 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Yes, Adherence >50-75% | 0.0 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Yes, Adherence >75-90% | 16.7 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Yes, Adherence >90% | 19.4 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Yes, Adherence Missing | 0.0 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status No, Adherence <= 50% | 0.0 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status No, Adherence >50-75% | 50.0 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status No, Adherence >75-90% | 50.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Yes, Adherence <= 50% | 0.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status No, Adherence <= 50% | 50.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Missing, Adherence >75-90% | 0.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Missing, Adherence >90% | 20.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Yes, Adherence >90% | 6.7 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status Missing, Adherence <=50% | 50.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects With Relapse by Adherence Category | Relapse Status No, Adherence >90% | 73.3 percentage of subjects |
Secondary
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.
Time frame: Month 12
Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rebif In RMS Subjects | Percentage of Subjects With Treatment Adherence | Adherence >50-75% | 2.2 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Treatment Adherence | Adherence >90% | 80.9 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Treatment Adherence | Adherence >75-90% | 13.5 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Treatment Adherence | Missing | 1.1 percentage of subjects |
| Rebif In RMS Subjects | Percentage of Subjects With Treatment Adherence | Adherence <=50% | 2.2 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects With Treatment Adherence | Missing | 0.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects With Treatment Adherence | Adherence <=50% | 11.8 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects With Treatment Adherence | Adherence >50-75% | 0.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects With Treatment Adherence | Adherence >75-90% | 0.0 percentage of subjects |
| Rebif in CIS Subjects | Percentage of Subjects With Treatment Adherence | Adherence >90% | 88.2 percentage of subjects |