Trial Outcomes & Findings for Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™ (NCT NCT02254304)
NCT ID: NCT02254304
Last Updated: 2018-03-30
Results Overview
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.
COMPLETED
PHASE4
106 participants
Month 12
2018-03-30
Participant Flow
The study was conducted at 7 sites in Romania.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
17
|
|
Overall Study
COMPLETED
|
75
|
13
|
|
Overall Study
NOT COMPLETED
|
14
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Injection site pain and Injection fear
|
1
|
0
|
|
Overall Study
Personal causes
|
4
|
1
|
|
Overall Study
Personal decision
|
1
|
0
|
Baseline Characteristics
Effectiveness of Rebif® in Clinically Isolated Syndrome and Relapsing Multiple Sclerosis Using RebiSmart™
Baseline characteristics by cohort
| Measure |
Rebif In RMS Subjects
n=89 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.1 years
STANDARD_DEVIATION 10.71 • n=5 Participants
|
31.6 years
STANDARD_DEVIATION 9.63 • n=7 Participants
|
35.4 years
STANDARD_DEVIATION 10.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Number of Subjects Living in City or Rural Area
City
|
71 subjects
n=5 Participants
|
13 subjects
n=7 Participants
|
84 subjects
n=5 Participants
|
|
Number of Subjects Living in City or Rural Area
Rural
|
18 subjects
n=5 Participants
|
4 subjects
n=7 Participants
|
22 subjects
n=5 Participants
|
|
Geographical Allocation
North eastern
|
18 subjects
n=5 Participants
|
3 subjects
n=7 Participants
|
21 subjects
n=5 Participants
|
|
Geographical Allocation
North western
|
23 subjects
n=5 Participants
|
3 subjects
n=7 Participants
|
26 subjects
n=5 Participants
|
|
Geographical Allocation
South eastern
|
45 subjects
n=5 Participants
|
10 subjects
n=7 Participants
|
55 subjects
n=5 Participants
|
|
Geographical Allocation
South western
|
3 subjects
n=5 Participants
|
1 subjects
n=7 Participants
|
4 subjects
n=5 Participants
|
|
Nicotine Used Status
Never used
|
63 subjects
n=5 Participants
|
10 subjects
n=7 Participants
|
73 subjects
n=5 Participants
|
|
Nicotine Used Status
Regular user
|
19 subjects
n=5 Participants
|
3 subjects
n=7 Participants
|
22 subjects
n=5 Participants
|
|
Nicotine Used Status
Occasional user
|
0 subjects
n=5 Participants
|
0 subjects
n=7 Participants
|
0 subjects
n=5 Participants
|
|
Nicotine Used Status
Former user
|
7 subjects
n=5 Participants
|
4 subjects
n=7 Participants
|
11 subjects
n=5 Participants
|
|
Alcohol Consumption
Subjects consumed alcohol
|
3 subjects
n=5 Participants
|
1 subjects
n=7 Participants
|
4 subjects
n=5 Participants
|
|
Alcohol Consumption
Subjects did not consume alcohol
|
86 subjects
n=5 Participants
|
16 subjects
n=7 Participants
|
102 subjects
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=89 Participants
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.
|
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.
|
|---|---|---|
|
Percentage of Relapse-free RMS Subjects
|
66.3 percentage of subjects
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=17 Participants
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.
|
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.
|
|---|---|---|
|
Time to the First Relapse for CIS Subjects
|
NA months
Median Kaplan Meier time to first relapse and inter-quartile range was not reached in the study because relapse was reported in only 1 subject.
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=89 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Percentage of Subjects With Treatment Adherence
Adherence <=50%
|
2.2 percentage of subjects
|
11.8 percentage of subjects
|
|
Percentage of Subjects With Treatment Adherence
Adherence >75-90%
|
13.5 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Treatment Adherence
Adherence >90%
|
80.9 percentage of subjects
|
88.2 percentage of subjects
|
|
Percentage of Subjects With Treatment Adherence
Missing
|
1.1 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Treatment Adherence
Adherence >50-75%
|
2.2 percentage of subjects
|
0.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=89 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status Missing, Adherence >50-75%
|
50.0 percentage of subjects
|
—
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status Missing, Adherence >75-90%
|
33.3 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status Yes, Adherence <= 50%
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status Yes, Adherence >50-75%
|
0.0 percentage of subjects
|
—
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status Yes, Adherence >75-90%
|
16.7 percentage of subjects
|
—
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status Yes, Adherence >90%
|
19.4 percentage of subjects
|
6.7 percentage of subjects
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status Yes, Adherence Missing
|
0.0 percentage of subjects
|
—
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status No, Adherence <= 50%
|
0.0 percentage of subjects
|
50.0 percentage of subjects
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status No, Adherence >50-75%
|
50.0 percentage of subjects
|
—
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status No, Adherence >75-90%
|
50.0 percentage of subjects
|
—
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status No, Adherence >90%
|
72.2 percentage of subjects
|
73.3 percentage of subjects
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status No, Adherence Missing
|
0.0 percentage of subjects
|
—
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status Missing, Adherence <=50%
|
100.0 percentage of subjects
|
50.0 percentage of subjects
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status Missing, Adherence >90%
|
8.3 percentage of subjects
|
20.0 percentage of subjects
|
|
Percentage of Subjects With Relapse by Adherence Category
Relapse Status Missing, Adherence Missing
|
100.0 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
Percentage of subjects who prematurely terminated treatment and reasons were presented.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=89 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Percentage of Subjects Who Prematurely Terminated Treatment and Reasons
Adverse Event
|
2.2 percentage of subjects
|
5.9 percentage of subjects
|
|
Percentage of Subjects Who Prematurely Terminated Treatment and Reasons
Lost to follow-up
|
2.2 percentage of subjects
|
11.8 percentage of subjects
|
|
Percentage of Subjects Who Prematurely Terminated Treatment and Reasons
Protocol Non-compliance
|
1.1 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Who Prematurely Terminated Treatment and Reasons
Withdrew Consent
|
3.4 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Who Prematurely Terminated Treatment and Reasons
Pain at Injection site and fear of Injection
|
1.1 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Who Prematurely Terminated Treatment and Reasons
Personal causes
|
4.5 percentage of subjects
|
5.9 percentage of subjects
|
|
Percentage of Subjects Who Prematurely Terminated Treatment and Reasons
Personal decision
|
1.1 percentage of subjects
|
0.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: 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.
Expanded Disability Status Scale is abbreviated as EDSS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: 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.
Expanded Disability Status Scale is abbreviated as EDSS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=89 Participants
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.
|
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.
|
|---|---|---|
|
Mean Number of Relapses in RMS Subjects
|
0.2 relapses
Standard Deviation 0.54
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=62 Participants
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.
|
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.
|
|---|---|---|
|
Number of Subjects With Reasons of Missed Injections
Device malfunctions
|
1 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Device not functioning
|
1 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Difficulty using the device
|
1 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Elevated ALT and AST
|
1 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
could not came at the scheduled visit
|
1 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Patient redrawn intracutaneous
|
1 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Forgot to Injection
|
48 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Tired
|
23 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Fear of Injection
|
11 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Did not want to have Injection
|
5 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Pain at Injection site
|
5 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Flu-like symptoms
|
4 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Adverse event
|
2 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Device broken
|
1 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Elevated liver enzymes
|
2 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Increased GOT and GPT levels
|
2 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Local erythema and induration
|
1 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Missed study medication
|
1 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Forgot the device at home
|
1 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
No access to medication
|
1 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Stop the treatment
|
1 subjects
|
—
|
|
Number of Subjects With Reasons of Missed Injections
Technical problems with Rebismart
|
1 subjects
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
Evaluation of RebiSmart was categorized under very easy, quite easy, Neither easy nor difficult, very difficult and missing
Outcome measures
| Measure |
Rebif In RMS Subjects
n=89 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Overall Evaluation of RebiSmart Use as Assessed by Investigator
Very easy
|
46 subjects
|
13 subjects
|
|
Overall Evaluation of RebiSmart Use as Assessed by Investigator
Quite easy
|
32 subjects
|
1 subjects
|
|
Overall Evaluation of RebiSmart Use as Assessed by Investigator
Neither easy nor difficult
|
9 subjects
|
1 subjects
|
|
Overall Evaluation of RebiSmart Use as Assessed by Investigator
Quite difficult
|
0 subjects
|
0 subjects
|
|
Overall Evaluation of RebiSmart Use as Assessed by Investigator
Very difficult
|
1 subjects
|
2 subjects
|
|
Overall Evaluation of RebiSmart Use as Assessed by Investigator
Missing
|
1 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=88 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS)
|
0.2 visits
Standard Deviation 0.49
|
0.1 visits
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=16 Participants
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.
|
Rebif in CIS Subjects
n=1 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit
Specialist
|
15 subjects
|
0 subjects
|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit
General practitioner
|
1 subjects
0.49
|
1 subjects
0.49
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=88 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home
|
0.0 visits
Standard Deviation 0.11
|
0.0 visits
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=88 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS)
|
0.0 emergency room visits
Standard Deviation 0.00
|
0.0 emergency room visits
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=88 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS)
|
0.1 days
Standard Deviation 0.75
|
0.0 days
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=88 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS)
|
2 subjects
0.75
|
1 subjects
0.00
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=2 Participants
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.
|
Rebif in CIS Subjects
n=1 Participants
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.
|
|---|---|---|
|
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
|
2.0 days per week
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed.
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=2 Participants
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.
|
Rebif in CIS Subjects
n=1 Participants
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.
|
|---|---|---|
|
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
|
4.0 hours per day
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed.
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=88 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS)
|
1 subject
1.41
|
1 subject
NA
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=1 Participants
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.
|
Rebif in CIS Subjects
n=1 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS)
|
1 days
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed.
|
3 days
Standard Deviation NA
Standard deviation could not be estimated as there was only 1 subject analyzed.
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=88 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS).
|
2 subjects
1.41
|
2 subjects
NA
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=2 Participants
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.
|
Rebif in CIS Subjects
n=2 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects
|
46.5 days
Standard Deviation 61.52
|
3.5 days
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=88 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS).
|
1 subjects
1.41
|
2 subjects
NA
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=1 Participants
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.
|
Rebif in CIS Subjects
n=2 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects
|
8.0 hours per day
Standard Deviation NA
Standard deviation could not be estimated as there was only one subject analyzed.
|
3.0 hours per day
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=88 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS)
|
7 subjects
NA
|
1 subjects
2.83
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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%)
Outcome measures
| Measure |
Rebif In RMS Subjects
n=7 Participants
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.
|
Rebif in CIS Subjects
n=1 Participants
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.
|
|---|---|---|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
0% Work Completed
|
0 Subjects
NA
|
0 Subjects
2.83
|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
70% Work Completed
|
0 Subjects
|
0 Subjects
|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
90% Work Completed
|
2 Subjects
|
0 Subjects
|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
100% Work Completed
|
0 Subjects
|
0 Subjects
|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
10% Work Completed
|
1 Subjects
|
0 Subjects
|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
20% Work Completed
|
0 Subjects
|
0 Subjects
|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
30% Work Completed
|
1 Subjects
|
0 Subjects
|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
40% Work Completed
|
0 Subjects
|
0 Subjects
|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
50% Work Completed
|
0 Subjects
|
0 Subjects
|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
60% Work Completed
|
0 Subjects
|
0 Subjects
|
|
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)
80% Work Completed
|
3 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: Month 12Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=89 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score
Low Adherence
|
23 subjects
|
3 subjects
|
|
Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score
Medium Adherence
|
45 subjects
|
6 subjects
|
|
Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score
High Adherence
|
21 subjects
|
8 subjects
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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.
Outcome measures
| Measure |
Rebif In RMS Subjects
n=106 Participants
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.
|
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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).
Outcome measures
| Measure |
Rebif In RMS Subjects
n=89 Participants
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.
|
Rebif in CIS Subjects
n=17 Participants
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.
|
|---|---|---|
|
Expanded Disability Status Scale (EDSS) Score
Baseline
|
1.87 Units on a scale
Standard Deviation 0.991
|
1.24 Units on a scale
Standard Deviation 0.615
|
|
Expanded Disability Status Scale (EDSS) Score
Month 12
|
1.80 Units on a scale
Standard Deviation 0.981
|
1.13 Units on a scale
Standard Deviation 0.581
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
BMI was defined as weight in kilogram (kg) divided by height in square meter (m\^2).
Outcome measures
| Measure |
Rebif In RMS Subjects
n=106 Participants
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.
|
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.
|
|---|---|---|
|
Body Mass Index (BMI)
Baseline
|
23.57 Kg/m^2
Standard Deviation 3.347
|
—
|
|
Body Mass Index (BMI)
Month 12
|
23.51 Kg/m^2
Standard Deviation 3.582
|
—
|
Adverse Events
Rebif
Serious adverse events
| Measure |
Rebif
n=106 participants at risk
Rebif was administered in RMS and CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
|
|---|---|
|
Psychiatric disorders
Depression
|
0.94%
1/106 • Baseline up to 12 months
AE/ADR was planned to be collected for both the arms together.
|
Other adverse events
| Measure |
Rebif
n=106 participants at risk
Rebif was administered in RMS and CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
|
|---|---|
|
General disorders
Influenza Like Illness
|
8.5%
9/106 • Baseline up to 12 months
AE/ADR was planned to be collected for both the arms together.
|
|
Investigations
Hepatic Enzyme Increased
|
6.6%
7/106 • Baseline up to 12 months
AE/ADR was planned to be collected for both the arms together.
|
Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER