Trial Outcomes & Findings for A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device (NCT NCT01791244)
NCT ID: NCT01791244
Last Updated: 2017-08-24
Results Overview
Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject's functioning.
COMPLETED
PHASE4
93 participants
Baseline and Month 12
2017-08-24
Participant Flow
A total of 93 subjects were randomized in the study out of which 46 were randomized to MinSupport Plus (MSP) and 47 to Technical support.
Participant milestones
| Measure |
Subject Support Program (MinSupport Plus)
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
47
|
|
Overall Study
Intent to Treat (ITT)
|
38
|
39
|
|
Overall Study
COMPLETED
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
15
|
18
|
Reasons for withdrawal
| Measure |
Subject Support Program (MinSupport Plus)
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
7
|
|
Overall Study
Insufficient clinical response
|
10
|
10
|
|
Overall Study
Laboratory Abnormality
|
0
|
1
|
Baseline Characteristics
A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device
Baseline characteristics by cohort
| Measure |
Subject Support Program (MinSupport Plus)
n=38 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=39 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 18 to 72 years
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Age, Customized
Greater than (>) 72 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: The ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject's functioning.
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=38 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=39 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12
Baseline
|
35.19 units on a scale
Standard Deviation 24.38
|
30.48 units on a scale
Standard Deviation 20.94
|
|
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12
Change at Month 12
|
-2.44 units on a scale
Standard Deviation 19.38
|
-3.04 units on a scale
Standard Deviation 19.76
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject's functioning.
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=38 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=39 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6
Baseline
|
35.19 units on a scale
Standard Deviation 24.38
|
30.48 units on a scale
Standard Deviation 20.94
|
|
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6
Change at Month 6
|
-1.36 units on a scale
Standard Deviation 16.82
|
-1.59 units on a scale
Standard Deviation 13.26
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The total score of the MSIS-29 was comprised of all the 29 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Score was calculated using following formula: sum of score for 29 questions - 29/1.45. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject's functioning.
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=38 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=39 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12
Baseline
|
21.81 units on a scale
Standard Deviation 21.55
|
18.01 units on a scale
Standard Deviation 16.61
|
|
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12
Change at Month 6
|
0.56 units on a scale
Standard Deviation 9.35
|
0.14 units on a scale
Standard Deviation 11.19
|
|
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12
Change at Month 12
|
1.00 units on a scale
Standard Deviation 11.34
|
0.00 units on a scale
Standard Deviation 10.45
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Quality of life was assessed using the EQ5D-5L score, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels with corresponding numeric scores ranging from 1 (no problems) through 5 (extreme problems) in which 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. A unique EQ5D-5L health state was defined by combining the numeric level scores for each of the 5 dimensions and the total score ranges from 5 to 25. An increase in the EQ5D-5L total score indicates worsening.
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=38 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=39 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12
Baseline
|
8.84 units on a scale
Standard Deviation 3.37
|
8.03 units on a scale
Standard Deviation 2.30
|
|
Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12
Change at Month 6
|
0.18 units on a scale
Standard Deviation 2.17
|
0.10 units on a scale
Standard Deviation 1.76
|
|
Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12
Change at Month 12
|
0.05 units on a scale
Standard Deviation 2.51
|
-0.08 units on a scale
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
EQ-5D-5L VAS was used to record a subject's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=38 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=39 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Visual Analogue Scale (VAS) Scale at Month 6 and 12
Baseline
|
71.18 units on a scale
Standard Deviation 20.70
|
71.49 units on a scale
Standard Deviation 16.61
|
|
Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Visual Analogue Scale (VAS) Scale at Month 6 and 12
Change at Month 6
|
-0.71 units on a scale
Standard Deviation 11.36
|
-3.38 units on a scale
Standard Deviation 19.35
|
|
Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Visual Analogue Scale (VAS) Scale at Month 6 and 12
Change at Month 12
|
-0.84 units on a scale
Standard Deviation 16.07
|
-2.31 units on a scale
Standard Deviation 20.60
|
SECONDARY outcome
Timeframe: Month 6 and 12Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
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 \<10% missed injections (measured with the software RDS 2.0) during 6 and 12 months were reported.
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=38 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=39 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Percentage of Subjects With Treatment Adherence at Month 6 and 12
At Month 6
|
71.05 Percentage of Subjects
|
64.10 Percentage of Subjects
|
|
Percentage of Subjects With Treatment Adherence at Month 6 and 12
At Month 12
|
65.79 Percentage of Subjects
|
53.85 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue.
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=38 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=39 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12
Baseline
|
3.93 units on a scale
Standard Deviation 1.75
|
3.98 units on a scale
Standard Deviation 1.72
|
|
Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12
Change at Month 6
|
0.15 units on a scale
Standard Deviation 0.79
|
0.05 units on a scale
Standard Deviation 0.81
|
|
Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12
Change at Month 12
|
0.13 units on a scale
Standard Deviation 0.89
|
0.08 units on a scale
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.. Here, "Overall Number of subjects analyzed" signifies those subjects who were evaluable for this outcome Measure.
The Modified Fatigue Impact Scale is a list of 21 statements describing how fatigue may affect a person's functioning. Answers ranging from 0 (Never) to 4 (Almost always). A total score ranged from a possible 0 (no fatigue impact) to 84 (almost always impacted by fatigue). A lower total score indicates less fatigue-related impact while a higher total score indicates greater fatigue-related impact on a subject's functioning.
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=37 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=36 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Change From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12
Baseline
|
29.74 units on a scale
Standard Deviation 20.50
|
31.08 units on a scale
Standard Deviation 19.08
|
|
Change From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12
Change at Month 6
|
3.89 units on a scale
Standard Deviation 10.81
|
2.27 units on a scale
Standard Deviation 9.78
|
|
Change From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12
Change at Month 12
|
3.75 units on a scale
Standard Deviation 10.43
|
1.78 units on a scale
Standard Deviation 10.65
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome Measure.
The Modified Fatigue Impact Index assesses fatigue- severity, distress, or degree of interference. Modified Fatigue Impact Scale Index was expressed in terms of percentage and ranged from 0% (no fatigue) to 100% (almost always impacted by fatigue).
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=37 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=36 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Change From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12
Change at Month 12
|
4.47 Percentage of fatigue
Standard Deviation 12.42
|
2.12 Percentage of fatigue
Standard Deviation 12.68
|
|
Change From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12
Baseline
|
35.40 Percentage of fatigue
Standard Deviation 24.41
|
37.00 Percentage of fatigue
Standard Deviation 22.72
|
|
Change From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12
Change at Month 6
|
4.63 Percentage of fatigue
Standard Deviation 12.87
|
2.71 Percentage of fatigue
Standard Deviation 11.64
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Hospital Anxiety and Depression Scale (HADS) was used to measure depression and anxiety in patients. The scale was limited to 14 questions, a practical tool for identifying and quantifying the two most common forms psychological disturbances in medical subjects. 7 of the items relate to anxiety and 7 relate to depression. Each item on the questionnaire was scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression where higher score indicates more anxiety/depression.
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=38 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=39 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12
Baseline (Anxiety Score)
|
6.13 units on a scale
Standard Deviation 4.14
|
5.62 units on a scale
Standard Deviation 3.21
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12
Change at Month 6 (Anxiety Score)
|
-0.21 units on a scale
Standard Deviation 2.92
|
-0.56 units on a scale
Standard Deviation 2.78
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12
Change at Month 12 (Anxiety Score)
|
-0.42 units on a scale
Standard Deviation 3.48
|
-0.18 units on a scale
Standard Deviation 3.26
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12
Baseline (Depression Score)
|
4.26 units on a scale
Standard Deviation 3.49
|
3.72 units on a scale
Standard Deviation 2.77
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12
Change at Month 6 (Depression Score)
|
0.61 units on a scale
Standard Deviation 2.43
|
0.46 units on a scale
Standard Deviation 2.85
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12
Change at Month 12 (Depression Score)
|
0.42 units on a scale
Standard Deviation 3.61
|
0.74 units on a scale
Standard Deviation 3.14
|
SECONDARY outcome
Timeframe: Month 12Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, "Overall Number of subjects analyzed" signifies those subjects who were evaluable for this outcome Measure.
Working ability was assessed by measuring the number of subjects for the following categories: 1) Subjects with full sickness/disability pension, 2) Subjects who were employed or had their own business, 3) Subjects who were retired, 4) Subjects who were studying, 5) None of the above.
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=32 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=35 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Number of Subjects With Working Ability at Month 12
None of the above
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Working Ability at Month 12
Subjects with full sickness/disability pension
|
4 Subjects
|
5 Subjects
|
|
Number of Subjects With Working Ability at Month 12
Subjects who were employed or had own business
|
22 Subjects
|
25 Subjects
|
|
Number of Subjects With Working Ability at Month 12
Subject who were retired
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects With Working Ability at Month 12
Subject who were studying
|
3 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: The Safety Population included all subjects who were randomized and received at least 1 dose of trial treatment.
AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE 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. Treatment Emergent Adverse Events (TEAEs) include both Serious TEAEs and non-serious TEAEs.
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=46 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=47 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Percentage of Subjects With Adverse Events (AE) up to Month 12
|
45.7 Percentage of Subjects
|
61.7 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Month 6 and 12Population: ITT population was used. Here, "Overall Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome Measure and "n" signifies those subjects who were evaluable for specified time points, respectively.
Lifestyle Questionnaire was used to assess the quality of life for subjects based on following parameters: Stress, Alcohol, Cost, Physical Aspect, Sleep, Activity and Smoking. Subjects provided their responses on the basis of three color codes: Green, Orange and Red, where Green refers to - no problem; Orange refers to - some problem and red refers to - definite/debilitating problem.
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=32 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Alcohol: Orange; n= 30
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Alcohol: Red; n= 30
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Alcohol: Green; n= 32
|
6 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Alcohol: Red; n= 32
|
6 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Alcohol: Orange; n= 32
|
6 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Stress: Red; n= 30
|
3 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Stress: Green; n= 31
|
3 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Stress: Orange; n= 31
|
2 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Stress: Red; n= 31
|
2 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Alcohol: Green; n= 30
|
7 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Stress: Green; n= 30
|
2 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Stress: Orange; n= 30
|
3 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Cost: Green; n= 30
|
4 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Cost: Orange; n= 30
|
4 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Cost: Red; n= 30
|
4 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Cost: Green; n= 32
|
3 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Cost: Orange; n= 32
|
3 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Cost: Red; n= 32
|
3 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Physical: Green; n= 30
|
5 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Physical: Orange; n= 30
|
2 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Physical: Red; n= 30
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Physical: Green; n= 32
|
5 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Physical: Orange; n= 32
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Physical: Red; n= 32
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Activity: Green; n= 30
|
5 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Activity: Orange; n= 30
|
2 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Activity: Red; n= 30
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Activity: Green; n= 32
|
5 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Activity: Orange; n= 32
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Activity: Red; n= 32
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Sleep: Green; n= 30
|
3 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Sleep: Orange; n= 30
|
4 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Sleep: Red; n= 30
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Sleep: Green; n= 32
|
3 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Sleep: Orange; n= 32
|
2 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Sleep: Red; n= 32
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Smoking: Green; n= 31
|
5 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Smoking: Orange; n= 31
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 6: Smoking: Red; n= 31
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Smoking: Green; n= 32
|
5 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Smoking: Orange; n= 32
|
1 Subjects
|
—
|
|
Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Month 12: Smoking: Red; n= 32
|
1 Subjects
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, "Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.
The subject satisfaction questionnaire was defined as satisfaction with overall treatment and support from health care providers during the last 12 months. Subjects were asked to rate their satisfaction by choosing either "Very discontented, discontented, contented or Very contented".
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=30 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=33 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12
Very discontented
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12
Discontented
|
6 Subjects
|
5 Subjects
|
|
Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12
Contented
|
13 Subjects
|
11 Subjects
|
|
Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12
Very contented
|
10 Subjects
|
15 Subjects
|
SECONDARY outcome
Timeframe: Month 12Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, "Overall Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.
The subject satisfaction questionnaire was defined as satisfaction with overall treatment and support from health care providers during the last 12 months. Subjects were asked to rate their satisfaction by choosing either "Very unsatisfied, unsatisfied, satisfied or very satisfied".
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=18 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=13 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12
Very unsatisfied
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12
Unsatisfied
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12
Satisfied
|
10 Subjects
|
9 Subjects
|
|
Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12
Very satisfied
|
6 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: Month 12Population: ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, "n" signifies subjects who were evaluable for the specific goal in this outcome measure.
Subjects defined up to 4 personal lifestyle goals during the first study week. Subjects completed the following questions related to lifestyle goals achieved during this study: 1. Was the goal achieved? (Yes/No) 2. If yes, better than expected or achieved as expected? 3. If better than expected, a lot or a little better than expected? 4. If no, a little or a lot less than expected?
Outcome measures
| Measure |
Subject Support Program (MinSupport Plus)
n=38 Participants
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
Goal 1(G1) : Goal Achieved; n= 38
|
18 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G1: Goal not Achieved; n= 38
|
4 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G1: Missing; n= 38
|
16 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G1 Achieved: Better than Expected; n= 18
|
5 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G1 Achieved: As Expected; n= 18
|
10 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G1 Achieved: Missing; n= 18
|
3 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G1Acheived:Better than Expected:Little Better;n= 5
|
4 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G1Achieved:Better than expected:Lot better; n= 5
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G1Achieved:Better than Expected: Missing; n= 5
|
1 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G1 not Achieved: Little Less; n= 4
|
1 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G1 not Achieved: Lot Less; n= 4
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G1 not Achieved: Missing; n= 4
|
3 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
Goal 2 (G2): Goal Achieved; n= 38
|
3 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G2: Goal not Achieved; n= 38
|
1 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G2: Missing; n= 38
|
34 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G2 Achieved: Better than Expected; n= 3
|
2 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G2 Achieved: As Expected; n= 3
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G2 Achieved: Missing; n= 3
|
1 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G2Achieved:Better than Expected:Little Better;n= 2
|
1 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G2 Achieved: Better than Expected:Lot Better; n= 2
|
1 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G2 Achieved: Better than Expected: Missing; n= 2
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G2 not Achieved: Little Less; n= 1
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G2 not Achieved: Lot Less; n= 1
|
1 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G2 not Achieved: Missing; n= 1
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
Goal 3 (G3): Goal Achieved; n= 38
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G3: Goal not Achieved; n= 38
|
1 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G3: Missing; n= 38
|
37 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G3 Achieved: As Expected; n= 0
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G3 Achieved: Better than Expected; n= 0
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G3 Achieved: Missing; n= 0
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G3 Achieved:Better than Expected:Little Better;n=0
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G3 Achieved:Better than Expected: Lot Better;n=0
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G3 Achieved: Better than Expected: Missing; n= 0
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G3 not Achieved: Little Less; n= 1
|
1 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G3 not Achieved: Lot Less; n= 1
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G3 not Achieved: Missing; n= 1
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
Goal 4 (G4): Goal Achieved; n= 38
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G4: Goal not Achieved; n= 38
|
1 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G4: Missing; n= 38
|
37 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G4 Achieved: Better than Expected; n= 0
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G4 Achieved: As Expected; n= 0
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G4 Achieved: Missing; n= 0
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G4 Expected:Little Better; n= 0
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G4Achieved:Better than expected:Lot Better; n= 0
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G4 Achieved: Better than Expected: Missing; n= 0
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G4 not Achieved: Little Less; n= 1
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G4 not Achieved: Lot Less; n= 1
|
0 Subjects
|
—
|
|
Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
G4 not Achieved: Missing; n= 1
|
1 Subjects
|
—
|
Adverse Events
Patient Support Program (MinSupport Plus)
Technical Support for the RebiSmart™ Device
Serious adverse events
| Measure |
Patient Support Program (MinSupport Plus)
n=46 participants at risk
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=47 participants at risk
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Infections and infestations
Urinary tract infection
|
4.3%
2/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
Other adverse events
| Measure |
Patient Support Program (MinSupport Plus)
n=46 participants at risk
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
|
Technical Support for the RebiSmart™ Device
n=47 participants at risk
Subjects were administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with technical support for RebiSmart.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Cardiac disorders
Palpitations
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Eye disorders
Retinal disorder
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
General disorders
Administration site pain
|
4.3%
2/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
General disorders
Chills
|
2.2%
1/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
General disorders
Fatigue
|
4.3%
2/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
General disorders
Influenza like illness
|
4.3%
2/46 • Baseline up to Month 12
|
4.3%
2/47 • Baseline up to Month 12
|
|
General disorders
Injection site pain
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
General disorders
Injection site reaction
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
General disorders
Pain
|
2.2%
1/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
General disorders
Pyrexia
|
2.2%
1/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
2/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Infections and infestations
Pneumonia
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Infections and infestations
Urinary tract infection
|
4.3%
2/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Investigations
Hepatic enzyme increased
|
2.2%
1/46 • Baseline up to Month 12
|
10.6%
5/47 • Baseline up to Month 12
|
|
Investigations
Neutralising antibodies
|
2.2%
1/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Nervous system disorders
Headache
|
4.3%
2/46 • Baseline up to Month 12
|
6.4%
3/47 • Baseline up to Month 12
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Nervous system disorders
Migraine
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Nervous system disorders
Multiple sclerosis
|
2.2%
1/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Nervous system disorders
Multiple sclerosis relapse
|
4.3%
2/46 • Baseline up to Month 12
|
4.3%
2/47 • Baseline up to Month 12
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Nervous system disorders
Paraesthesia
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Psychiatric disorders
Depression
|
2.2%
1/46 • Baseline up to Month 12
|
4.3%
2/47 • Baseline up to Month 12
|
|
Psychiatric disorders
Fear of needles
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Psychiatric disorders
Insomnia
|
4.3%
2/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Psychiatric disorders
Mood swings
|
2.2%
1/46 • Baseline up to Month 12
|
4.3%
2/47 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.2%
1/46 • Baseline up to Month 12
|
0.00%
0/47 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/46 • Baseline up to Month 12
|
4.3%
2/47 • Baseline up to Month 12
|
|
Vascular disorders
Hypertension
|
0.00%
0/46 • Baseline up to Month 12
|
2.1%
1/47 • Baseline up to Month 12
|
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