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Trial record 60 of 2148 for:    MULTIPLE SCLEROSIS

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 (RebiQoL)

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ClinicalTrials.gov Identifier: NCT01791244
Recruitment Status : Completed
First Posted : February 13, 2013
Results First Posted : July 12, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Multiple Sclerosis
Relapsing-Remitting
Intervention Drug: Rebif®
Enrollment 93
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 46 47
Intent to Treat (ITT) 38 39
Completed 31 29
Not Completed 15 18
Reason Not Completed
Adverse Event             5             7
Insufficient clinical response             10             10
Laboratory Abnormality             0             1
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 38 39 77
Hide Baseline Analysis Population Description
The Intent-to-Treat (ITT) population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 39 participants 77 participants
Between 18 to 72 years 38 39 77
Greater than (>) 72 years 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 39 participants 77 participants
Female
24
  63.2%
24
  61.5%
48
  62.3%
Male
14
  36.8%
15
  38.5%
29
  37.7%
1.Primary Outcome
Title Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12
Hide Description 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.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 35.19  (24.38) 30.48  (20.94)
Change at Month 12 -2.44  (19.38) -3.04  (19.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subject Support Program (MinSupport Plus), Technical Support for the RebiSmart™ Device
Comments Linear mixed model, with baseline value, time, Expanded Disability Status Score (EDSS) at baseline and sex as fixed factors was used for the analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9148
Comments [Not Specified]
Method linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
-8.30 to 9.25
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 35.19  (24.38) 30.48  (20.94)
Change at Month 6 -1.36  (16.82) -1.59  (13.26)
3.Secondary Outcome
Title Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12
Hide Description 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.
Time Frame Baseline, Month 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 21.81  (21.55) 18.01  (16.61)
Change at Month 6 0.56  (9.35) 0.14  (11.19)
Change at Month 12 1.00  (11.34) 0.00  (10.45)
4.Secondary Outcome
Title Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12
Hide Description 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.
Time Frame Baseline, Month 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 8.84  (3.37) 8.03  (2.30)
Change at Month 6 0.18  (2.17) 0.10  (1.76)
Change at Month 12 0.05  (2.51) -0.08  (1.86)
5.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline, Month 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Arm/Group Title Patient Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 71.18  (20.70) 71.49  (16.61)
Change at Month 6 -0.71  (11.36) -3.38  (19.35)
Change at Month 12 -0.84  (16.07) -2.31  (20.60)
6.Secondary Outcome
Title Percentage of Subjects With Treatment Adherence at Month 6 and 12
Hide Description 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.
Time Frame Month 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: Percentage of Subjects
At Month 6 71.05 64.10
At Month 12 65.79 53.85
7.Secondary Outcome
Title Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12
Hide Description 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.
Time Frame Baseline, Month 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.93  (1.75) 3.98  (1.72)
Change at Month 6 0.15  (0.79) 0.05  (0.81)
Change at Month 12 0.13  (0.89) 0.08  (1.09)
8.Secondary Outcome
Title Change From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12
Hide Description 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.
Time Frame Baseline, Month 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 37 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 29.74  (20.50) 31.08  (19.08)
Change at Month 6 3.89  (10.81) 2.27  (9.78)
Change at Month 12 3.75  (10.43) 1.78  (10.65)
9.Secondary Outcome
Title Change From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12
Hide Description 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).
Time Frame Baseline, Month 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Patient Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 37 36
Mean (Standard Deviation)
Unit of Measure: Percentage of fatigue
Baseline 35.40  (24.41) 37.00  (22.72)
Change at Month 6 4.63  (12.87) 2.71  (11.64)
Change at Month 12 4.47  (12.42) 2.12  (12.68)
10.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12
Hide Description 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.
Time Frame Baseline, Month 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (Anxiety Score) 6.13  (4.14) 5.62  (3.21)
Change at Month 6 (Anxiety Score) -0.21  (2.92) -0.56  (2.78)
Change at Month 12 (Anxiety Score) -0.42  (3.48) -0.18  (3.26)
Baseline (Depression Score) 4.26  (3.49) 3.72  (2.77)
Change at Month 6 (Depression Score) 0.61  (2.43) 0.46  (2.85)
Change at Month 12 (Depression Score) 0.42  (3.61) 0.74  (3.14)
11.Secondary Outcome
Title Number of Subjects With Working Ability at Month 12
Hide Description 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.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 32 35
Measure Type: Number
Unit of Measure: Subjects
Subjects with full sickness/disability pension 4 5
Subjects who were employed or had own business 22 25
Subject who were retired 2 2
Subject who were studying 3 2
None of the above 1 1
12.Secondary Outcome
Title Percentage of Subjects With Adverse Events (AE) up to Month 12
Hide Description 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.
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population included all subjects who were randomized and received at least 1 dose of trial treatment.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 46 47
Measure Type: Number
Unit of Measure: Percentage of Subjects
45.7 61.7
13.Secondary Outcome
Title Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12
Hide Description 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.
Time Frame Month 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Subject Support Program (MinSupport Plus)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Subjects
Month 6: Stress: Green; n= 30 2
Month 6: Stress: Orange; n= 30 3
Month 6: Stress: Red; n= 30 3
Month 12: Stress: Green; n= 31 3
Month 12: Stress: Orange; n= 31 2
Month 12: Stress: Red; n= 31 2
Month 6: Alcohol: Green; n= 30 7
Month 6: Alcohol: Orange; n= 30 1
Month 6: Alcohol: Red; n= 30 1
Month 12: Alcohol: Green; n= 32 6
Month 12: Alcohol: Orange; n= 32 6
Month 12: Alcohol: Red; n= 32 6
Month 6: Cost: Green; n= 30 4
Month 6: Cost: Orange; n= 30 4
Month 6: Cost: Red; n= 30 4
Month 12: Cost: Green; n= 32 3
Month 12: Cost: Orange; n= 32 3
Month 12: Cost: Red; n= 32 3
Month 6: Physical: Green; n= 30 5
Month 6: Physical: Orange; n= 30 2
Month 6: Physical: Red; n= 30 1
Month 12: Physical: Green; n= 32 5
Month 12: Physical: Orange; n= 32 1
Month 12: Physical: Red; n= 32 1
Month 6: Activity: Green; n= 30 5
Month 6: Activity: Orange; n= 30 2
Month 6: Activity: Red; n= 30 1
Month 12: Activity: Green; n= 32 5
Month 12: Activity: Orange; n= 32 1
Month 12: Activity: Red; n= 32 1
Month 6: Sleep: Green; n= 30 3
Month 6: Sleep: Orange; n= 30 4
Month 6: Sleep: Red; n= 30 1
Month 12: Sleep: Green; n= 32 3
Month 12: Sleep: Orange; n= 32 2
Month 12: Sleep: Red; n= 32 1
Month 6: Smoking: Green; n= 31 5
Month 6: Smoking: Orange; n= 31 1
Month 6: Smoking: Red; n= 31 1
Month 12: Smoking: Green; n= 32 5
Month 12: Smoking: Orange; n= 32 1
Month 12: Smoking: Red; n= 32 1
14.Secondary Outcome
Title Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12
Hide Description 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”.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 30 33
Measure Type: Number
Unit of Measure: Subjects
Very discontented 1 2
Discontented 6 5
Contented 13 11
Very contented 10 15
15.Secondary Outcome
Title Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12
Hide Description 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”.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Subject Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 18 13
Measure Type: Number
Unit of Measure: Subjects
Very unsatisfied 0 1
Unsatisfied 2 0
Satisfied 10 9
Very satisfied 6 3
16.Secondary Outcome
Title Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12
Hide Description 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?
Time Frame Month 12
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Hide Analysis Population Description
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.
Arm/Group Title Subject Support Program (MinSupport Plus)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: Subjects
Goal 1(G1) : Goal Achieved; n= 38 18
G1: Goal not Achieved; n= 38 4
G1: Missing; n= 38 16
G1 Achieved: Better than Expected; n= 18 5
G1 Achieved: As Expected; n= 18 10
G1 Achieved: Missing; n= 18 3
G1Acheived:Better than Expected:Little Better;n= 5 4
G1Achieved:Better than expected:Lot better; n= 5 0
G1Achieved:Better than Expected: Missing; n= 5 1
G1 not Achieved: Little Less; n= 4 1
G1 not Achieved: Lot Less; n= 4 0
G1 not Achieved: Missing; n= 4 3
Goal 2 (G2): Goal Achieved; n= 38 3
G2: Goal not Achieved; n= 38 1
G2: Missing; n= 38 34
G2 Achieved: Better than Expected; n= 3 2
G2 Achieved: As Expected; n= 3 0
G2 Achieved: Missing; n= 3 1
G2Achieved:Better than Expected:Little Better;n= 2 1
G2 Achieved: Better than Expected:Lot Better; n= 2 1
G2 Achieved: Better than Expected: Missing; n= 2 0
G2 not Achieved: Little Less; n= 1 0
G2 not Achieved: Lot Less; n= 1 1
G2 not Achieved: Missing; n= 1 0
Goal 3 (G3): Goal Achieved; n= 38 0
G3: Goal not Achieved; n= 38 1
G3: Missing; n= 38 37
G3 Achieved: As Expected; n= 0 0
G3 Achieved: Better than Expected; n= 0 0
G3 Achieved: Missing; n= 0 0
G3 Achieved:Better than Expected:Little Better;n=0 0
G3 Achieved:Better than Expected: Lot Better;n=0 0
G3 Achieved: Better than Expected: Missing; n= 0 0
G3 not Achieved: Little Less; n= 1 1
G3 not Achieved: Lot Less; n= 1 0
G3 not Achieved: Missing; n= 1 0
Goal 4 (G4): Goal Achieved; n= 38 0
G4: Goal not Achieved; n= 38 1
G4: Missing; n= 38 37
G4 Achieved: Better than Expected; n= 0 0
G4 Achieved: As Expected; n= 0 0
G4 Achieved: Missing; n= 0 0
G4 Expected:Little Better; n= 0 0
G4Achieved:Better than expected:Lot Better; n= 0 0
G4 Achieved: Better than Expected: Missing; n= 0 0
G4 not Achieved: Little Less; n= 1 0
G4 not Achieved: Lot Less; n= 1 0
G4 not Achieved: Missing; n= 1 1
Time Frame Baseline up to Month 12
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patient Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Patient Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patient Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Affected / at Risk (%) Affected / at Risk (%)
Total   2/46 (4.35%)   0/47 (0.00%) 
Infections and infestations     
Pneumonia * 1  1/46 (2.17%)  0/47 (0.00%) 
Urinary tract infection * 1  2/46 (4.35%)  0/47 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patient Support Program (MinSupport Plus) Technical Support for the RebiSmart™ Device
Affected / at Risk (%) Affected / at Risk (%)
Total   19/46 (41.30%)   29/47 (61.70%) 
Blood and lymphatic system disorders     
Leukopenia * 1  0/46 (0.00%)  1/47 (2.13%) 
Cardiac disorders     
Palpitations * 1  0/46 (0.00%)  1/47 (2.13%) 
Ear and labyrinth disorders     
Vertigo * 1  0/46 (0.00%)  1/47 (2.13%) 
Eye disorders     
Retinal disorder * 1  1/46 (2.17%)  0/47 (0.00%) 
Gastrointestinal disorders     
Aphthous stomatitis * 1  0/46 (0.00%)  1/47 (2.13%) 
Constipation * 1  0/46 (0.00%)  1/47 (2.13%) 
Diarrhoea * 1  1/46 (2.17%)  0/47 (0.00%) 
Gastritis * 1  1/46 (2.17%)  0/47 (0.00%) 
Vomiting * 1  1/46 (2.17%)  0/47 (0.00%) 
General disorders     
Administration site pain * 1  2/46 (4.35%)  0/47 (0.00%) 
Chills * 1  1/46 (2.17%)  1/47 (2.13%) 
Fatigue * 1  2/46 (4.35%)  1/47 (2.13%) 
Influenza like illness * 1  2/46 (4.35%)  2/47 (4.26%) 
Injection site pain * 1  1/46 (2.17%)  0/47 (0.00%) 
Injection site reaction * 1  0/46 (0.00%)  1/47 (2.13%) 
Pain * 1  1/46 (2.17%)  1/47 (2.13%) 
Pyrexia * 1  1/46 (2.17%)  1/47 (2.13%) 
Infections and infestations     
Nasopharyngitis * 1  2/46 (4.35%)  1/47 (2.13%) 
Pneumonia * 1  1/46 (2.17%)  0/47 (0.00%) 
Upper respiratory tract infection * 1  0/46 (0.00%)  1/47 (2.13%) 
Urinary tract infection * 1  2/46 (4.35%)  0/47 (0.00%) 
Injury, poisoning and procedural complications     
Injection related reaction * 1  1/46 (2.17%)  0/47 (0.00%) 
Investigations     
Hepatic enzyme increased * 1  1/46 (2.17%)  5/47 (10.64%) 
Neutralising antibodies * 1  1/46 (2.17%)  1/47 (2.13%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness * 1  0/46 (0.00%)  1/47 (2.13%) 
Musculoskeletal stiffness * 1  1/46 (2.17%)  0/47 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lymphoma * 1  0/46 (0.00%)  1/47 (2.13%) 
Nervous system disorders     
Dizziness * 1  1/46 (2.17%)  0/47 (0.00%) 
Headache * 1  2/46 (4.35%)  3/47 (6.38%) 
Hemiparesis * 1  0/46 (0.00%)  1/47 (2.13%) 
Hypertonia * 1  0/46 (0.00%)  1/47 (2.13%) 
Hypoaesthesia * 1  0/46 (0.00%)  1/47 (2.13%) 
Migraine * 1  0/46 (0.00%)  1/47 (2.13%) 
Multiple sclerosis * 1  1/46 (2.17%)  1/47 (2.13%) 
Multiple sclerosis relapse * 1  2/46 (4.35%)  2/47 (4.26%) 
Neuralgia * 1  0/46 (0.00%)  1/47 (2.13%) 
Paraesthesia * 1  1/46 (2.17%)  0/47 (0.00%) 
Visual field defect * 1  0/46 (0.00%)  1/47 (2.13%) 
Psychiatric disorders     
Depression * 1  1/46 (2.17%)  2/47 (4.26%) 
Fear of needles * 1  1/46 (2.17%)  0/47 (0.00%) 
Insomnia * 1  2/46 (4.35%)  0/47 (0.00%) 
Mood swings * 1  1/46 (2.17%)  2/47 (4.26%) 
Skin and subcutaneous tissue disorders     
Eczema * 1  1/46 (2.17%)  0/47 (0.00%) 
Psoriasis * 1  0/46 (0.00%)  1/47 (2.13%) 
Rash * 1  0/46 (0.00%)  2/47 (4.26%) 
Vascular disorders     
Hypertension * 1  0/46 (0.00%)  1/47 (2.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Merck KGaA Communication Center
Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01791244     History of Changes
Other Study ID Numbers: EMR 200136-560
2012-004887-22 ( EudraCT Number )
First Submitted: February 12, 2013
First Posted: February 13, 2013
Results First Submitted: April 19, 2017
Results First Posted: July 12, 2017
Last Update Posted: August 24, 2017