Clinical Trial Results:
Prospective Phase IV Clinical Trial on Effectiveness and adherence to Rebif Treatment of CIS and RMS Patients in Romania by using Electronic Device RebiSmart®
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Summary
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EudraCT number |
2014-001290-14 |
Trial protocol |
RO |
Global end of trial date |
02 Jan 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Sep 2017
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First version publication date |
08 Sep 2017
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
EMR 200136_583
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02254304 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Merck KGaA
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Sponsor organisation address |
Frankfurter Strasse 250, Darmstadt, Germany, 64293
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Public contact |
Merck KGaA, Communication Center Merck KGaA, +49 6151725200, service@merckgroup.com
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Scientific contact |
Merck KGaA, Communication Center Merck KGaA, +49 6151725200, service@merckgroup.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Jan 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Jan 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Jan 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate effectiveness and adherence to treatment in patients with CIS and in patients with relapsing multiple sclerosis (RMS) using RebiSmart® to self-inject Rebif® in multi dose cartridge.
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Protection of trial subjects |
Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Dec 2014
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
3 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Romania: 106
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Worldwide total number of subjects |
106
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EEA total number of subjects |
106
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
106
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
The study was conducted at 7 sites in Romania. | |||||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Rebif In RMS Subjects | |||||||||||||||||||||||||||||||||
Arm description |
Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Rebif
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Investigational medicinal product code |
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Other name |
Interferon beta-1a
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Rebif was administered in RMS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months
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Arm title
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Rebif in CIS Subjects | |||||||||||||||||||||||||||||||||
Arm description |
Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Rebif
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Investigational medicinal product code |
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Other name |
Interferon beta-1a
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Rebif was administered in CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
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Baseline characteristics reporting groups
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Reporting group title |
Rebif In RMS Subjects
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Reporting group description |
Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Rebif in CIS Subjects
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Reporting group description |
Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Rebif In RMS Subjects
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Reporting group description |
Rebif was administered in subjects with Relapsing Multiple Sclerosis (RMS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. | ||
Reporting group title |
Rebif in CIS Subjects
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Reporting group description |
Rebif was administered in subjects with Clinically Isolated Syndromes (CIS) at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. | ||
Subject analysis set title |
Rebif in RMS and CIS Subjects
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Rebif was administered in RMS and CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
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End point title |
Percentage of Relapse-free RMS Subjects [1] [2] | ||||||||
End point description |
A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Relapse-free RMS subjects were those who did not had relapse during 12 month treatment period. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Data was planned to be reported for "Rebif in RMS Subjects" arm.
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End point type |
Primary
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End point timeframe |
Month 12
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As the endpoint is descriptive in nature, no statistical analysis is provided. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only arms which are applicable to the endpoint are reported. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to the First Relapse for CIS Subjects [3] [4] | ||||||||
End point description |
A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to MS, accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Time to the First Relapse was defined as the duration from start of the treatment until first relapse. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Data was planned to be reported for "Rebif in CIS Subjects" arm. 99999 = Median Kaplan Meier time to first relapse and inter-quartile range was not reached in the study because relapse was reported in only 1 subject.
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End point type |
Primary
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End point timeframe |
Baseline up to 12 months
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As the endpoint is descriptive in nature, no statistical analysis is provided. [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only arms which are applicable to the endpoint are reported. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects With Treatment Adherence | |||||||||||||||||||||||||||
End point 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 treatment adherence under different categories (<=50%, >50-75%, >75-90%, >90%) were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With Relapse by Adherence Category | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with relapses by adherence categories (<=50%, >50-75%, >75-90%, >90%) were presented. Adherence missing are the subjects who withdrew before 12 months and who did not have any relapses before withdrawal. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of subjects who Prematurely Terminated Treatment and Reasons | |||||||||||||||||||||||||||||||||
End point description |
Percentage of subjects who prematurely terminated treatment and reasons were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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End point type |
Secondary
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End point timeframe |
Baseline up to 12 months
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects Free From Clinical Disease Activity | ||||||||||||
End point description |
Data could not be analyzed for this outcome because this is a composite outcome dependent on subjects free from relapses and Expanded Disability Status Scale (EDSS) progression, where EDSS progression requires to be collected every 3/6 months and confirmed 3/6 months later. Since EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated.
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End point type |
Secondary
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End point timeframe |
Baseline up to 12 months
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| Notes [5] - EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated [6] - EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects Free from Disability Progression | ||||||||||||
End point description |
Data could not be analyzed for this outcome because this Expanded Disability Status Scale (EDSS) progression requires EDSS to be collected every 3/6 months and confirmed 3/6 months later. Since EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated.
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End point type |
Secondary
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End point timeframe |
Baseline up to 12 months
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| Notes [7] - EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated. [8] - EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Mean Number of Relapses in RMS Subjects [9] | ||||||||
End point description |
A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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End point type |
Secondary
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End point timeframe |
Month 12
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| Notes [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only arms which are applicable to the endpoint are reported. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects With Reasons of Missed Injections | ||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Number of subjects with the reasons of missed injections were presented. Aspartate transaminase and alanine transaminase are abbreviated as ALT and AST respectively. Glutamic oxaloacetic transaminase and glutamic pyruvic transaminase are abbreviated as GOT and GPT respectively. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects who missed the injections are evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Baseline up to 12 months
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Overall Evaluation of RebiSmart use as Assessed by Investigator | |||||||||||||||||||||||||||
End point description |
Evaluation of RebiSmart was categorized under very easy, quite easy, Neither easy nor difficult, very difficult and missing. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects due to Multiple Sclerosis (MS) | ||||||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of visits to clinic by subjects due to MS were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects who visited clinic for MS.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit | |||||||||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Subjects who took consultations with specialists, general practitioners for MS were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "Number of Subjects Analyzed" signifies number of subjects who visited to doctors for MS.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subject's Home | ||||||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of visits by healthcare professional to subject's home were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room due to Multiple Sclerosis (MS) | ||||||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of times subjects visited emergency room due to MS were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects analyzed” signifies number of subjects evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized due to Multiple Sclerosis (MS) | ||||||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of days subjects hospitalized due to MS were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them due to Multiple Sclerosis (MS) | |||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who paid someone to assist them due to MS were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | ||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Days per Week Assistant Worked For Subject due to Multiple Sclerosis (MS) | ||||||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of days per week assistant worked for subject due to MS were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure.Here "99999" signifies data was not available because standard deviation could not be estimated as there was only 1 subject analysed.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Hours per Day Assistant Worked for Subject due to Multiple Sclerosis (MS) | ||||||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of hours per week assistant worked for subject due to MS were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure. Here "99999" signifies data was not available because standard deviation could not be estimated as there was only 1 subject analysed.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work due to Subjects Multiple Sclerosis (MS) | |||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects whose relatives or friends missed work due to subjects' MS were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | ||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend due to Subjects' Multiple Sclerosis (MS) | ||||||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of working days missed by relative or friend due to subjects' MS were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure. Here "99999" signifies Standard deviation could not be estimated as there was only 1 subject analyzed.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed any Full Days From Work due to Multiple Sclerosis (MS). | |||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who missed any full days from work due to MS were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | ||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects | ||||||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of full days missed from work by subjects were presented. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed any Partial Days From Work due to Multiple Sclerosis (MS). | |||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who missed any partial days from work due to MS were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | ||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Hours per day Missed From Work by Subjects | ||||||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of hours per day missed from work by subjects were presented. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here "99999" signifies data was not available because standard deviation could not be estimated as there was only 1 subject analysed.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work due to Multiple Sclerosis (MS) | |||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects accomplished less work due to MS were presented. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | ||||||||||
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End point title |
Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work completed Despite of Multiple Sclerosis (MS) | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Amount of work done by subjects in spite of multiple sclerosis was presented under different percentages (0-100%). Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Subjects Analyzed” signifies number of subjects evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with Medication Adherence based on Morisky Medication Adherence Score | ||||||||||||||||||
End point description |
The Morisky Medication Adherence Scale (MMAS) is a valid and reliable instrument that consists of 8 items that measure medication adherence. The scores of the MMAS-8 range from 0 to 8. This self-report scale consists of 7 items answered with a yes or no and 1 item with a 5-point Likert scale. A score below 6 indicates low adherence, a score between 6 to < 8 indicates medium adherence and a score of 8 indicates high adherence. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Subjects With Adverse Event or Adverse Drug Reaction (AE/ADR), Serious AE/ADR, AE/ADR Leading to Death and AE/ADR Leading to Early Termination | ||||||||||||||
End point description |
An AE was any untoward medical occurrence in a subject or clinical investigation in a subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to the drug treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AE/ADR was planned to be reported for both the arms together. Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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End point type |
Secondary
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End point timeframe |
Baseline up to 12 months
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Expanded Disability Status Scale (EDSS) Score | ||||||||||||||||||
End point description |
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Body Mass Index (BMI) | ||||||||||||
End point description |
BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2). Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 12
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Baseline up to 12 months
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Adverse event reporting additional description |
AE/ADR was planned to be reported for both the arms together.
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Assessment type |
Non-systematic | ||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
Rebif in RMS and CIS Subjects
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Reporting group description |
Rebif was administered in RMS and CIS subjects at a dose of 44 mcg subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months. | ||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
