Trial Outcomes & Findings for MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS) (NCT NCT02949908)
NCT ID: NCT02949908
Last Updated: 2019-01-18
Results Overview
TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across a wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 1 to 7, where 1= Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied.
TERMINATED
2 participants
Month 6
2019-01-18
Participant Flow
Two participants were enrolled and the study was prematurely terminated due to low participant recruitment.
Participant milestones
| Measure |
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.
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|---|---|
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Overall Study
STARTED
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2
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.
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Overall Study
Study termination
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2
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
n=2 Participants
Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=2 Participants
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Age, Categorical
Between 18 and 65 years
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2 Participants
n=2 Participants
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Age, Categorical
>=65 years
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0 Participants
n=2 Participants
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Sex: Female, Male
Female
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2 Participants
n=2 Participants
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Sex: Female, Male
Male
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0 Participants
n=2 Participants
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PRIMARY outcome
Timeframe: Month 6Population: Analysis population included participant who received study medication and had data collected at Month 6.
TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across a wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 1 to 7, where 1= Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied.
Outcome measures
| Measure |
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
n=1 Participants
Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.
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Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
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5 Units on a scale
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PRIMARY outcome
Timeframe: Month 12Population: Data was not analyzed for this outcome as the study terminated prematurely due to low subject enrollment and no data was collected for Month 12 assessment.
TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across a wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 1 to 7, where 1= Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Population: Data was not analyzed for this outcome as the study terminated prematurely due to low subject enrollment and no data was collected for Month 12 assessment.
ARR defined as the number of relapses per year. A relapse is defined as the appearance of a new clinical sign or symptom attributable to MS, or clinical worsening of a previous sign or symptom that had been stable for greater than or equal to (\>=) 30 days and that persisted for \>=24 hours without fever.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 6 and Month 12Population: Analysis population: participant who received study medication and had data collected for evaluation. Overall Number of Participants Analyzed = those evaluable for this outcome. Number Analyzed (n) = those evaluable at specified time point and n = 0 signifies no subject was analyzed as study terminated prematurely before Month 12 assessment.
According to the World Health Organization (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).
Outcome measures
| Measure |
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
n=1 Participants
Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.
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Number of Participants With Adherence to Treatment
At Month 6
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1 Participants
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SECONDARY outcome
Timeframe: Month 6, Month 12Population: Analysis population: participant who received study medication and had data collected for evaluation. Overall Number of Participants Analyzed = those evaluable for this outcome. Number Analyzed (n) = those evaluable at specified time point and n = 0 signifies no subject was analyzed as study terminated prematurely before Month 12 assessment.
The MusiQoL is a disease-specific validated 31-item multi-dimensional, self-administered questionnaire. Participants were asked to assess their level of satisfaction with the treatment. Question was answered using a 6-point Likert scale, defined as 1-Never/Not at all, 2-Rarely/A little, 3-Sometimes/Somewhat, 4-Often/A lot, 5-Always/Very much and 6-Not applicable.
Outcome measures
| Measure |
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
n=1 Participants
Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.
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Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Month 6 and 12
Month 6
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4 units on a scale
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SECONDARY outcome
Timeframe: BaselinePopulation: Analysis population included participants who enrolled in this study and had discontinued their initial MS treatment.
Here numbers of participants who discontinued the initial MS treatment (Oral or Injectable) are reported with the reason of discontinuation.
Outcome measures
| Measure |
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
n=1 Participants
Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.
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Number of Participants Discontinued From Initial MS Treatment (Oral or Injectable) by Reason for Discontinuation
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1 Participants
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SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.
TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging 1-7, where 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. ARR= number of relapses per year. Relapse= the appearance of a new clinical sign or symptom attributable to MS, or clinical worsening of a previous sign or symptom that had been stable for greater than or equal to (\>=) 30 days and that persisted for \>=24 hours without fever.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.
TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging 1-7, where 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. According to the World Health Organization (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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.
TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging 1-7, where 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Reasons of discontinuation of initial MS treatment were reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.
The MusiQoL is a disease-specific validated 31-item multi-dimensional, self-administered questionnaire. Participants were asked to assess their level of satisfaction with the treatment. Question was answered using a 6-point Likert scale, defined as 1-Never/Not at all, 2-Rarely/A little, 3-Sometimes/Somewhat, 4-Often/A lot, 5-Always/Very much and 6-Not applicable. ARR= number of relapses per year. Relapse= the appearance of a new clinical sign or symptom attributable to MS, or clinical worsening of a previous sign or symptom that had been stable for greater than or equal to (\>=) 30 days and that persisted for \>=24 hours without fever.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.
The MusiQoL is a disease-specific validated 31-item multi-dimensional, self-administered questionnaire. Participants were asked to assess their level of satisfaction with the treatment. Question was answered using a 6-point Likert scale, defined as 1-Never/Not at all, 2-Rarely/A little, 3-Sometimes/Somewhat, 4-Often/A lot, 5-Always/Very much and 6-Not applicable. According to the World Health Organization (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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.
The MusiQoL is a disease-specific validated 31-item multi-dimensional, self-administered questionnaire. Participants were asked to assess their level of satisfaction with the treatment. Question was answered using a 6-point Likert scale, defined as 1-Never/Not at all, 2-Rarely/A little, 3-Sometimes/Somewhat, 4-Often/A lot, 5-Always/Very much and 6-Not applicable. Reasons of discontinuation of initial MS treatment were reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.
TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across wide variety of medication types and illness conditions. It consists 11 question items used for computing 4 subscales: effectiveness, convenience, side effects and global satisfaction. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging 1-7, where 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. According to the World Health Organization (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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.
TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across wide variety of medication types and illness conditions. It consists 11 question items used for computing 4 subscales: effectiveness, convenience, side effects and global satisfaction. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging 1-7, where 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Reasons of discontinuation of initial MS treatment were reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 6, Month 12Population: Data was not analyzed because study terminated prematurely due to low participant recruitment (only 2 participants enrolled). Month 6 data was available for only 1 participant and none had data collected at Month 12, which did not allow performance of planned analysis. Overall score at Month 6 was collected and is reported under primary outcome 1.
TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across wide variety of medication types and illness conditions. It consists 11 question items used for computing 4 subscales: effectiveness, convenience, side effects and global satisfaction. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging 1-7, where 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Data was not analyzed for this outcome as the study terminated prematurely due to low subject enrollment and no data was collected for Month 12 assessment.
ARR defined as the number of relapses per year. A relapse is defined as the appearance of a new clinical sign or symptom attributable to MS, or clinical worsening of a previous sign or symptom that had been stable for greater than or equal to (\>=) 30 days and that persisted for \>=24 hours without fever.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.
ARR defined as the number of relapses per year. A relapse is defined as the appearance of a new clinical sign or symptom attributable to MS, or clinical worsening of a previous sign or symptom that had been stable for greater than or equal to (\>=) 30 days and that persisted for \>=24 hours without fever. According to the World Health Organization (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).
Outcome measures
Outcome data not reported
Adverse Events
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER