MESTRE-MS: MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS)

• Sponsor: Merck KGaA, Darmstadt, Germany (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02949908
• Collaborator: Merck B.V., Netherlands (Industry)
• Enrollment: 2
• Location: 1
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a prospective, multicenter, open label, uncontrolled, non-interventional, single arm study to measure treatment satisfaction of relapsing remitting MS (RRMS) participants on Rebif after discontinuing initial first-line treatment.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Rebif

Study Design

• Study Type: Observational
• Actual Enrollment: 2 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Phase IV, Prospective, Multicenter, Open Label, Uncontrolled, Non-interventional, Single Arm Study to Measure Treatment Satisfaction of Multiple Sclerosis (MS) Patients on Rebif® After Discontinuing Initial First-line Treatment
• Actual Study Start Date: Feb 9, 2017
• Actual Primary Completion Date: Aug 25, 2017
• Actual Study Completion Date: Aug 25, 2017

Arms and Interventions

Arm

Intervention/Treatment

Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)

Drug: Rebif; 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.; Other Names: IFNβ-1b

Outcome Measures

Primary Outcome Measures

1. Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) [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.

2. Treatment Satisfaction Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) [Month 12]

   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.

Secondary Outcome Measures

1. Annualized Relapse Rate (ARR) [Month 12]

   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.

2. Number of Participants With Adherence to Treatment [Month 6 and Month 12]

   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).

3. Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Month 6 and 12 [Month 6, Month 12]

   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.

4. Number of Participants Discontinued From Initial MS Treatment (Oral or Injectable) by Reason for Discontinuation [Baseline]

   Here numbers of participants who discontinued the initial MS treatment (Oral or Injectable) are reported with the reason of discontinuation.

5. Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Annualized Relapse Rate (ARR) [up to 12 months]

   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.

6. Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Adherence [up to 12 months]

   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).

7. Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Reason for Discontinuation [up to 12 months]

   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.

8. Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Annualized Relapse Rate (ARR) [up to 12 months]

   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.

9. Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Adherence [up to 12 months]

   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).

10. Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Reason for Discontinuation [up to 12 months]

    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.

11. Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Adherence [up to 12 months]

    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).

12. Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Reasons for Discontinuation [up to 12 months]

    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.

13. Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscale Score at Month 6 and Month 12 [Baseline, Month 6, Month 12]

    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.

14. Change From Baseline in Annualized Relapse Rate (ARR) at Month 12 [Baseline, Month 12]

    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.

15. Correlation Between Annualized Relapse Rate (ARR) and Treatment Adherence [up to 12 months]

    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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female, 18 to 65 years of age (both inclusive), at the time of informed consent

• Participants diagnosed with RRMS according to McDonald criteria 2010

• Participants have discontinued treatment with dimethyl fumarate (Tecfidera), teriflunomide (Aubagio), glatiramer acetate (Copaxone®), intramuscular IFNβ-1a (Avonex®), pegylated interferon (Plegridy®), subcutaneous IFNβ-1b (Betaferon®) or fingolimod (Gilenya®) within 6 months prior to Visit 1

• Currently treated with Rebif using RebiSmart 2.0, for a maximum of 6 months prior to Visit 1

• Participants have a score on the Expanded Disability Status Scale (EDSS) between 0 to 5.0 inclusive

• Participants willing and able to give informed consent.

Exclusion Criteria:

• Participants have known planned surgical procedures at the time of the informed consent that will prevent adherence to treatment with Rebif through RebiSmart 2.0

• Participants diagnosed with primary progressive, secondary progressive, or progressive relapsing MS

• pregnant or lactating, or planning to become pregnant subjects

• In the opinion of the Investigator has significant renal or hepatic impairment or other significant disease (e.g., cognitive or visual impairment) that would compromise adherence and completion of the study

• Reports any reason that he/she cannot complete the 1 year study

• Participants have a history of hypersensitivity to natural or recombinant interferon, or any other component of the formulation

• Participants who contraindicated for the treatment with subcutaneous IFNβ-1a therapy as per summary of product characteristics or currently approved specific country product information

• Participants have any other factor that in the opinion of the Investigator would make the subject unsuitable for participation in this study

• Participants have significant psychiatric symptoms that, in the opinion of the Investigator, would impact patient ability to comply with treatment recommendations.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Please Contact the Merck KGaA Communication Center	Darmstadt		Germany	64293

Sponsors and Collaborators

• Merck KGaA, Darmstadt, Germany
• Merck B.V., Netherlands

Investigators

• Study Director: Medical Responsible, Merck B.V., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany

Study Documents (Full-Text)

• Study Protocol - Oct 7, 2016
• Statistical Analysis Plan - May 12, 2017

More Information

Publications

None provided.

• Responsible Party: Merck KGaA, Darmstadt, Germany
• ClinicalTrials.gov Identifier: NCT02949908
• Other Study ID Numbers: EMR200136_597
• First Posted: Oct 31, 2016
• Last Update Posted: Jan 18, 2019
• Last Verified: Jul 1, 2018

• Keywords provided by Merck KGaA, Darmstadt, Germany: Relapsing Remitting Multiple Sclerosis; Rebif; Treatment Satisfaction Questionnaire for Medication Version II; Multiple Sclerosis International Quality of Life Questionnaire
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

Participant Flow

Recruitment Details	Two participants were enrolled and the study was prematurely terminated due to low participant recruitment.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	2 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
Description	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.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Analysis population included participant who received study medication and had data collected at Month 6.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	1
Number [Units on a scale]	5

2. Primary Outcome

Title	Treatment Satisfaction Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
Description	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.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

3. Secondary Outcome

Title	Annualized Relapse Rate (ARR)
Description	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.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

4. Secondary Outcome

Title	Number of Participants With Adherence to Treatment
Description	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).
Time Frame	Month 6 and Month 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	1
At Month 6	1 50%

5. Secondary Outcome

Title	Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Month 6 and 12
Description	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.
Time Frame	Month 6, Month 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	1
Month 6	4

6. Secondary Outcome

Title	Number of Participants Discontinued From Initial MS Treatment (Oral or Injectable) by Reason for Discontinuation
Description	Here numbers of participants who discontinued the initial MS treatment (Oral or Injectable) are reported with the reason of discontinuation.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Analysis population included participants who enrolled in this study and had discontinued their initial MS treatment.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	1
Count of Participants [Participants]	1 50%

7. Secondary Outcome

Title	Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Annualized Relapse Rate (ARR)
Description	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.
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

8. Secondary Outcome

Title	Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Adherence
Description	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).
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

9. Secondary Outcome

Title	Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Reason for Discontinuation
Description	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.
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

10. Secondary Outcome

Title	Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Annualized Relapse Rate (ARR)
Description	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.
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

11. Secondary Outcome

Title	Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Adherence
Description	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).
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

12. Secondary Outcome

Title	Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Reason for Discontinuation
Description	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.
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

13. Secondary Outcome

Title	Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Adherence
Description	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).
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

14. Secondary Outcome

Title	Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Reasons for Discontinuation
Description	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.
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

15. Secondary Outcome

Title	Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscale Score at Month 6 and Month 12
Description	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.
Time Frame	Baseline, Month 6, Month 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

16. Secondary Outcome

Title	Change From Baseline in Annualized Relapse Rate (ARR) at Month 12
Description	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.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

17. Secondary Outcome

Title	Correlation Between Annualized Relapse Rate (ARR) and Treatment Adherence
Description	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).
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
Measure Participants	0

Adverse Events

Time Frame	Up to 7 Months
Arm/Group Title	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Arm/Group Description	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.
All Cause Mortality
	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

The study was prematurely terminated due to low recruitment (only 2 participants were enrolled). Therefore, no statistical analysis was performed on the limited data which was collected during the study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.