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

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

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Rebif

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• Germany
  • Darmstadt, Germany, 64293
    • Please contact the Merck KGaA Communication Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

RRMS participants who have discontinued their initial MS treatment and for whom MS treatment will be required according to the decision of the Health Care Professional and participant.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)	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.	Month 6
Treatment Satisfaction Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)	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.	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Relapse Rate (ARR)	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.	Month 12
Number of Participants With Adherence to Treatment	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).	Month 6 and Month 12
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Month 6 and 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.	Month 6, Month 12
Number of Participants Discontinued From Initial MS Treatment (Oral or Injectable) by Reason for Discontinuation	Here numbers of participants who discontinued the initial MS treatment (Oral or Injectable) are reported with the reason of discontinuation.	Baseline
Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Annualized Relapse Rate (ARR)	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.	up to 12 months
Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Adherence	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).	up to 12 months
Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Reason for Discontinuation	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.	up to 12 months
Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Annualized Relapse Rate (ARR)	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.	up to 12 months
Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Adherence	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).	up to 12 months
Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Reason for Discontinuation	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.	up to 12 months
Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Adherence	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).	up to 12 months
Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Reasons for Discontinuation	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.	up to 12 months
Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscale Score at Month 6 and 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.	Baseline, Month 6, Month 12
Change From Baseline in Annualized Relapse Rate (ARR) at 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.	Baseline, Month 12
Correlation Between Annualized Relapse Rate (ARR) and Treatment Adherence	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).	up to 12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2017
• Primary Completion (Actual): August 25, 2017
• Study Completion (Actual): August 25, 2017

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Relapsing Remitting Multiple Sclerosis; Rebif; Treatment Satisfaction Questionnaire for Medication Version II; Multiple Sclerosis International Quality of Life Questionnaire
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: EMR200136_597