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

7 augusti 2018 uppdaterad av: Merck KGaA, Darmstadt, Germany

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Läkemedel: 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.
Andra namn:
  • IFNβ-1b

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
Tidsram: 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.
Month 6
Treatment Satisfaction Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
Tidsram: 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.
Month 12

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Annualized Relapse Rate (ARR)
Tidsram: 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.
Month 12
Number of Participants With Adherence to Treatment
Tidsram: 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).
Month 6 and Month 12
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Month 6 and 12
Tidsram: 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.
Month 6, Month 12
Number of Participants Discontinued From Initial MS Treatment (Oral or Injectable) by Reason for Discontinuation
Tidsram: Baseline
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)
Tidsram: 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.
up to 12 months
Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Adherence
Tidsram: 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).
up to 12 months
Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Reason for Discontinuation
Tidsram: 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.
up to 12 months
Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Annualized Relapse Rate (ARR)
Tidsram: 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.
up to 12 months
Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Adherence
Tidsram: 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).
up to 12 months
Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Reason for Discontinuation
Tidsram: 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.
up to 12 months
Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Adherence
Tidsram: 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).
up to 12 months
Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Reasons for Discontinuation
Tidsram: 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.
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
Tidsram: 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.
Baseline, Month 6, Month 12
Change From Baseline in Annualized Relapse Rate (ARR) at Month 12
Tidsram: 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.
Baseline, Month 12
Correlation Between Annualized Relapse Rate (ARR) and Treatment Adherence
Tidsram: 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).
up to 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Merck KGaA, Darmstadt, Germany

Samarbetspartners

Merck B.V., Netherlands

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

9 februari 2017

Primärt slutförande (Faktisk)

25 augusti 2017

Avslutad studie (Faktisk)

25 augusti 2017

Studieregistreringsdatum

Först inskickad

17 oktober 2016

Först inskickad som uppfyllde QC-kriterierna

27 oktober 2016

Första postat (Uppskatta)

31 oktober 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 januari 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 augusti 2018

Senast verifierad

1 juli 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • EMR200136_597

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