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

7 sierpnia 2018 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: Kohorta
  • Perspektywy czasowe: Spodziewany

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
Lek: 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.
Inne nazwy:
  • IFNβ-1b

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Annualized Relapse Rate (ARR)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Merck KGaA, Darmstadt, Germany

Współpracownicy

Merck B.V., Netherlands

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

9 lutego 2017

Zakończenie podstawowe (Rzeczywisty)

25 sierpnia 2017

Ukończenie studiów (Rzeczywisty)

25 sierpnia 2017

Daty rejestracji na studia

Pierwszy przesłany

17 października 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 października 2016

Pierwszy wysłany (Oszacować)

31 października 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 stycznia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 sierpnia 2018

Ostatnia weryfikacja

1 lipca 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • EMR200136_597

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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