- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02949908
MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS) (MESTRE-MS)
7. august 2018 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Darmstadt, Tyskland, 64293
- Please contact the Merck KGaA Communication Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)
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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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
Tidsramme: Month 6
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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.
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Month 6
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Treatment Satisfaction Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
Tidsramme: 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.
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Month 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Annualized Relapse Rate (ARR)
Tidsramme: Month 12
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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.
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Month 12
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Number of Participants With Adherence to Treatment
Tidsramme: Month 6 and Month 12
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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).
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Month 6 and Month 12
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Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Month 6 and 12
Tidsramme: Month 6, Month 12
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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.
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Month 6, Month 12
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Number of Participants Discontinued From Initial MS Treatment (Oral or Injectable) by Reason for Discontinuation
Tidsramme: Baseline
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Here numbers of participants who discontinued the initial MS treatment (Oral or Injectable) are reported with the reason of discontinuation.
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Baseline
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Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Annualized Relapse Rate (ARR)
Tidsramme: 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.
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up to 12 months
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Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Adherence
Tidsramme: 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).
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up to 12 months
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Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Reason for Discontinuation
Tidsramme: 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.
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up to 12 months
|
Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Annualized Relapse Rate (ARR)
Tidsramme: 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.
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up to 12 months
|
Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Adherence
Tidsramme: 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
Tidsramme: 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.
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up to 12 months
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Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Adherence
Tidsramme: 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
Tidsramme: 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.
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up to 12 months
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Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscale Score at Month 6 and Month 12
Tidsramme: 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.
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Baseline, Month 6, Month 12
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Change From Baseline in Annualized Relapse Rate (ARR) at Month 12
Tidsramme: 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
Tidsramme: 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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Medical Responsible, Merck B.V., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
9. februar 2017
Primær færdiggørelse (Faktiske)
25. august 2017
Studieafslutning (Faktiske)
25. august 2017
Datoer for studieregistrering
Først indsendt
17. oktober 2016
Først indsendt, der opfyldte QC-kriterier
27. oktober 2016
Først opslået (Skøn)
31. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. januar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. august 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EMR200136_597
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Multipel sclerose
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City of Hope Medical CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeKlassisk Hodgkin lymfom | Lymfocytrigt klassisk Hodgkin-lymfom | Ann Arbor Stage IB Hodgkin lymfom | Ann Arbor Stage II Hodgkin lymfom | Ann Arbor Stage IIA Hodgkin lymfom | Ann Arbor Stage IIB Hodgkin lymfom | Ann Arbor Stage I Hodgkin lymfom | Ann Arbor Stage I Mixed Cellularity Klassisk Hodgkin-lymfom og andre forholdForenede Stater
Kliniske forsøg med Rebif
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EMD SeronoAfsluttetMultipel scleroseForenede Stater
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Merck KGaA, Darmstadt, GermanyAfsluttetMultipel sclerose | Tilbagefaldende-RemitterendeSverige, Tyskland
-
EMD SeronoAfsluttetMultipel scleroseItalien, Den Russiske Føderation, Forenede Stater, Argentina, Venezuela, Canada, Tunesien, Frankrig
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EMD SeronoTrukket tilbageRecidiverende-remitterende multipel sklerose
-
University of North Carolina, Chapel HillAfsluttetMultipel scleroseForenede Stater
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EMD SeronoAfsluttetMultipel sklerose, recidiverende-remitterendeForenede Stater
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Merck KGaA, Darmstadt, GermanyEMD Serono Canada Inc.AfsluttetKlinisk isoleret syndromCanada
-
Merck KGaA, Darmstadt, GermanyGesellschaft für Therapieforschung mbHAfsluttet
-
Merck KGaA, Darmstadt, GermanyMerck spol.s.r.o., Czech RepublicAfsluttetMultipel sklerose, recidiverende-remitterendeTjekkiet
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Merck KGaA, Darmstadt, GermanyAfsluttetRecidiverende-remitterende multipel skleroseTyskland, Estland, Letland, Litauen, Finland, Østrig, Danmark, Holland, Portugal, Schweiz, Norge, Italien