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Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change (EPOC)

18 juni 2015 bijgewerkt door: Novartis Pharmaceuticals

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)

The purpose of this study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

61

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Italië
      • Novara, Italië, 28100
        • Novartis Investigative Site
    • AN
      • Ancona, AN, Italië, 60126
        • Novartis Investigative Site
    • BI
      • Ponderano, BI, Italië, 13900
        • Novartis Investigative Site
    • CL
      • Caltanissetta, CL, Italië, 93100
        • Novartis Investigative Site
    • CN
      • Cuneo, CN, Italië, 12100
        • Novartis Investigative Site
    • CO
      • Como, CO, Italië, 22100
        • Novartis Investigative Site
    • CT
      • Catania, CT, Italië, 95122
        • Novartis Investigative Site
    • FG
      • Foggia, FG, Italië, 71100
        • Novartis Investigative Site
    • FI
      • Castelfiorentino, FI, Italië, 50051
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italië, 20133
        • Novartis Investigative Site
      • Milano, MI, Italië, 20122
        • Novartis Investigative Site
      • San Donato Milanese, MI, Italië, 20097
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italië, 41100
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italië, 90146
        • Novartis Investigative Site
      • Palermo, PA, Italië, 90129
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italië, 56126
        • Novartis Investigative Site
    • VR
      • Legnago, VR, Italië, 37045
        • Novartis Investigative Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria.
  • Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
  • An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive.
  • Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
  • Naïve to treatment with fingolimod.

Exclusion Criteria:

  • A manifestation of MS other than those defined in the inclusion criteria.
  • A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  • Patients with uncontrolled diabetes mellitus (HbA1c > 7%).
  • Diagnosis of macular edema during Screening Phase.

Other protocol-defined inclusion/exclusion criteria may apply

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Fingolimod
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
Geneesmiddel: Fingolimod
0,5 mg/dag orale capsule
Andere namen:
  • GILENYA™
Actieve vergelijker: Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
Geneesmiddel: Standard MS DMT
Interferon beta 1a or interferon beta 1b or Glatiramer Acetate
Andere namen:
  • Avonex®,
  • Copaxone®,
  • Rebif®,
  • Betaferon®,
  • Extavia®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Patient-reported Treatment Satisfaction
Tijdsspanne: baseline, 6 months
The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.
baseline, 6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Patient-reported Activities of Daily Living (ADL)
Tijdsspanne: baseline, 6 months
The PRIMUS activity measure is a 15-item assessment used to evaluate patient-reported activities of daily living. The PRIMUS activities score was calculated summing the 15 items, after recoding the responses from 1 - 3 to 0 - 2. Therefore, the total score ranged from 0 - 3-, where high scores were indicative of greater function limitation. A negative change from baseline indicates improvement.
baseline, 6 months
Change From Baseline in Patient-reported Fatigue
Tijdsspanne: 6 months
The fatigue Severity Scale (FSS) is a 9-item scale used to assess fatigue. The FSS score was calculated summing the 9 items of the questionnaire and dividing by the number of non-missing items (each item is based on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)). A negative change from baseline indicates improvement.
6 months
Change From Baseline in Patient-Reported Effectiveness and Convenience
Tijdsspanne: 6 months
The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.
6 months
Change From Baseline in Patient-reported Depression
Tijdsspanne: 6 months
The Beck Depression Inventory Fast Screen (BDI-FS) is a brief, multiple choice, self reported inventory designed to evaluate depression in patients with medical illness. The BDI-FS score was calculated summing the 7 items of the questionnaire. Each item ranged from 0 (not present) to 3 (severe). The total score ranges from 0-3 (minimal depression), 4-8 (mild depression), 9-12 (moderate depression) and 13-21 (severe depression). A negative change from baseline indicates improvement.
6 months
Change From Baseline in Patient-reported Health Related Quality of Life (QOL)
Tijdsspanne: 6 months
The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, pain, general health, energy/fatigue, social functioning, role limitations due to emotional problems and emotional well-being. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.
6 months
Physician-reported Clinical Global Impression of Improvement (CGI-I)
Tijdsspanne: 6 months
The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. A lower score and a negative change from baseline indicate improvement.
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Onderzoekers

  • Studie directeur: Renato Turrini, MD, Novartis Farma S.p.A.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2011

Primaire voltooiing (Werkelijk)

1 juni 2014

Studie voltooiing (Werkelijk)

1 juni 2014

Studieregistratiedata

Eerst ingediend

15 maart 2011

Eerst ingediend dat voldeed aan de QC-criteria

15 maart 2011

Eerst geplaatst (Schatting)

16 maart 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

22 juni 2015

Laatste update ingediend die voldeed aan QC-criteria

18 juni 2015

Laatst geverifieerd

1 juni 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CFTY720DIT02
  • 2010-024017-31 (EudraCT-nummer)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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