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

18. juni 2015 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

61

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Fingolimod
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
Legemiddel: Fingolimod
0,5 mg/dag oral kapsel
Andre navn:
  • GILENYA™
Aktiv komparator: 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.
Legemiddel: Standard MS DMT
Interferon beta 1a or interferon beta 1b or Glatiramer Acetate
Andre navn:
  • Avonex®,
  • Copaxone®,
  • Rebif®,
  • Betaferon®,
  • Extavia®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Patient-reported Treatment Satisfaction
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Patient-reported Activities of Daily Living (ADL)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2011

Primær fullføring (Faktiske)

1. juni 2014

Studiet fullført (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først innsendt

15. mars 2011

Først innsendt som oppfylte QC-kriteriene

15. mars 2011

Først lagt ut (Anslag)

16. mars 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

22. juni 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. juni 2015

Sist bekreftet

1. juni 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Forhold

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