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

18 de junio de 2015 actualizado por: 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).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

61

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Fingolimod
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
Droga: Fingolimod
Cápsula oral de 0,5 mg/día
Otros nombres:
  • GILENYA™
Comparador activo: 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.
Droga: Standard MS DMT
Interferon beta 1a or interferon beta 1b or Glatiramer Acetate
Otros nombres:
  • Avonex®,
  • Copaxone®,
  • Rebif®,
  • Betaferon®,
  • Extavia®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Patient-reported Treatment Satisfaction
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Patient-reported Activities of Daily Living (ADL)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Investigadores

  • Director de estudio: Renato Turrini, MD, Novartis Farma S.p.A.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2011

Finalización primaria (Actual)

1 de junio de 2014

Finalización del estudio (Actual)

1 de junio de 2014

Fechas de registro del estudio

Enviado por primera vez

15 de marzo de 2011

Primero enviado que cumplió con los criterios de control de calidad

15 de marzo de 2011

Publicado por primera vez (Estimar)

16 de marzo de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

22 de junio de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

18 de junio de 2015

Última verificación

1 de junio de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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