Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print Created with Sketch. YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon

Inicie sesión o únase ahora para utilizar esta función

Recruiting

Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-β or No Disease Modifying Therapy - RPC-1063-MS-010

Actualizada: 15 abril, 2022   |   ClinicalTrials.gov

Celgene es una filial íntegramente participada por Bristol-Myers Squibb Company

Imprimir Resumen

¿ESTÁ CONSIDERANDO PARTICIPAR EN ESTE ESTUDIO?
Imprima esta página y la guía del estudio para poder hablar mejor con su médico.
Use la guía de estudios para explorar el proceso de participación en un estudio clínico. Comprenda qué factores clave debe considerar antes de decidirse y piense preguntas para hacerle a su equipo de atención médica.

Detalles del estudio

  • Phase 3

    Fase

  • Géneros

  • 18-55

    Rango de edad

  • 32

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Cohort 1 - non-pegylated interferon-β or no disease modifying therapy
Biological: Tetanus, diphtheria, and acellular pertussis vaccine Biological: Seasonal influenza vaccine Biological: Pneumococcal polysaccharide vaccine
Experimental: Cohort 1 - Ozanimod
Biological: Tetanus, diphtheria, and acellular pertussis vaccine Biological: Seasonal influenza vaccine Biological: Pneumococcal polysaccharide vaccine
Experimental: Cohort 2 - non-pegylated interferon-β or no disease modifying therapy
Biological: Tetanus, diphtheria, and acellular pertussis vaccine Biological: Pneumococcal polysaccharide vaccine
Experimental: Cohort 2 - Ozanimod
Biological: Tetanus, diphtheria, and acellular pertussis vaccine Biological: Pneumococcal polysaccharide vaccine

Criterios clave de elegibilidad

Inclusion Criteria: - Participant has a diagnosis of multiple sclerosis (MS) according to the 2017 revision of the McDonald diagnostic criteria and has relapsing forms of multiple sclerosis (RMS): relapsing-remitting MS (RRMS) or secondary progressive MS with active disease based on recent clinical relapse or MRI lesion activity. Exclusion Criteria: - Participant has history of cancer, including solid tumors and hematological except for basal cell cancer of the skin and carcinoma in situ of the cervix, which are exclusionary if they have not been excised and resolved. - Participant has a history of or currently active primary or secondary immunodeficiency. - Participant has severely compromised cardiac or pulmonary function for which a systemic hypersensitivity reaction to any of the vaccines would pose a significant risk. - Participant has received the seasonal influenza vaccine for the 2021/2022 influenza season prior to Day 1, or history of influenza vaccine for the 2020/2021 influenza season within 6 months prior to Day 1. - Participant has previous treatment with one of the following medications or interventions within the corresponding timeframe described as follows: - Any systemic immunosuppressive treatments with potential overlapping effects with the baseline of this study. Corticosteroids that are by non-systemic routes (e.g., topical, inhaled, intra-articular) are allowed. - History of treatment with IV immunoglobulin (IVIg) or plasmapheresis within 4 weeks prior to Day 1.

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

¿Tiene alguna pregunta? El soporte en vivo está disponible 24/7 - Llame 855-907-3286 o Envíenos un correo electrónico

¿Tiene alguna pregunta? El soporte en vivo está disponible 24/7 -
Llame 855-907-3286 o Envíenos un correo electrónico