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T and B Cell Responses in Autoimmune Diseases (SRA01)

T and B Cell Responses Across Autoimmune Diseases

The study aims to establish whether defects in immune cell function are shared across multiple autoimmune diseases and whether those problems match to similar genes in the cells.

Descripción general del estudio

Descripción detallada

This is a non-randomized, multi-center clinical research study. Subjects who are healthy or have a confirmed or suspected diagnosis of type 1diabetes, multiple sclerosis, psoriasis, Crohn's disease, or rheumatoid arthritis will be asked to donate a blood sample. No follow-ups are planned.

Investigators will:

  • evaluate immune cells from subjects enrolled in this study and match the differences to types of immune cells known to cause autoimmune diseases
  • investigate a particular disease pathway: the IL23R signaling cascade.

Tipo de estudio

De observación

Inscripción (Actual)

68

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

    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06511
        • Yale University
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Emory University
    • New York
      • Manhasset, New York, Estados Unidos, 11030
        • Feinstein Institute for Medical Research
      • Rochester, New York, Estados Unidos, 14642
        • University of Rochester
    • Oklahoma
      • Oklahoma City,, Oklahoma, Estados Unidos, 73104
        • Oklahoma Medical Research Foundation
    • Texas
      • Dallas, Texas, Estados Unidos, 75204
        • Baylor Institute of Immunology Research - Clinical Rheumatology

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

8 años a 60 años (Niño, Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Participants who are healthy or have a confirmed or suspected diagnosis of type 1 diabetes (T1D, T1DM), multiple sclerosis (MS), psoriasis (Ps), Crohn's disease (CD), or rheumatoid arthritis (RA) will be invited to donate a blood sample. No follow-ups are planned.

Descripción

Inclusion Criteria:

-Subject or subject's parent or legal guardian has provided written informed consent

-For healthy donors: Healthy individuals between 18 and 60 years of age, inclusive

  • For all subjects with an autoimmune disease:

    1. Adults between 18 and 60 years, inclusive, diagnosed with or suspected of having one of the following five diseases: adult forms of rheumatoid arthritis (RA), type 1 diabetes (T1D, T1DM), multiple sclerosis (MS), Crohn's disease (CD), Psoriasis (Ps)
    2. Or Children from 8 years up to 18 years inclusive, diagnosed with or suspected of having type 1 diabetes (TID) or Crohn's disease (CD)
    3. Treatment naïve except for prednisone (or equivalent corticosteroid) <\=10mg/day

      4. For subjects diagnosed with type 1 diabetes:

    1. Clinical diagnosis or suspected diagnosis of T1D
    2. Positive per standard clinical titer levels for anti-insulin antibodies if within 10 days of diagnosis (new-onset T1D); and otherwise one of the following antibodies-anti-GAD65, anti-ICA512/IA2 or anti-ZnT8
    3. Minimum body weight 17kg (≥37.5 pounds)
    4. Disease duration within 1 year

      5. For subjects diagnosed with multiple sclerosis:

    a. EDSS (Expanded Disability Status Scale) 0-5 b. Diagnosis or suspected diagnosis of MS as per Dr. Polman et al. Annals of Neurology 2010 c. Disease duration within 1 year

    6. For subjects diagnosed with rheumatoid arthritis (RA):

    a. Diagnosis or suspected diagnosis of RA (2010 ACR criteria) b. Anti-CCP antibody positive c. Disease duration within 1 year

    7. For subjects diagnosed with Crohn's disease:

    a. Clinical diagnosis or suspected diagnosis of Crohn's confirmed by endoscopy b. Disease duration within 1 year c. Minimum body weight 17 kg (≥37.5 pounds)

    8. For subjects diagnosed with psoriasis:

    1. Psoriasis diagnosis by a dermatologist
    2. Disease duration within 1 year
    3. At least two psoriatic plaques or a single plaque occupying at least 1% of total body surface outside scalp

      Exclusion Criteria:

      1. For healthy donors:

    a. Individuals who are unable or unwilling to donate blood samples b. Individuals with self-reported chronic metabolic diseases such as type 2 diabetes, impaired glucose tolerance or morbid obesity c. Individuals with self-reported acute infection (respiratory or others) or chronic infection (such as HIV,hepatitis B or -C) d. Individuals with self-reported immune-mediated diseases such as multiple sclerosis, type 1 diabetes, primary immunodeficiency e. Individuals with self-reported current or prior history of malignancy f. Individuals who are currently pregnant (self-report) g. Corticosteroid therapy equivalent to >/= 10 mg/day of prednisone within the last 4 weeks h. Immunosuppressive therapy at any time prior to enrollment (such as Cyclophosphamide, Mitoxantrone, Imuran, Cellcept, Methotrexate, Rituximab, Alemtuzumab)

    2. For all subjects with an autoimmune disease:

    a. Pregnant patients b. Pediatric patients unable to donate at least 51 mL of blood per NIH guidelines (no more than 5 mL/kg in a single day and no more than 9.5 mL/kg over any 8 week period) c. Patients with current substance abuse or alcoholism (self-report) d. Patients diagnosed with more than one autoimmune and/or inflammatory disease, exception - asthma is permissible e. Corticosteroid therapy equivalent to > 10 mg/day of prednisone within the last 4 weeks f. Immunomodulatory therapies within the last 12 months (such as Interferon, Glatiramer Acetate, Natalizumab, Fingolimod) g. Immunosuppressive medication at any time prior to enrollment (such as Cyclophosphamide, Mitoxantrone, Imuran, Cellcept, Methotrexate, Rituximab, Alemtuzumab) h. Any prior or current Anti-tumor necrosis factor (anti-TNF) treatments i. Any prior or current use of experimental drugs tested in Phase I, II, or III clinical trials

    3. Diagnosis of ulcerative colitis or indeterminate colitis

    4. Pustular psoriasis, isolated palmoplantar psoriasis, isolated inverse psoriasis and isolated sebopsoriasis.

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

Cohortes e Intervenciones

Grupo / Cohorte
Healthy Subjects
Healthy adult controls (no auto-immune disease)
Subjects with Crohn's Disease
Diagnosed with or suspected of having Crohn's disease (CD)
Subjects with Rheumatoid Arthritis
Diagnosed with or suspected of having rheumatoid arthritis (RA)
Subjects with Type 1 diabetes
Diagnosed with or suspected of having type 1 diabetes mellitus (T1D, T1DM)
Subjects with Multiple Sclerosis (MS)
Diagnosed with or suspected of having MS
Subjects with Psoriasis
Diagnosed with or suspected of having psoriasis (Ps)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Identify shared defects in T and B cell function by disease classification
Periodo de tiempo: One-time blood draw
The study aims to establish whether defects in T and B cell function are shared across multiple immune-mediated diseases and whether these are driven by shared genetic risk variants.
One-time blood draw

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Chris Cotsapas, PhD, Yale University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 enero de 2014

Finalización primaria (Actual)

1 de octubre de 2015

Finalización del estudio (Actual)

1 de octubre de 2015

Fechas de registro del estudio

Enviado por primera vez

16 de septiembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

16 de septiembre de 2013

Publicado por primera vez (Estimar)

20 de septiembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

26 de octubre de 2016

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

24 de octubre de 2016

Última verificación

1 de octubre de 2016

Más información

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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