- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01947036
T and B Cell Responses in Autoimmune Diseases (SRA01)
T and B Cell Responses Across Autoimmune Diseases
Descripción general del estudio
Estado
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
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06511
- Yale University
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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New York
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Manhasset, New York, Estados Unidos, 11030
- Feinstein Institute for Medical Research
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Rochester, New York, Estados Unidos, 14642
- University of Rochester
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Oklahoma
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Oklahoma City,, Oklahoma, Estados Unidos, 73104
- Oklahoma Medical Research Foundation
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Texas
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Dallas, Texas, Estados Unidos, 75204
- Baylor Institute of Immunology Research - Clinical Rheumatology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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:
- 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)
- 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)
Treatment naïve except for prednisone (or equivalent corticosteroid) <\=10mg/day
4. For subjects diagnosed with type 1 diabetes:
- Clinical diagnosis or suspected diagnosis of T1D
- 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
- Minimum body weight 17kg (≥37.5 pounds)
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:
- Psoriasis diagnosis by a dermatologist
- Disease duration within 1 year
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
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Healthy Subjects
Healthy adult controls (no auto-immune disease)
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Subjects with Crohn's Disease
Diagnosed with or suspected of having Crohn's disease (CD)
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Subjects with Rheumatoid Arthritis
Diagnosed with or suspected of having rheumatoid arthritis (RA)
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Subjects with Type 1 diabetes
Diagnosed with or suspected of having type 1 diabetes mellitus (T1D, T1DM)
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Subjects with Multiple Sclerosis (MS)
Diagnosed with or suspected of having MS
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Subjects with Psoriasis
Diagnosed with or suspected of having psoriasis (Ps)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Identify shared defects in T and B cell function by disease classification
Periodo de tiempo: One-time blood draw
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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.
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One-time blood draw
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Chris Cotsapas, PhD, Yale University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Enfermedades del Sistema Nervioso
- Enfermedades de la piel
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Enfermedades del sistema endocrino
- Enfermedades Gastrointestinales
- Diabetes mellitus
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades reumáticas
- Enfermedades del tejido conectivo
- Gastroenteritis
- Artritis
- Enfermedades intestinales
- Enfermedades De La Piel Papuloescamosa
- Enfermedades inflamatorias del intestino
- Esclerosis múltiple
- Diabetes Mellitus, Tipo 1
- Artritis Reumatoide
- Soriasis
- Enfermedad de Crohn
- Enfermedades autoinmunes
Otros números de identificación del estudio
- DAIT SRA01
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