- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01947036
T and B Cell Responses in Autoimmune Diseases (SRA01)
T and B Cell Responses Across Autoimmune Diseases
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Identify shared defects in T and B cell function by disease classification
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Doenças do Sistema Nervoso
- Doenças de pele
- Doenças do sistema imunológico
- Doenças Autoimunes Desmielinizantes, SNC
- Doenças Autoimunes do Sistema Nervoso
- Doenças Desmielinizantes
- Doenças do Sistema Endócrino
- Doenças Gastrointestinais
- Diabetes Mellitus
- Doenças articulares
- Doenças musculoesqueléticas
- Doenças Reumáticas
- Doenças do Tecido Conjuntivo
- Gastroenterite
- Artrite
- Doenças Intestinais
- Doenças de Pele Papuloescamosas
- Doenças Inflamatórias Intestinais
- Esclerose múltipla
- Diabetes Mellitus, Tipo 1
- Artrite, Reumatóide
- Psoríase
- Doença de Crohn
- Doenças autoimunes
Outros números de identificação do estudo
- DAIT SRA01
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .