- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01947036
T and B Cell Responses in Autoimmune Diseases (SRA01)
T and B Cell Responses Across Autoimmune Diseases
Panoramica dello studio
Stato
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06511
- Yale University
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University
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New York
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Manhasset, New York, Stati Uniti, 11030
- Feinstein Institute for Medical Research
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Rochester, New York, Stati Uniti, 14642
- University of Rochester
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Oklahoma
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Oklahoma City,, Oklahoma, Stati Uniti, 73104
- Oklahoma Medical Research Foundation
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Texas
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Dallas, Texas, Stati Uniti, 75204
- Baylor Institute of Immunology Research - Clinical Rheumatology
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Identify shared defects in T and B cell function by disease classification
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Chris Cotsapas, PhD, Yale University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Malattie del sistema nervoso
- Malattie della pelle
- Malattie del sistema immunitario
- Malattie autoimmuni demielinizzanti, SNC
- Malattie autoimmuni del sistema nervoso
- Malattie demielinizzanti
- Malattie del sistema endocrino
- Malattie gastrointestinali
- Diabete mellito
- Malattie articolari
- Malattie muscoloscheletriche
- Malattie reumatiche
- Malattie del tessuto connettivo
- Gastroenterite
- Artrite
- Malattie intestinali
- Malattie della pelle, papulosquamose
- Malattie infiammatorie intestinali
- Sclerosi multipla
- Diabete mellito, tipo 1
- Artrite, reumatoide
- Psoriasi
- Malattia di Crohn
- Malattie autoimmuni
Altri numeri di identificazione dello studio
- DAIT SRA01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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