Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
68 participants
OBSERVATIONAL
2014-01-31
2015-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Healthy Subjects
Healthy adult controls (no auto-immune disease)
No interventions assigned to this group
Subjects with Crohn's Disease
Diagnosed with or suspected of having Crohn's disease (CD)
No interventions assigned to this group
Subjects with Rheumatoid Arthritis
Diagnosed with or suspected of having rheumatoid arthritis (RA)
No interventions assigned to this group
Subjects with Type 1 diabetes
Diagnosed with or suspected of having type 1 diabetes mellitus (T1D, T1DM)
No interventions assigned to this group
Subjects with Multiple Sclerosis (MS)
Diagnosed with or suspected of having MS
No interventions assigned to this group
Subjects with Psoriasis
Diagnosed with or suspected of having psoriasis (Ps)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
-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:
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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
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.
8 Years
60 Years
ALL
Yes
Sponsors
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Autoimmunity Centers of Excellence
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Chris Cotsapas, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Feinstein Institute for Medical Research
Manhasset, New York, United States
University of Rochester
Rochester, New York, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Baylor Institute of Immunology Research - Clinical Rheumatology
Dallas, Texas, United States
Countries
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Related Links
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National Institute of Allergy and Infectious Diseases (NIAID) website
Other Identifiers
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DAIT SRA01
Identifier Type: -
Identifier Source: org_study_id