T and B Cell Responses in Autoimmune Diseases



Status:Active, not recruiting
Conditions:Arthritis, Psoriasis, Rheumatoid Arthritis, Infectious Disease, Neurology, Neurology, Gastrointestinal, Diabetes, Diabetes, Crohns Disease, Multiple Sclerosis
Therapuetic Areas:Dermatology / Plastic Surgery, Endocrinology, Gastroenterology, Immunology / Infectious Diseases, Neurology, Rheumatology, Other
Healthy:No
Age Range:8 - 60
Updated:4/21/2016
Start Date:January 2014
End Date:December 2016

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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.

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.

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.
We found this trial at
6
sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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