T and B Cell Responses in Autoimmune Diseases

NCT01947036 | Terminated

• 1 other identifier: DAIT SRA01
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus; Multiple Sclerosis; Arthritis, Rheumatoid; Crohn's Disease; Psoriasis

Keywords

autoimmune disease; immune-mediated disease; T and B cells immunophenotype; IL23 signaling; genetic risk variants

Outcome Measures

Primary Outcomes (1)

• Identify shared defects in T and B cell function by disease classification

  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.

  One-time blood draw

Study Arms (6)

Healthy Subjects

Healthy adult controls (no auto-immune disease)

Subjects with Crohn's Disease

Diagnosed with or suspected of having Crohn's disease (CD)

Subjects with Rheumatoid Arthritis

Diagnosed with or suspected of having rheumatoid arthritis (RA)

Subjects with Type 1 diabetes

Diagnosed with or suspected of having type 1 diabetes mellitus (T1D, T1DM)

Subjects with Multiple Sclerosis (MS)

Diagnosed with or suspected of having MS

Subjects with Psoriasis

Diagnosed with or suspected of having psoriasis (Ps)

Eligibility Criteria

• Age: 8 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants who are healthy or have a confirmed or suspected diagnosis of type 1 diabetes (T1D, T1DM), multiple sclerosis (MS), psoriasis (Ps), Crohn's disease (CD), or rheumatoid arthritis (RA) will be invited to donate a blood sample. No follow-ups are planned.

You may qualify if:

• 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
• \. For subjects diagnosed with type 1 diabetes:
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• 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
• \. 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
• \. For subjects diagnosed with rheumatoid arthritis (RA):

You may not qualify if:

• \. 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)
• \. 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
• \. Diagnosis of ulcerative colitis or indeterminate colitis
• \. Pustular psoriasis, isolated palmoplantar psoriasis, isolated inverse psoriasis and isolated sebopsoriasis.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Autoimmunity Centers of Excellence: collaborator

Study Sites (6)

Yale University

New Haven, Connecticut, 06511, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Baylor Institute of Immunology Research - Clinical Rheumatology

Dallas, Texas, 75204, United States

Location

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID) website

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Multiple Sclerosis; Arthritis, Rheumatoid; Crohn Disease; Psoriasis; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Chris Cotsapas, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 20, 2013
• Study Start: January 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

US (6)