T and B Cell Responses Across Autoimmune Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01947036
First received: September 16, 2013
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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. We will look at immune cells from each subject and match the differences to types of immune cells known to cause autoimmune diseases. We will also investigate a particular disease pathway - the IL23R signaling cascade. We want to establish whether alterations to this function are present in multiple diseases.


Condition
Type 1 Diabetes Mellitus
Multiple Sclerosis
Arthritis, Rheumatoid
Crohn Disease
Psoriasis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Incidence of shared defects in T and B cell function [ Time Frame: At time of blood sampling ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 280
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy Subjects
(no auto-immune disease)
Subjects with Crohn's Disease
Subjects with Rheumatoid Arthritis
Subjects with Type 1 diabetes
Subjects with Multiple Sclerosis (MS)
Subjects with Psoriasis

  Eligibility

Ages Eligible for Study:   8 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants who are healthy or have a confirmed or suspected diagnosis of type 1diabetes (T1D), multiple sclerosis (MS), psoriasis (Ps), Crohn's disease (CD), or rheumatoid arthritis (RA). will be asked to donate a blood sample. Around 40 participants per disease group with confirmed diagnosis will be analyzed. No follow-ups are planned.

Criteria

Inclusion Criteria:

  1. Subject or subject's parent or legal guardian has provided written informed consent.
  2. For healthy donors:

    a. Healthy individuals between 18 and 60 years of age, inclusive.

  3. 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 I diabetes (T1D), 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 I diabetes (TID) or Crohn's disease (CD)
    3. Treatment naïve except for prednisone (or equivalent corticosteroid) ≤ 10mg/day
  4. For subjects diagnosed with type 1diabetes:

    1. Clinical diagnosis or suspected diagnosis of type 1 diabetes
    2. Positive per standard clinical titer levels for anti-insulin antibodies if within 10 days of diagnosis; else one of anti-GAD65, anti-ICA512/IA2 or anti-ZnT8 antibodies
    3. Minimum body weight 17kg
    4. Disease duration within 1 year
  5. For subjects diagnosed with multiple sclerosis:

    1. EDSS 0-5
    2. Diagnosis or suspected diagnosis of MS as per Polman et al. Annals of Neurology 2010
    3. Disease duration within 1 year
  6. For subjects diagnosed with rheumatoid arthritis

    1. Diagnosis or suspected diagnosis of RA (2010 ACR criteria)
    2. Anti-CCP antibody positive
    3. Disease duration within 1 year
  7. For subjects diagnosed with Crohn's disease:

    1. Clinical diagnosis or suspected diagnosis of Crohn's confirmed by endoscopy
    2. Disease duration within 1 year
    3. Minimum body weight 17 kg
  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 >1% of total body surface outside scalp

Exclusion Criteria:

  1. For healthy donors:

    1. Individuals who are unable or unwilling to donate blood samples
    2. Individuals with self-reported chronic metabolic diseases such as type 2 diabetes, impaired glucose tolerance or morbid obesity;
    3. Individuals with self-reported infectious diseases such as HIV/AIDS, hepatitis B or C;
    4. Individuals with self-reported immune-mediated diseases such as multiple sclerosis, type 1 diabetes, primary immunodeficiency,
    5. Individuals with self-reported current or prior history of malignancy
    6. Individuals who are currently pregnant (self-report).
    7. Corticosteroid therapy equivalent to ≥ 10 mg/day of prednisone within the last 4 weeks
    8. 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:

    1. Pregnant patients
    2. 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)
    3. Patients with current substance abuse or alcoholism (self-report)
    4. Patients diagnosed with more than one autoimmune and/or inflammatory disease, asthma is permissible
    5. Current acute infection (respiratory or others), chronic infection (such as HIV, Hepatitis B or C)
    6. Corticosteroid therapy equivalent to > 10 mg/day of prednisone within the last 4 weeks
    7. Immunomodulatory therapies within the last 12 months (such as Interferon, Glatiramer Acetate, Natalizumab, Fingolimod)
    8. Immunosuppressive medication at any time prior to enrollment (such as Cyclophosphamide, Mitoxantrone, Imuran, Cellcept, Methotrexate, Rituximab, Alemtuzumab)
    9. Any prior or current Anti-tumor necrosis factor (anti-TNF) treatments
    10. Any prior or current use of experimental drugs tested in Phase I, II, or III trials
  3. Diagnosis of ulcerative colitis or indeterminate colitis
  4. Pustular psoriasis, isolated palmoplantar psoriasis, isolated inverse psoriasis and isolated sebopsoriasis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947036

Contacts
Contact: Arpita Singh 203-737-7453 arpita.singh@yale.edu

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
Contact: Arpita Singh    203-737-7453      
Principal Investigator: Chris Cotsapas, PhD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jennifer Scantlin    404-712-2943    jennifer.scantlin@emory.edu   
Contact: Julie F. Kozarsky       jkozars@emory.edu   
Principal Investigator: Ignacio Sanz, MD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Michelle G. Smith    585-275-1634    michelleg_smith@urmc.rochester.edu   
Contact: Barbara Johnson, RN    585 276 3513    barbara_johnson@urmc.rochester.edu   
Principal Investigator: R. John Looney, MD         
Sub-Investigator: Nicholas Jospe, MD         
United States, Oklahoma
Oklahoma Medical Research Foundation Recruiting
Oklahoma City,, Oklahoma, United States, 73104
Contact: Micki Moore       Micki-Moore@omrf.org   
Principal Investigator: Judith James, MD, PhD         
United States, Texas
Baylor Institute of Immunology Research Not yet recruiting
Dallas, Texas, United States, 75204
Contact: Jeanine Baisch    214-820-7454    jeaninba@baylorhealth.edu   
Principal Investigator: Virginia Pascual, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Chris Cotsapas, PhD Yale University
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01947036     History of Changes
Other Study ID Numbers: DAIT SRA01
Study First Received: September 16, 2013
Last Updated: May 30, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Crohn Disease
Multiple Sclerosis
Arthritis, Rheumatoid
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune 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

ClinicalTrials.gov processed this record on September 16, 2014