T and B Cell Responses in Autoimmune Diseases (SRA01)

October 24, 2016 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • New York
      • Manhasset, New York, United States, 11030
        • Feinstein Institute for Medical Research
      • Rochester, New York, United States, 14642
        • University of Rochester
    • Oklahoma
      • Oklahoma City,, Oklahoma, United States, 73104
        • Oklahoma Medical Research Foundation
    • Texas
      • Dallas, Texas, United States, 75204
        • Baylor Institute of Immunology Research - Clinical Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify shared defects in T and B cell function by disease classification
Time Frame: One-time blood draw
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Autoimmunity Centers of Excellence

Investigators

  • Principal Investigator: Chris Cotsapas, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

September 16, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT SRA01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe