TerminatedNot Applicable

T and B Cell Responses in Autoimmune Diseases

Stopped: Lack of enrollment.

United States68 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range8 Years – 60 Years

SexALL

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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
✓. 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
✓. 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)

What they're measuring

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

Timeframe: One-time blood draw

Trial details

NCT IDNCT01947036

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2015-10

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus trials