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Contemp Clin Trials Commun. 2020 Jan 14;17:100522. doi: 10.1016/j.conctc.2020.100522. eCollection 2020 Mar.

Cohort profile of a US military population for evaluating pre-disease and disease serological biomarkers in rheumatoid and reactive arthritis: Rationale, organization, design, and baseline characteristics.

Contemporary clinical trials communications

Chad K Porter, Mark S Riddle, Renee M Laird, Matthew Loza, Suzanne Cole, Christina Gariepy, Ashley Alcala, Ramiro Gutierréz, Frédéric Baribaud, Navin L Rao, Sunil Nagpal

Affiliations

  1. Enteric Diseases Department, Naval Medical Research Center, Silver Spring, MD, USA.
  2. Henry M. Jackson Foundation for Military Medicine, Bethesda, MD, USA.
  3. Immunology, Janssen Research & Development, Spring House, PA, USA.

PMID: 31989058 PMCID: PMC6971336 DOI: 10.1016/j.conctc.2020.100522

Abstract

PURPOSE: The etiology of several autoimmune disorders, including rheumatoid arthritis, remains unknown. While there are clear phases of disease progression, the mechanisms of transition between these phases are poorly understood. Additionally, treatment focuses on an alteration of the biological processes to prevent joint damage and functional decline. A goal is to potentially treat the disease during the preclinical phase to mitigate the disease process. Reactive arthritis is another rheumatologic condition known to be secondary to a distal infection. While prevention of infection would mitigate risk, serologic profiling patients with the disease may assist in the elucidation of potential disease risk factors. This study was initiated to enable an assessment of pre-disease biomarkers in patients newly diagnosed with rheumatoid arthritis and reactive arthritis.

PARTICIPANTS: A retrospective cohort of 500 rheumatoid and 500 reactive arthritis cases with 500 matched controls was drawn from a population of active component US military personnel. Appropriate inclusion criteria limited subject selection. Additionally, 4 serum samples (3 pre-disease and 1 disease-associated) were obtained for each case and control.

FINDINGS TO DATE: The established cohort provides the framework for novel exploration of the host response through serum profiling and seroepidemiology prior to disease onset.

FUTURE PLANS: This study establishes the framework for the evaluation of novel serum biomarkers enabling the identification of signals prior to clinical disease that may enable disease prediction, elucidate disease pathogenesis and identify novel exposures leading to increased disease risk and/or disease severity.

© 2020 Published by Elsevier Inc.

Keywords: Cohort; Reactive arthritis; Rheumatoid arthritis; Seroepidemiology

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