This is a study in pre- and peri-menopausal women with onset of rheumatoid arthritis (RA) of less than 3 years duration, to be conducted at the NIH Clinical Center and The General Clinical Research Center of the Johns Hopkins Bayview Medical Center, Baltimore, MD. In this investigation, we hypothesize that the excess of systemically released inflammatory cytokines in RA patients suppresses activity of the GH/IGF-1 axis, and that the combined effects of disordered endocrine-immune function contribute to changes in body composition, endocrine-metabolic and vascular functions thought predisposing to RA-related sarcopenia, osteopenia and increased cardiovascular risk. In phase I of the study, we shall admit RA patients and control subjects to the Clinical Center for a 36 hour period for assessments of the GH/IGF-I axis, cytokines, body composition, endocrine- metabolic and cardiovascular functions, and quality of life. We have initiated Phase I of the study to compare baseline endocrine and inflammatory parameters in RA patients with those in healthy, BMI-matched women. Should the hypotheses in Phase I be satisfied, we plan to conduct a 2nd Phase of the study, in which we shall enroll a new group of RA patients to evaluate the above outcome measures at baseline and after six months of treatment with standard therapy, using one of the available TNF-alpha receptor antagonists that has been approved by the FDA for the treatment of patients with early RA. At present we are enrolling patients and healthy control subjects for entry into Phase I of the study. To date, 1 RA patient and 1 matched control subject have been evaluated. These studies are intended as platform investigations prior to assess the possible impact of various CAM biological agenst, such as DHEA, in RA patients.
