TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset

Exclusion Criteria

• •1. Current treated or untreated major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, dementias of any type, and alcoholism or drug abuse (as determined by self-report, SAGE-SR, and Ham-D)
• •2. Known allergy to mifepristone, misoprostol, or medicines that contain misoprostol, such as Cytotec or Arthrotec.
• •3. Current heavy alcohol or tobacco use (self-report). Alcohol consumption not to exceed approximately 15 drinks per week (with a drink defined as 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) and tobacco use not to exceed 20 cigarettes (or equivalent) per day.
• •4. Current organ failure (as determined by metabolic panel and self-report)
• •5. Current treated or untreated rheumatologic and inflammatory disorders, as determined by medical diagnosis of one or more of the following: osteoarthritis, rheumatoid arthritis (RA), lupus, spondyloarthropathies -- ankylosing spondylitis (AS) and psoriatic arthritis (PsA), Sjogren's syndrome, gout, scleroderma, infectious arthritis, and polymyalgia rheumatic
• •6. Chronic active infections such as HIV, hepatitis B, and hepatitis C (as determined by antibody tests
• •7. History of organ transplant (self-report)
• •8. Current untreated primary sleep disorders such as insomnias, sleep related breathing disorders, etc. (self-report)
• •9. History of tuberculosis exposure (determined by QuantiFERON-TB® positivity)
• •10. Use of medications that could affect immune function (e.g., steroids, immunosuppressants) or limit the interpretation of the exercise challenge (self- report)
• •11. Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine \> 2.0 mg/dL or eGFR \< 44; or currently on renal dialysis).
• •12. Hepatic insufficiency (bilirubin \>2.5mg/dL or transaminases \>5x the ULN) Subjects with Gilberts syndrome are eligible for the study if other liver function tests are normal, regardless of bilirubin level.
• •14. Are scheduled for surgery within 24 weeks of study enrollment.
• •15. Cushing's disease or salivary cortisol level greater than 0.812 ug/dL.
• •16. QT prolongation, as evidenced by medical history (self-report) or ECG at screening.
• •17. Uncontrolled diabetes (A1c\>7.5).
• •Prohibited concomitant or prior therapies:
• •1. Immunosuppressant drugs, including glucocorticoid taper, topical/inhaled glucocorticoids
• •2. Currently on dialysis
• •3. Recipient of bone marrow or organ transplant
• •4. Previous or current treatment with angiogenic growth factors, cytokines, gene or stem cell therapy
• •5. Participating in another interventional clinical trial of an investigational therapy within 8 weeks prior to consent to participate in this study, or planning to participate in another interventional clinical trial of an investigational therapy within 26 weeks after consent to participate in this study
• •6. Any herbal medicine that contains licorice root.
• •7. Selective Blood thinners:
• •* Only Apixaban and Warfarin will be included. Rivaroxaban cannot be included as there are higher drug to drug interactions as well as Apixaban 2.5 mg BID.
• •* If a participant is on Warfarin, a baseline INR will be obtained, the Warfarin dose will be reduced and an INR will be rechecked 48-72 hours after starting Mifepristone.
• •* If a participant is on Apixaban, the dose must be reduced by 50%.
• •* Please note that if participants are taking anticoagulants, there is a potential interaction that could lead to possible increased on risk of bleeding and will require more frequent monitoring by the Coordinator.