Prospective Outcomes Study: Vectra® DA Guided Care Compared to Usual Care

Exclusion Criteria

• •Subjects will be ineligible to participate in the study if they meet any of the following criteria:
• •1. Use of a non-biologic DMARD other than MTX within 3 months prior to enrollment
• •2. MTX administered SQ or as an oral split dose at \>20 mg/week any time during the 3 months prior to enrollment
• •3. Two or more DMARDs used in combination (i.e., concomitantly), including but not limited to: MTX, HCQ, SSZ, LEF, cyclosporine, azathioprine, gold or penicillamine any time prior to enrollment
• •4. Biologic DMARD or JAKi use any time prior to enrollment
• •5. Any contraindication to use of MTX, HCQ, LEF or biologic DMARDs
• •6. Opiate use during the 2 weeks prior to enrollment
• •7. Oral corticosteroids during the month prior to enrollment at a dosage \>10 mg/day prednisone (or equivalent) or at a non-stable dose ≤10 mg/day prednisone (or equivalent)
• •8. MTX intolerance prior to enrollment that limits its use
• •9. Inflammatory joint disease (other than RA) or any other systemic autoimmune disorder. (Osteoarthritis is not a basis for exclusion.)
• •10. Primary or secondary immunodeficiency
• •11. Active infection (excluding fungal infection of nail beds); or acute or chronic infection requiring hospitalization or treatment with parenteral systemic antibiotics within one month of enrollment or treatment with oral antibiotics within 2 weeks of enrollment
• •12. IA, intravenous or IM corticosteroids during the month prior to enrollment
• •13. Initiation or non-stable dosing of NSAIDs within 2 weeks prior to enrollment
• •14. Vectra DA testing within 3 months prior to enrollment
• •15. Live vaccine within 90 days of enrollment
• •16. Active substance abuse or psychiatric illness likely to interfere with protocol conduct
• •17. History of severe allergic or anaphylactic reaction to any monoclonal antibody therapy
• •18. Known infection with HIV (HIV testing will not be a requirement for trial entry); a past or current history of hepatitis B virus or hepatitis C virus infection
• •19. History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ that has been treated or excised in a curative procedure
• •20. Pregnancy or inadequate contraception in women of childbearing potential
• •21. Breast feeding or lactating
• •22. Medical, psychiatric, cognitive or other conditions that, in the opinion of the Investigator, may compromise the ability of the subject to understand the study information, to give informed consent, to comply with the trial protocol, or to complete the study
• •23. Presently enrolled in another clinical trial
• •24. Vectra DA score at screening that is outside the applicable range as required for subject enrollment
• •Note: Screening for TB is not required for subjects participating in the study. If an Investigator is considering a subject for treatment with a biologic DMARD in the study, guidelines for TB screening need to be followed.