What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Methotrexate, Sulfasalazine, or Hydroxychloroquine. The registry lists allocation as randomized. This study wants to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.
They plan to enroll about 80 people at New York. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Interventions: Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide, Azathioprine, Mycophenolate, Cyclosporine, Tacrolimus, Etanercept, Adalimumab, Golimumab, Certolizumab, Infliximab, Rituximab, Belimumab, Tocilizumab, Anakinra, Canakinumab, Abatacept, Secukinumab, Ixekizumab, Bimekizumab, Ustekinumab, Guselkumab, Risankizumab, Tofacitinib, Upadacitinib
Primary outcome (registry wording): Incidence of wound complications