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Taking people in United StatesPhase 2

Immunosuppressant Timing Before Elective Shoulder Replacement in Rheumatology Patients

Compares stopping immunosuppressant drugs for longer versus shorter periods before shoulder replacement in rheumatic disease.

Plain-language title generated from the registry record
Registry title: Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Key facts

Where
New York, United StatesSee the site
Phase
Phase 2

Where in United States

  • NYU Langone HealthNew York, United StatesTaking people

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Trial details

Who runs it
NYU Langone Health
Trial code
NCT07138898
Record updated
9 July 2026
Original description
The purpose of this study is 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.Read full original descriptionShow less

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

The purpose of this study is 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.

Inclusion: Adults aged 18 years and older at the time of informed consent; Diagnosis of rheumatic disease: rheumatoid arthritis (RA), psoriatic arthritis (PA) , ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), spondyloarthritis, polymyalgia rheumatica, giant cell arteritis, vasculitis, granulomatosis with polyangiitis, dermatomyositis, polymyositis, and inflammatory bowel disease-associated arthritis; On active immunosuppression for at least 3 months prior to scheduled surgery; Scheduled for elective total shoulder arthroplasty; Able and willing to provide written informed consent prior to any study specific procedures.

Exclusion: Unable or without capacity to provide written informed consent prior to any study specific procedures; Patients with active infections or malignancies; Patients with severe SLE with marked activity - as they should be offered enrollment in the observational arm. All such patients should remain on treatment to avoid worsening of disease activity; Patients undergoing shoulder arthroplasty for fracture or tumor; Pregnancy or breastfeeding; Unable to provide informed consent.

ClinicalTrials.gov NCT07138898