NCT07138898PHASE2Recruiting
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
NYU Langone Health
Start Date
12/12/2025
Completion Date
1/1/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
1. Adults aged 18 years and older at the time of informed consent;
2. 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;
3. On active immunosuppression for at least 3 months prior to scheduled surgery;
4. Scheduled for elective total shoulder arthroplasty;
5. Able and willing to provide written informed consent prior to any study specific procedures.
Exclusion Criteria:
* Patients with active infections or malignancies;
* Patients undergoing shoulder arthroplasty for fracture or tumor;
* Pregnancy or breastfeeding;
* Unable to provide informed consent;
* 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;
* Unable or without capacity to provide written informed consent prior to any study specific procedures.
Interventions
DRUG
Methotrexate
DRUG
Sulfasalazine
DRUG
Hydroxychloroquine
DRUG
Leflunomide
DRUG
Azathioprine
DRUG
Mycophenolate
DRUG
Cyclosporine
DRUG
Tacrolimus
DRUG
Etanercept
DRUG
Adalimumab
DRUG
Golimumab
DRUG
Certolizumab
DRUG
Infliximab
BIOLOGICAL
Rituximab
BIOLOGICAL
Belimumab
BIOLOGICAL
Tocilizumab
BIOLOGICAL
Anakinra
BIOLOGICAL
Canakinumab
BIOLOGICAL
Abatacept
BIOLOGICAL
Secukinumab
BIOLOGICAL
Ixekizumab
BIOLOGICAL
Bimekizumab
BIOLOGICAL
Ustekinumab
BIOLOGICAL
Guselkumab
BIOLOGICAL
Risankizumab
DRUG
Tofacitinib
DRUG
Upadacitinib
Conditions
Rheumatic Disease
Locations
NYU Langone Health
New York, New York 10016
United States