Back to Trials
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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Rheumatic Disease

Locations

NYU Langone Health

New York, New York 10016

United States