Home › Rheumatoid Arthritis › NCT07138898
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Methotrexate (drug)
- Sulfasalazine (drug)
- Hydroxychloroquine (drug)
- Leflunomide (drug)
- Azathioprine (drug)
- Mycophenolate (drug)
Sponsor: NYU Langone Health · Participants: 80 · Started: Dec 12, 2025
Contact the study team
- Thomas Chalothron · Phone: 646-501-7384
- Vinay Bijoor · Phone: 914-610-6112
Official record on ClinicalTrials.gov — NCT07138898
Locations in the U.S.
| New York | NYU Langone Health, New York |
Conditions
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Lupus
- Juvenile Arthritis
- Giant Cell Arteritis
- Vasculitis
- Granulomatosis with Polyangiitis
- Dermatomyositis
- Polymyositis
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.