Status:
NOT_YET_RECRUITING
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Lead Sponsor:
NYU Langone Health
Conditions:
Rheumatic Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07138898
Start Date
September 1 2025
End Date
September 1 2027
Last Update
August 24 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016