Who is eligible for clinical trial NCT07138898?

Participants must meet the protocol's inclusion criteria for Rheumatic Disease. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07138898 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-07

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty (NCT07138898)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: NYU Langone Health

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (7 items).

Location: NYU Langone Health — New York, New York

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

NYU Langone Health — New York, New York

📞 Contact the Study Coordinator

Phone: (646) 501-7384

Email: Thomas.Chalothron@nyulangone.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗