Managing immunosuppressants around shoulder replacement in rheumatic disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial examines how stopping certain immunosuppressants before elective total shoulder arthroplasty affects rheumatic disease patients. It compares stopping for a preoperative period aligned with hip/knee arthroplasty guidelines to stopping for a shorter preoperative window, looking at flare rates, pain scores, functional outcomes, wound complications, infections, and return to the operating room. Adults with rheumatic diseases on active immunosuppression scheduled for shoulder replacement are eligible. Interventions include methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, and azathioprine. The lead sponsor is NYU Langone Health, with study sites at NYU Langone Health in New York.

Why it matters

Who can join: the full rules

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.

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jonathan Samuels, MD — NYU Langone Health
• Study coordinator: Thomas Chalothron
• Email: Thomas.Chalothron@nyulangone.org
• Phone: 646-501-7384

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.