ClinicalTrials.gov record NCT07138898
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This randomized study assigns people with rheumatic diseases who are having elective total shoulder replacement to either a standard perioperative immunosuppressant hold or a shorter hold. It tracks 90-day outcomes including wound complications, surgical site infections, return to the operating room, and rheumatologic disease flares. The study also measures pain, shoulder function, range of motion, and length of hospital stay.
What it is studying. The study tests whether using a shorter preoperative pause of immunosuppressant medicines (and an earlier postoperative restart) versus the standard, longer pause affects rates of wound problems, superficial and deep surgical site infections, return trips to the operating room, and rheumatologic flares after elective total shoulder arthroplasty.
What the researchers hope to learn. Measure the incidence of wound complications, superficial and deep surgical site infections, return trips to the operating room, and rheumatologic disease flares within 90 days post-op. Also assess hospital length of stay, postoperative pain (VAS), shoulder range of motion, and patient-reported function (PROMIS, ASES, DASH), plus use of rescue medications.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Methotrexate
- Sulfasalazine
- Hydroxychloroquine
- Leflunomide
- Azathioprine
- Mycophenolate
- Cyclosporine
- Tacrolimus
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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 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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
If enrolled you will be randomized to one of two medication-timing plans: a standard perioperative immunosuppressant hold (timing based on published hip/knee guidance) or a shorter, abbreviated hold; the exact preoperative hold and postoperative restart timing depend on the specific drug and are coordinated with your rheumatologist. Postoperative restart is planned at about 2 weeks (±2 days) in the standard group and about 1 week (±2 days) in the shorter-hold group, if the wound is healing and no infection is present. Study visits include the shoulder operation and usual hospital stay, clinic follow-ups and wound checks, pain ratings (VAS) at specified times, shoulder range-of-motion exams, and questionnaires (PROMIS, ASES, DASH); outcomes including wound complications, surgical site infections, return to the operating room, and rheumatologic flares will be tracked for 90 days after surgery. Use of rescue medications or corticosteroid bursts will also be recorded.
How the study is structured. Interventional (treatment) study, randomized and parallel-group with single masking. Participants are assigned to one of two medication-timing plans (standard hold or shorter hold) for a range of commonly used immunosuppressant drugs; outcomes are followed mainly over the first 90 days after surgery. The trial is listed as Phase 2.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on dermatomyositis
This trial is also listed on this site under polymyositis.
Important dates
- Study start
- Dec 12, 2025
- Primary completion
- January 2028 (estimated)
- Study completion
- January 2028 (estimated)
- Target enrollment
- 80 participants (estimated)
- Last updated on registry
- Jul 9, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- NYU Langone Health
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Thomas Chalothron 📞 646-501-7384 ✉ Thomas.Chalothron@nyulangone.org
- Vinay Bijoor 📞 914-610-6112 ✉ Vinay.Bijoor@nyulangone.org
Participating sites (1)
- NYU Langone HealthRecruiting
New York, New York, 10016 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- immunosuppressants
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- observational
- A study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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