Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Recruiting · NCT07138898 · Interventional (participants receive a specific treatment) · Lead sponsor: NYU Langone Health
View the official record on ClinicalTrials.gov →Interventions studied
AbataceptAdalimumabAnakinraAzathioprineBelimumabBimekizumabCanakinumabCertolizumabCyclosporineEtanerceptGolimumabGuselkumabHydroxychloroquineInfliximabIxekizumabLeflunomideMethotrexateMycophenolateRisankizumabRituximabSecukinumabSulfasalazineTacrolimusTocilizumabTofacitinibUpadacitinibUstekinumab
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed across 1 US state.
- NYU Langone Health - New York, New York, United States
- NYU Langone Health - New York, New York, United States