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Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

NCT ID: NCT07138898
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: NYU Langone Health
Conditions: Rheumatic Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 80 participants (Estimated).

What is being studied

Biological: Abatacept
Intervention: Abatacept
Intervention: Acids, Acyclic
Intervention: Adalimumab
Drug: Adalimumab
Intervention: Amides
Intervention: Amino Acids, Peptides, and Proteins
Intervention: Aminopterin
Intervention: Aminoquinolines
Biological: Anakinra
Intervention: Antibodies
Intervention: Antibodies, Monoclonal
Intervention: Antibodies, Monoclonal, Humanized
Intervention: Antibodies, Monoclonal, Murine-Derived
Drug: Azathioprine
Intervention: Azathioprine
Intervention: Azoles
Intervention: belimumab
Biological: Belimumab
Intervention: bimekizumab
Biological: Bimekizumab
Intervention: Biological Factors
Intervention: Blood Proteins
Intervention: canakinumab
Biological: Canakinumab
Intervention: Caproates
Intervention: Carboxylic Acids
Drug: Certolizumab
Intervention: Certolizumab Pegol
Intervention: Chloroquine
Intervention: Cyclosporine
Drug: Cyclosporine
Intervention: Cyclosporins
Intervention: Cytokines
Drug: Etanercept
Intervention: Etanercept
Intervention: Fatty Acids
Intervention: Globulins
Intervention: golimumab
Drug: Golimumab
Intervention: guselkumab
Biological: Guselkumab
Intervention: Heterocyclic Compounds
Intervention: Heterocyclic Compounds, 1-Ring
Intervention: Heterocyclic Compounds, 2-Ring
Intervention: Heterocyclic Compounds, Fused-Ring
Drug: Hydroxychloroquine
Intervention: Hydroxychloroquine
Intervention: Immunoconjugates
Intervention: Immunoglobulin Constant Regions
Intervention: Immunoglobulin Fab Fragments
Intervention: Immunoglobulin Fc Fragments
Intervention: Immunoglobulin Fragments
Intervention: Immunoglobulins
Intervention: Immunoproteins
Intervention: Infliximab
Drug: Infliximab
Intervention: Intercellular Signaling Peptides and Proteins
Intervention: Interleukin 1 Receptor Antagonist Protein
Intervention: Isoxazoles
Intervention: ixekizumab
Biological: Ixekizumab
Intervention: Lactones
Drug: Leflunomide
Intervention: Leflunomide
Intervention: Lipids
Intervention: Macrocyclic Compounds
Intervention: Macrolides
Intervention: Macromolecular Substances
Intervention: Membrane Proteins
Intervention: Mercaptopurine
Intervention: Methotrexate
Drug: Methotrexate
Drug: Mycophenolate
Intervention: Mycophenolic Acid
Intervention: Nucleic Acids, Nucleotides, and Nucleosides
Intervention: Nucleosides
Intervention: Organic Chemicals
Intervention: Peptide Fragments
Intervention: Peptides
Intervention: Peptides, Cyclic
Intervention: Polycyclic Compounds
Intervention: Polyethylene Glycols
Intervention: Polymers
Intervention: Proteins
Intervention: Pteridines
Intervention: Pterins
Intervention: Purines
Intervention: Quinolines
Intervention: Receptors, Cell Surface
Intervention: Receptors, Cytokine
Intervention: Receptors, Immunologic
Intervention: Receptors, Tumor Necrosis Factor
Intervention: risankizumab
Biological: Risankizumab
Intervention: Rituximab
Biological: Rituximab
Intervention: secukinumab
Biological: Secukinumab
Intervention: Serum Globulins
Intervention: Sulfasalazine
Drug: Sulfasalazine
Intervention: Sulfonamides
Intervention: Sulfones
Intervention: Sulfur Compounds
Drug: Tacrolimus
Intervention: Tacrolimus
Intervention: Thionucleosides
Intervention: tocilizumab
Biological: Tocilizumab
Intervention: tofacitinib
Drug: Tofacitinib
Intervention: upadacitinib
Drug: Upadacitinib
Biological: Ustekinumab
Intervention: Ustekinumab

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

New York, United States: 1

Sample of listed locations

NYU Langone Health — New York, New York, 10016, United States — Recruiting

Study details

Start date: December 12, 2025
Primary completion date: January 1, 2028
Completion date: January 1, 2028
First posted: August 24, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07138898
Registry last updated: July 9, 2026
QualifiedStudies registry data refreshed: October 2, 2026
QualifiedStudies record fetched: October 2, 2026

View NCT07138898 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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