Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

NCT07138898 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 25-00380
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatic Disease

Keywords

rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; systemic lupus erythematosus; juvenile idiopathic arthritis; spondyloarthritis; polymyalgia rheumatica; giant cell arteritis; vasculitis; granulomatosis with polyangiitis; dermatomyositis; polymyositis; inflammatory bowel disease-associated arthritis

Outcome Measures

Primary Outcomes (5)

• Incidence of wound complications

  90-day post operation

• Incidence of superficial surgical site infections

  90-day post operation

• Incidence of deep surgical site infections

  90-day post operation

• Incidence of return trips to the operating room

  90-day post operation

• Incidence of rheumatologic disease flares

  90-day post operation

Secondary Outcomes (12)

• Length of hospital stay

  From admission to discharge (on average 2 days)

• Postoperative pain score as assessed by the VAS for Pain

  Week 2

• Postoperative pain score as assessed by the VAS for Pain

  Week 6

• Postoperative pain score as assessed by the VAS for Pain

  Month 3

• Change in Range of motion (ROM) - active forward elevation (AFE)

  Week 2, Month 3

Study Arms (2)

Standard hold

ACTIVE COMPARATOR

Patients will follow the standard perioperative immunosuppressant hold protocol based on guidelines from hip and knee arthroplasty literature. The duration of the hold is determined by medication half-life and infection risk considerations. Postoperatively, medications will be restarted approximately 2 weeks after surgery (+/- 2 days), contingent on wound healing and infection status.

Drug: Methotrexate; Drug: Sulfasalazine; Drug: Hydroxychloroquine; Drug: Leflunomide; Drug: Azathioprine; Drug: Mycophenolate; Drug: Cyclosporine; Drug: Tacrolimus; Drug: Etanercept; Drug: Adalimumab; Drug: Golimumab; Drug: Certolizumab; Drug: Infliximab; Biological: Rituximab; Biological: Belimumab; Biological: Tocilizumab; Biological: Anakinra; Biological: Canakinumab; Biological: Abatacept; Biological: Secukinumab; Biological: Ixekizumab; Biological: Bimekizumab; Biological: Ustekinumab; Biological: Guselkumab; Biological: Risankizumab; Drug: Tofacitinib; Drug: Upadacitinib

Shorter hold

EXPERIMENTAL

Patients will follow an abbreviated immunosuppressant hold protocol, withhold durations modified based on drug pharmacokinetics to allow a shorter preoperative discontinuation period. Medications will be prescribed as usual by the patient's rheumatologist, only adjusting the interval between last preoperative dose and surgery. The rheumatologist will relay the number of weeks/days between the last dose and surgery date. Postoperatively, medications will be restarted approximately 1 week after surgery (+/- 2 days), provided there are no signs of infection or wound healing complications. Route of Administration

Drug: Methotrexate; Drug: Sulfasalazine; Drug: Hydroxychloroquine; Drug: Leflunomide; Drug: Azathioprine; Drug: Mycophenolate; Drug: Cyclosporine; Drug: Tacrolimus; Drug: Etanercept; Drug: Adalimumab; Drug: Golimumab; Drug: Certolizumab; Drug: Infliximab; Biological: Rituximab; Biological: Belimumab; Biological: Tocilizumab; Biological: Anakinra; Biological: Canakinumab; Biological: Abatacept; Biological: Secukinumab; Biological: Ixekizumab; Biological: Bimekizumab; Biological: Ustekinumab; Biological: Guselkumab; Biological: Risankizumab; Drug: Tofacitinib; Drug: Upadacitinib

Interventions

Methotrexate DRUG

Continue throughout perioperative period

Shorter hold; Standard hold

Sulfasalazine DRUG

Continue throughout perioperative period

Shorter hold; Standard hold

Hydroxychloroquine DRUG

Continue throughout perioperative period

Also known as: Plaquenil

Shorter hold; Standard hold

Leflunomide DRUG

Continue throughout perioperative period

Also known as: Arava

Shorter hold; Standard hold

Azathioprine DRUG

Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery

Also known as: Imuran

Shorter hold; Standard hold

Mycophenolate DRUG

Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery

Also known as: Cellcept

Shorter hold; Standard hold

Cyclosporine DRUG

Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery

Shorter hold; Standard hold

Tacrolimus DRUG

Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery

Shorter hold; Standard hold

Etanercept DRUG

Control group: Schedule surgery 2 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose

Also known as: Enbrel

Shorter hold; Standard hold

Adalimumab DRUG

Control group: Schedule surgery 3 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose

Also known as: Humira

Shorter hold; Standard hold

Golimumab DRUG

Control group: Schedule surgery 5 weeks after last administered 4-week subcutaneous dose or 9 weeks after last administered 8-week intravenous dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week subcutaneous dose or 4 weeks after last administered 8-week intravenous dose.

Also known as: Simponi

Shorter hold; Standard hold

Certolizumab DRUG

Control group: Schedule surgery 5 weeks after last administered dose. Intervention group: Schedule surgery 2 weeks after last administered dose.

Also known as: Cimzia

Shorter hold; Standard hold

Infliximab DRUG

Control group: Schedule surgery 9 weeks after last administered intravenous dose. Intervention group: Schedule surgery 4 weeks after last administered dose.

Also known as: Remicaide

Shorter hold; Standard hold

Rituximab BIOLOGICAL

Control: Schedule 7 months after last administered dose. Intervention group: Schedule 3 months after last administered dose.

Also known as: Rituxan

Shorter hold; Standard hold

Belimumab BIOLOGICAL

Control group: Schedule surgery 2 weeks after last administered subcutaneous weekly dose or 5 weeks after last administered 4-week intravenous dose. Intervention group: Schedule surgery 1 week after last administered weekly dose or 2 weeks after last administered 4-week dose.

Also known as: Benlysta

Shorter hold; Standard hold

Tocilizumab BIOLOGICAL

Control group: Schedule surgery 2 weeks after last administered subcutaneous weekly dose or 5 weeks after last administered 4-week intravenous dose. Intervention group: Schedule surgery 1 week after last administered weekly dose or 2 weeks after last administered 4-week dose.

Also known as: Actemra

Shorter hold; Standard hold

Anakinra BIOLOGICAL

Control group: Schedule surgery 2 days after last administered daily dose. Experimental group: Schedule surgery 1 day after last administered daily dose.

Also known as: Kineret

Shorter hold; Standard hold

Canakinumab BIOLOGICAL

Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.

Also known as: Ilaris

Shorter hold; Standard hold

Abatacept BIOLOGICAL

Control group: Schedule surgery 2 weeks after last administered weekly subcutaneous dose or 5 weeks after last administered monthly intravenous dose. Intervention group: Schedule surgery 1 week after last administered weekly subcutaneous dose or 2 weeks after last administered monthly intravenous dose.

Also known as: Orencia

Shorter hold; Standard hold

Secukinumab BIOLOGICAL

Control group: Schedule surgery 5 weeks after last administered subcutaneous dose. Intervention group: Schedule surgery 2 weeks after last administered subcutaneous dose.

Also known as: Cosentyx

Shorter hold; Standard hold

Ixekizumab BIOLOGICAL

Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.

Also known as: Taltz

Shorter hold; Standard hold

Bimekizumab BIOLOGICAL

Control group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4 weeks after last administered 8-week dose

Also known as: Bimzelx

Shorter hold; Standard hold

Ustekinumab BIOLOGICAL

Control group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6 weeks after last administered 12-week dose.

Also known as: Stelara

Shorter hold; Standard hold

Guselkumab BIOLOGICAL

Control group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4.5 weeks after last administered 8-week dose.

Also known as: Tremfya

Shorter hold; Standard hold

Risankizumab BIOLOGICAL

Control group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6-7 weeks after last administered 12-week dose.

Also known as: Skyrizi

Shorter hold; Standard hold

Tofacitinib DRUG

Control group: Schedule surgery 4 days after last administered daily dose. Intervention group: Schedule surgery 2 days after last administered daily dose.

Also known as: Xeljanz

Shorter hold; Standard hold

Upadacitinib DRUG

Control group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior to surgery

Also known as: Rinvoq

Shorter hold; Standard hold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Rheumatic Diseases; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Lupus Erythematosus, Systemic; Arthritis, Juvenile; Spondylarthritis; Polymyalgia Rheumatica; Giant Cell Arteritis; Vasculitis; Granulomatosis with Polyangiitis; Dermatomyositis; Polymyositis

Interventions

Methotrexate; Sulfasalazine; Hydroxychloroquine; Leflunomide; Azathioprine; Mycophenolic Acid; Cyclosporine; Tacrolimus; Etanercept; Adalimumab; golimumab; Certolizumab Pegol; Infliximab; Rituximab; belimumab; tocilizumab; Interleukin 1 Receptor Antagonist Protein; canakinumab; Abatacept; secukinumab; ixekizumab; bimekizumab; Ustekinumab; guselkumab; risankizumab; tofacitinib; upadacitinib

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Arthritis; Joint Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis; Muscular Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Skin Diseases, Vascular; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Myositis; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Chloroquine; Aminoquinolines; Quinolines; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Thionucleosides; Mercaptopurine; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Lactones; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Antibodies, Monoclonal, Murine-Derived; Cytokines; Intercellular Signaling Peptides and Proteins; Biological Factors; Immunoconjugates

Study Officials

• Jonathan Samuels, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Chalothron

CONTACT

646-501-7384; Thomas.Chalothron@nyulangone.org

Lauren Drillock

CONTACT

646-501-7388; Lauren.Drillock@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to jonathan.samuels@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (1)