NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Methotrexate	Continue throughout perioperative period
DRUG	Sulfasalazine	Continue throughout perioperative period
DRUG	Hydroxychloroquine	Continue throughout perioperative period
DRUG	Leflunomide	Continue throughout perioperative period
DRUG	Azathioprine	Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
DRUG	Mycophenolate	Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
DRUG	Cyclosporine	Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
DRUG	Tacrolimus	Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
DRUG	Etanercept	Control group: Schedule surgery 2 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
DRUG	Adalimumab	Control group: Schedule surgery 3 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
DRUG	Golimumab	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.
DRUG	Certolizumab	Control group: Schedule surgery 5 weeks after last administered dose. Intervention group: Schedule surgery 2 weeks after last administered dose.
DRUG	Infliximab	Control group: Schedule surgery 9 weeks after last administered intravenous dose. Intervention group: Schedule surgery 4 weeks after last administered dose.
BIOLOGICAL	Rituximab	Control: Schedule 7 months after last administered dose. Intervention group: Schedule 3 months after last administered dose.
BIOLOGICAL	Belimumab	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.
BIOLOGICAL	Tocilizumab	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.
BIOLOGICAL	Anakinra	Control group: Schedule surgery 2 days after last administered daily dose. Experimental group: Schedule surgery 1 day after last administered daily dose.
BIOLOGICAL	Canakinumab	Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.
BIOLOGICAL	Abatacept	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.
BIOLOGICAL	Secukinumab	Control group: Schedule surgery 5 weeks after last administered subcutaneous dose. Intervention group: Schedule surgery 2 weeks after last administered subcutaneous dose.
BIOLOGICAL	Ixekizumab	Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.
BIOLOGICAL	Bimekizumab	Control group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4 weeks after last administered 8-week dose
BIOLOGICAL	Ustekinumab	Control group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6 weeks after last administered 12-week dose.
BIOLOGICAL	Guselkumab	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.
BIOLOGICAL	Risankizumab	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.
DRUG	Tofacitinib	Control group: Schedule surgery 4 days after last administered daily dose. Intervention group: Schedule surgery 2 days after last administered daily dose.
DRUG	Upadacitinib	Control group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior to surgery

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-08-24
• Last updated: 2025-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study