Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

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

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

Sponsors & Collaborators

• NYU Langone Health

  lead OTHER

Principal Investigators

• Jonathan Samuels, MD · NYU Langone Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2027-09-30

Completion

2027-09-30

FDA Drug

Yes

Countries

• United States

Study Locations