Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07138898
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Rheumatic Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate — DRUG
    Continue throughout perioperative period
  • Sulfasalazine — DRUG
    Continue throughout perioperative period
  • Hydroxychloroquine — DRUG
    Continue throughout perioperative period
  • Leflunomide — DRUG
    Continue throughout perioperative period
  • Azathioprine — DRUG
    Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
  • Mycophenolate — DRUG
    Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
  • Cyclosporine — DRUG
    Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
  • Tacrolimus — DRUG
    Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
  • Etanercept — DRUG
    Control group: Schedule surgery 2 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
  • Adalimumab — DRUG
    Control group: Schedule surgery 3 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
  • 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.
  • Certolizumab — DRUG
    Control group: Schedule surgery 5 weeks after last administered dose. Intervention group: Schedule surgery 2 weeks after last administered dose.
  • Infliximab — DRUG
    Control group: Schedule surgery 9 weeks after last administered intravenous dose. Intervention group: Schedule surgery 4 weeks after last administered dose.
  • Rituximab — BIOLOGICAL
    Control: Schedule 7 months after last administered dose. Intervention group: Schedule 3 months after last administered dose.
  • 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.
  • 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.
  • Anakinra — BIOLOGICAL
    Control group: Schedule surgery 2 days after last administered daily dose. Experimental group: Schedule surgery 1 day after last administered daily dose.
  • 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.
  • 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.
  • Secukinumab — BIOLOGICAL
    Control group: Schedule surgery 5 weeks after last administered subcutaneous dose. Intervention group: Schedule surgery 2 weeks after last administered subcutaneous dose.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • Tofacitinib — DRUG
    Control group: Schedule surgery 4 days after last administered daily dose. Intervention group: Schedule surgery 2 days after last administered daily dose.
  • Upadacitinib — DRUG
    Control group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior to surgery

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard hold
    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.
  • Experimental: Shorter hold
    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

Primary Outcome Measure

Incidence of wound complications [ Time Frame: 90-day post operation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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