Recruiting
Phase 2

Immunosuppressants vs. Shorter Hold

Sponsor:

NYU Langone Health

Code:

NCT07138898

Conditions

Rheumatic Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Methotrexate

Sulfasalazine

Hydroxychloroquine

Leflunomide

Azathioprine

Study Details

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

Study ID

NCT07138898

Start date

Dec 12, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Methotrexate

Continue throughout perioperative period

Sulfasalazine

Continue throughout perioperative period

Hydroxychloroquine

Continue throughout perioperative period

Leflunomide

Continue throughout perioperative period

Azathioprine

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

Mycophenolate

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

Cyclosporine

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

Tacrolimus

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

Etanercept

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

Adalimumab

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

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.

Certolizumab

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

Infliximab

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

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

Rituximab

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

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.

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.

Anakinra

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

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.

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.

Secukinumab

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

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

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.

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

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.

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.

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.

Tofacitinib

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

Upadacitinib

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

Primary outcome measure

  • Incidence of wound complications [ Time Frame: 90-day post operation ]
  • Incidence of superficial surgical site infections [ Time Frame: 90-day post operation ]
  • Incidence of deep surgical site infections [ Time Frame: 90-day post operation ]
  • Incidence of return trips to the operating room [ Time Frame: 90-day post operation ]
  • Incidence of rheumatologic disease flares [ Time Frame: 90-day post operation ]

Central Contacts and Locations

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-09.