Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
NCT ID: NCT07138898
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-09-30
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
NCT06028438
A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)
NCT00299546
A Study in Patients With Rheumatoid Arthritis
NCT00966875
Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)
NCT01004432
A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis
NCT04740814
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NYU Langone Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jonathan Samuels, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NYU Langone Health
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
25-00380
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.