Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Purpose
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.
Condition
Eligibility
- Eligible Ages
-
Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
-
No
Inclusion Criteria
- 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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|
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.
|
-
Drug: Methotrexate
Continue throughout perioperative period
-
Drug: Sulfasalazine
Continue throughout perioperative period
-
Drug: Hydroxychloroquine
Continue throughout perioperative period
Other names:
-
Drug: Leflunomide
Continue throughout perioperative period
Other names:
-
Drug: Azathioprine
Control group: Withhold the daily dose 1 week prior to surgery Intervention group:
Withhold 2 days prior to surgery
Other names:
-
Drug: Mycophenolate
Control group: Withhold the daily dose 1 week prior to surgery Intervention group:
Withhold 2 days prior to surgery
Other names:
-
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
Other names:
-
Drug: Adalimumab
Control group: Schedule surgery 3 weeks after last administered dose Intervention group:
Schedule surgery 1 week after last administered dose
Other names:
-
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.
Other names:
-
Drug: Certolizumab
Control group: Schedule surgery 5 weeks after last administered dose. Intervention group:
Schedule surgery 2 weeks after last administered dose.
Other names:
-
Drug: Infliximab
Control group: Schedule surgery 9 weeks after last administered intravenous dose.
Intervention group: Schedule surgery 4 weeks after last administered dose.
Other names:
-
Biological: Rituximab
Control: Schedule 7 months after last administered dose. Intervention group: Schedule 3
months after last administered dose.
Other names:
-
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.
Other names:
-
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.
Other names:
-
Biological: Anakinra
Control group: Schedule surgery 2 days after last administered daily dose. Experimental
group: Schedule surgery 1 day after last administered daily dose.
Other names:
-
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.
Other names:
-
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.
Other names:
-
Biological: Secukinumab
Control group: Schedule surgery 5 weeks after last administered subcutaneous dose.
Intervention group: Schedule surgery 2 weeks after last administered subcutaneous dose.
Other names:
-
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.
Other names:
-
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
Other names:
-
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.
Other names:
-
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.
Other names:
-
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.
Other names:
-
Drug: Tofacitinib
Control group: Schedule surgery 4 days after last administered daily dose. Intervention
group: Schedule surgery 2 days after last administered daily dose.
Other names:
-
Drug: Upadacitinib
Control group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior
to surgery
Other names:
|
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
|
-
Drug: Methotrexate
Continue throughout perioperative period
-
Drug: Sulfasalazine
Continue throughout perioperative period
-
Drug: Hydroxychloroquine
Continue throughout perioperative period
Other names:
-
Drug: Leflunomide
Continue throughout perioperative period
Other names:
-
Drug: Azathioprine
Control group: Withhold the daily dose 1 week prior to surgery Intervention group:
Withhold 2 days prior to surgery
Other names:
-
Drug: Mycophenolate
Control group: Withhold the daily dose 1 week prior to surgery Intervention group:
Withhold 2 days prior to surgery
Other names:
-
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
Other names:
-
Drug: Adalimumab
Control group: Schedule surgery 3 weeks after last administered dose Intervention group:
Schedule surgery 1 week after last administered dose
Other names:
-
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.
Other names:
-
Drug: Certolizumab
Control group: Schedule surgery 5 weeks after last administered dose. Intervention group:
Schedule surgery 2 weeks after last administered dose.
Other names:
-
Drug: Infliximab
Control group: Schedule surgery 9 weeks after last administered intravenous dose.
Intervention group: Schedule surgery 4 weeks after last administered dose.
Other names:
-
Biological: Rituximab
Control: Schedule 7 months after last administered dose. Intervention group: Schedule 3
months after last administered dose.
Other names:
-
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.
Other names:
-
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.
Other names:
-
Biological: Anakinra
Control group: Schedule surgery 2 days after last administered daily dose. Experimental
group: Schedule surgery 1 day after last administered daily dose.
Other names:
-
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.
Other names:
-
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.
Other names:
-
Biological: Secukinumab
Control group: Schedule surgery 5 weeks after last administered subcutaneous dose.
Intervention group: Schedule surgery 2 weeks after last administered subcutaneous dose.
Other names:
-
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.
Other names:
-
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
Other names:
-
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.
Other names:
-
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.
Other names:
-
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.
Other names:
-
Drug: Tofacitinib
Control group: Schedule surgery 4 days after last administered daily dose. Intervention
group: Schedule surgery 2 days after last administered daily dose.
Other names:
-
Drug: Upadacitinib
Control group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior
to surgery
Other names:
|
Recruiting Locations
NYU Langone Health
New York,
New York
10016
More Details
- Status
- Recruiting
- Sponsor
- NYU Langone Health
Study Contact
Thomas Chalothron
646-501-7384
Thomas.Chalothron@nyulangone.org
Notice
Study information shown on this site is derived from
ClinicalTrials.gov (a public registry operated by the National Institutes of Health).
The listing of studies provided is not certain to be all studies for which you might be eligible.
Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.