Rheumatic Disease
Conditions
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
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.
Interventions
DRUGTofacitinib
Control group: Schedule surgery 4 days after last administered daily dose. Intervention group: Schedule surgery 2 days after last administered daily dose.
DRUGUpadacitinib
Control group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior to surgery
DRUGMethotrexate
Continue throughout perioperative period
DRUGSulfasalazine
Continue throughout perioperative period
DRUGHydroxychloroquine
Continue throughout perioperative period
DRUGLeflunomide
Continue throughout perioperative period
DRUGAzathioprine
Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
DRUGMycophenolate
Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
DRUGCyclosporine
Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
DRUGTacrolimus
Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
DRUGEtanercept
Control group: Schedule surgery 2 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
DRUGAdalimumab
Control group: Schedule surgery 3 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
DRUGGolimumab
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.
DRUGCertolizumab
Control group: Schedule surgery 5 weeks after last administered dose. Intervention group: Schedule surgery 2 weeks after last administered dose.
DRUGInfliximab
Control group: Schedule surgery 9 weeks after last administered intravenous dose. Intervention group: Schedule surgery 4 weeks after last administered dose.
BIOLOGICALRituximab
Control: Schedule 7 months after last administered dose. Intervention group: Schedule 3 months after last administered dose.
BIOLOGICALBelimumab
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.
BIOLOGICALTocilizumab
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.
BIOLOGICALAnakinra
Control group: Schedule surgery 2 days after last administered daily dose. Experimental group: Schedule surgery 1 day after last administered daily dose.
BIOLOGICALCanakinumab
Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.
BIOLOGICALAbatacept
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.
BIOLOGICALSecukinumab
Control group: Schedule surgery 5 weeks after last administered subcutaneous dose. Intervention group: Schedule surgery 2 weeks after last administered subcutaneous dose.
BIOLOGICALIxekizumab
Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.
BIOLOGICALBimekizumab
Control group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4 weeks after last administered 8-week dose
BIOLOGICALUstekinumab
Control group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6 weeks after last administered 12-week dose.
BIOLOGICALGuselkumab
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.
BIOLOGICALRisankizumab
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of wound complications | 90-day post operation |
| Incidence of superficial surgical site infections | 90-day post operation |
| Incidence of deep surgical site infections | 90-day post operation |
| Incidence of return trips to the operating room | 90-day post operation |
| Incidence of rheumatologic disease flares | 90-day post operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS - Physical Function (PF) - Short Form 10a | Week 2, Month 3 | The PROMIS PF-10a asks respondents to rate their ability to perform 10 physical activities. The responses are summed to create a raw score, which ranges from 10 (representing the lowest level of physical function) to 50 (representing the highest level of physical function). |
| Change in PROMIS - Pain Interference - Short Form 6a | Week 2, Month 3 | The questionnaire consists of 6 items assessing pain interference. Participants are asked to rate each item from 1 (not at all) to 5 (very much). The PROMIS Pain Interference - Short Form 6a has a possible raw score range of 6 to 30, where higher scores indicate greater pain interference. This raw score is then converted to a T-score, which has a mean of 50 and a standard deviation of 10 in a reference population. |
| Length of hospital stay | From admission to discharge (on average 2 days) | — |
| Change in Disabilities of the Arm, Shoulder and Hand (DASH) score | Week 2, Month 3 | The DASH is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Scores range from 0 to 100, with 0 indicating no disability and 100 indicating the most severe disability. A higher DASH score reflects greater disability and severity of symptoms. |
| Proportion of participants who used rescue medications or corticosteroid bursts | Month 3 | — |
| Change in American Shoulder and Elbow Surgeons (ASES) score | Week 2, Month 3 | The ASES questionnaire is a patient-reported outcome measure used to assess shoulder function and pain. It includes a pain scale (using a visual analog scale) and a functional subscale assessing activities of daily living. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. |
| Postoperative pain score as assessed by the VAS for Pain | Week 2 | Visual Analogue Scale (VAS) for Pain is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain. |
| Change in Range of motion (ROM) - active forward elevation (AFE) | Week 2, Month 3 | The normal range for AFE is between 170 and 180 degrees. A decrease suggests reduced range of motion. |
| Change in Range of motion (ROM) - external rotation (ER) | Week 2, Month 3 | Normal ER ROM can range from 70 to 90 degrees. A decrease suggests reduced range of motion. |
| Change in Range of motion (ROM) - internal rotation (IR) | Week 2, Month 3 | The normal IR ROM is 70 to 90 degrees. A decrease suggests reduced range of motion. |
Countries
United States
Contacts
Primary ContactThomas Chalothron
Backup ContactLauren Drillock
Outcome results
None listed