Rheumatic DiseasePhase 2NCT07138898
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
A Phase 2 study testing Methotrexate, Sulfasalazine and Hydroxychloroquine in people with Rheumatic Disease, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Disease
- What is being tested?
- Methotrexate, Sulfasalazine and Hydroxychloroquine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2025to Jan 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older at the time of informed consent;
- 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;
- On active immunosuppression for at least 3 months prior to scheduled surgery;
- Scheduled for elective total shoulder arthroplasty;
- Able and willing to provide written informed consent prior to any study specific procedures.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
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
- Being tested
- Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide, Azathioprine
- 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
- Medical subject headings
- Rheumatic Diseases, Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing, Lupus Erythematosus, Systemic, Arthritis, Juvenile, Spondylarthritis, Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Continue throughout perioperative period
SulfasalazineDrug
Continue throughout perioperative period
Also called Plaquenil
Continue throughout perioperative period
LeflunomideDrug
Also called Arava
Continue throughout perioperative period
AzathioprineDrug
Also called Imuran
Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
MycophenolateDrug
Also called Cellcept
Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
CyclosporineDrug
Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
TacrolimusDrug
Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
EtanerceptDrug
Also called Enbrel
Control group: Schedule surgery 2 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
AdalimumabDrug
Also called Humira
Control group: Schedule surgery 3 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
GolimumabDrug
Also called Simponi
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.
CertolizumabDrug
Also called Cimzia
Control group: Schedule surgery 5 weeks after last administered dose. Intervention group: Schedule surgery 2 weeks after last administered dose.
InfliximabDrug
Also called Remicaide
Control group: Schedule surgery 9 weeks after last administered intravenous dose.
Intervention group: Schedule surgery 4 weeks after last administered dose.
RituximabBiological
Also called Rituxan
Control: Schedule 7 months after last administered dose. Intervention group: Schedule 3 months after last administered dose.
BelimumabBiological
Also called Benlysta
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.
TocilizumabBiological
Also called Actemra
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.
AnakinraBiological
Also called Kineret
Control group: Schedule surgery 2 days after last administered daily dose. Experimental group: Schedule surgery 1 day after last administered daily dose.
CanakinumabBiological
Also called Ilaris
Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.
AbataceptBiological
Also called Orencia
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.
SecukinumabBiological
Also called Cosentyx
Control group: Schedule surgery 5 weeks after last administered subcutaneous dose.
Intervention group: Schedule surgery 2 weeks after last administered subcutaneous dose.
IxekizumabBiological
Also called Taltz
Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.
BimekizumabBiological
Also called Bimzelx
Control group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4 weeks after last administered 8-week dose
UstekinumabBiological
Also called Stelara
Control group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6 weeks after last administered 12-week dose.
GuselkumabBiological
Also called Tremfya
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.
RisankizumabBiological
Also called Skyrizi
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.
TofacitinibDrug
Also called Xeljanz
Control group: Schedule surgery 4 days after last administered daily dose. Intervention group: Schedule surgery 2 days after last administered daily dose.
UpadacitinibDrug
Also called Rinvoq
Control group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard hold | Active comparator | 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. Receives: Drug: Methotrexate; Drug: Sulfasalazine; Drug: Hydroxychloroquine; Drug: Leflunomide; Drug: Azathioprine; Drug: Mycophenolate; Drug: Cyclosporine; Drug: Tacrolimus; Drug: Etanercept; Drug: Adalimumab; Drug: Golimumab; Drug: Certolizumab; Drug: Infliximab; Biological: Rituximab; Biological: Belimumab; Biological: Tocilizumab; Biological: Anakinra; Biological: Canakinumab; Biological: Abatacept; Biological: Secukinumab; Biological: Ixekizumab; Biological: Bimekizumab; Biological: Ustekinumab; Biological: Guselkumab; Biological: Risankizumab; Drug: Tofacitinib; Drug: Upadacitinib |
| Shorter hold | Experimental | 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 Receives: Drug: Methotrexate; Drug: Sulfasalazine; Drug: Hydroxychloroquine; Drug: Leflunomide; Drug: Azathioprine; Drug: Mycophenolate; Drug: Cyclosporine; Drug: Tacrolimus; Drug: Etanercept; Drug: Adalimumab; Drug: Golimumab; Drug: Certolizumab; Drug: Infliximab; Biological: Rituximab; Biological: Belimumab; Biological: Tocilizumab; Biological: Anakinra; Biological: Canakinumab; Biological: Abatacept; Biological: Secukinumab; Biological: Ixekizumab; Biological: Bimekizumab; Biological: Ustekinumab; Biological: Guselkumab; Biological: Risankizumab; Drug: Tofacitinib; Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of wound complications
Measured: 90-day post operation
Incidence of superficial surgical site infections
Measured: 90-day post operation
Incidence of deep surgical site infections
Measured: 90-day post operation
Incidence of return trips to the operating room
Measured: 90-day post operation
Incidence of rheumatologic disease flares
Measured: 90-day post operation
Secondary outcomes (12)
Length of hospital stay
Measured: From admission to discharge (on average 2 days)
Postoperative pain score as assessed by the VAS for Pain
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.
Measured: Week 2
Postoperative pain score as assessed by the VAS for Pain
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.
Measured: Week 6
Postoperative pain score as assessed by the VAS for Pain
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.
Measured: Month 3
Change in Range of motion (ROM) - active forward elevation (AFE)
The normal range for AFE is between 170 and 180 degrees. A decrease suggests reduced range of motion.
Measured: Week 2, Month 3
Change in Range of motion (ROM) - external rotation (ER)
Normal ER ROM can range from 70 to 90 degrees. A decrease suggests reduced range of motion.
Measured: Week 2, Month 3
Change in Range of motion (ROM) - internal rotation (IR)
The normal IR ROM is 70 to 90 degrees. A decrease suggests reduced range of motion.
Measured: Week 2, Month 3
Change in PROMIS - Physical Function (PF) - Short Form 10a
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).
Measured: Week 2, Month 3
Change in PROMIS - Pain Interference - Short Form 6a
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.
Measured: Week 2, Month 3
Change in American Shoulder and Elbow Surgeons (ASES) score
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.
Measured: Week 2, Month 3
Change in Disabilities of the Arm, Shoulder and Hand (DASH) score
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.
Measured: Week 2, Month 3
Proportion of participants who used rescue medications or corticosteroid bursts
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start12 Dec 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Samuels, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138898
- Sponsor's protocol ID
- 25-00380
- Status last verified
- Jul 2026
- First submitted
- 18 Aug 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: jonathan.samuels@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.