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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT07138898
- Acronym / sponsor ID
- 25-00380
- Conditions
- Rheumatic Disease
- Keywords
- rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, juvenile idiopathic arthritis, spondyloarthritis, polymyalgia rheumatica, giant cell arteritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard hold | Active comparator | 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: UpadacitinibPatients 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. |
| Shorter hold | Experimental | 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: UpadacitinibPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateContinue throughout perioperative period | Drug | Shorter hold, Standard hold |
| SulfasalazineContinue throughout perioperative period | Drug | Shorter hold, Standard hold |
| HydroxychloroquineAlso: PlaquenilContinue throughout perioperative period | Drug | Shorter hold, Standard hold |
| LeflunomideAlso: AravaContinue throughout perioperative period | Drug | Shorter hold, Standard hold |
| AzathioprineAlso: ImuranControl group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery | Drug | Shorter hold, Standard hold |
| MycophenolateAlso: CellceptControl group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery | Drug | Shorter hold, Standard hold |
| CyclosporineControl group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery | Drug | Shorter hold, Standard hold |
| TacrolimusControl group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery | Drug | Shorter hold, Standard hold |
| EtanerceptAlso: EnbrelControl group: Schedule surgery 2 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose | Drug | Shorter hold, Standard hold |
| AdalimumabAlso: HumiraControl group: Schedule surgery 3 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose | Drug | Shorter hold, Standard hold |
| GolimumabAlso: SimponiControl 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. | Drug | Shorter hold, Standard hold |
| CertolizumabAlso: CimziaControl group: Schedule surgery 5 weeks after last administered dose. Intervention group: Schedule surgery 2 weeks after last administered dose. | Drug | Shorter hold, Standard hold |
| InfliximabAlso: RemicaideControl group: Schedule surgery 9 weeks after last administered intravenous dose. Intervention group: Schedule surgery 4 weeks after last administered dose. | Drug | Shorter hold, Standard hold |
| RituximabAlso: RituxanControl: Schedule 7 months after last administered dose. Intervention group: Schedule 3 months after last administered dose. | Biological | Shorter hold, Standard hold |
| BelimumabAlso: BenlystaControl 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. | Biological | Shorter hold, Standard hold |
| TocilizumabAlso: ActemraControl 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. | Biological | Shorter hold, Standard hold |
| AnakinraAlso: KineretControl group: Schedule surgery 2 days after last administered daily dose. Experimental group: Schedule surgery 1 day after last administered daily dose. | Biological | Shorter hold, Standard hold |
| CanakinumabAlso: IlarisControl group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose. | Biological | Shorter hold, Standard hold |
| AbataceptAlso: OrenciaControl 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. | Biological | Shorter hold, Standard hold |
| SecukinumabAlso: CosentyxControl group: Schedule surgery 5 weeks after last administered subcutaneous dose. Intervention group: Schedule surgery 2 weeks after last administered subcutaneous dose. | Biological | Shorter hold, Standard hold |
| IxekizumabAlso: TaltzControl group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose. | Biological | Shorter hold, Standard hold |
| BimekizumabAlso: BimzelxControl group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4 weeks after last administered 8-week dose | Biological | Shorter hold, Standard hold |
| UstekinumabAlso: StelaraControl group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6 weeks after last administered 12-week dose. | Biological | Shorter hold, Standard hold |
| GuselkumabAlso: TremfyaControl group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4.5 weeks after last administered 8-week dose. | Biological | Shorter hold, Standard hold |
| RisankizumabAlso: SkyriziControl group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6-7 weeks after last administered 12-week dose. | Biological | Shorter hold, Standard hold |
| TofacitinibAlso: XeljanzControl group: Schedule surgery 4 days after last administered daily dose. Intervention group: Schedule surgery 2 days after last administered daily dose. | Drug | Shorter hold, Standard hold |
| UpadacitinibAlso: RinvoqControl group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior to surgery | Drug | Shorter hold, Standard hold |
Primary outcome
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
12 secondary outcomes
Length of hospital stay
Time frame: From admission to discharge (on average 2 days)
Postoperative pain score as assessed by the VAS for Pain
Time frame: Week 2
Postoperative pain score as assessed by the VAS for Pain
Time frame: Week 6
Postoperative pain score as assessed by the VAS for Pain
Time frame: Month 3
Change in Range of motion (ROM) - active forward elevation (AFE)
Time frame: Week 2, Month 3
Change in Range of motion (ROM) - external rotation (ER)
Time frame: Week 2, Month 3
Change in Range of motion (ROM) - internal rotation (IR)
Time frame: Week 2, Month 3
Change in PROMIS - Physical Function (PF) - Short Form 10a
Time frame: Week 2, Month 3
Change in PROMIS - Pain Interference - Short Form 6a
Time frame: Week 2, Month 3
Change in American Shoulder and Elbow Surgeons (ASES) score
Time frame: Week 2, Month 3
Change in Disabilities of the Arm, Shoulder and Hand (DASH) score
Time frame: Week 2, Month 3
Proportion of participants who used rescue medications or corticosteroid bursts
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Samuels, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Chalothron (646-501-7384, Thomas.Chalothron@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of wound complications (time frame: 90-day post operation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.