A Phase 2 interventional study of Methotrexate and Sulfasalazine in Rheumatic Disease, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by NYU Langone Health · Phase 2, Interventional, and Treatment
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.
264 studies on the registry are indexed under Rheumatic Diseases; 60 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 167 interventional studies indexed under Rheumatic Diseases.
Browse Rheumatic Diseases studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · 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
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 · 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
Continue throughout perioperative period
Continue throughout perioperative period
Continue throughout perioperative period
Also known as: Plaquenil
Continue throughout perioperative period
Also known as: Arava
Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
Also known as: Imuran
Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
Also known as: Cellcept
Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
Control group: Schedule surgery 2 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
Also known as: Enbrel
Control group: Schedule surgery 3 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
Also known as: Humira
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.
Also known as: Simponi
Control group: Schedule surgery 5 weeks after last administered dose. Intervention group: Schedule surgery 2 weeks after last administered dose.
Also known as: Cimzia
Control group: Schedule surgery 9 weeks after last administered intravenous dose. Intervention group: Schedule surgery 4 weeks after last administered dose.
Also known as: Remicaide
Control: Schedule 7 months after last administered dose. Intervention group: Schedule 3 months after last administered dose.
Also known as: Rituxan
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.
Also known as: 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.
Also known as: Actemra
Control group: Schedule surgery 2 days after last administered daily dose. Experimental group: Schedule surgery 1 day after last administered daily dose.
Also known as: Kineret
Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.
Also known as: Ilaris
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.
Also known as: Orencia
Control group: Schedule surgery 5 weeks after last administered subcutaneous dose. Intervention group: Schedule surgery 2 weeks after last administered subcutaneous dose.
Also known as: Cosentyx
Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.
Also known as: Taltz
Control group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4 weeks after last administered 8-week dose
Also known as: Bimzelx
Control group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6 weeks after last administered 12-week dose.
Also known as: Stelara
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.
Also known as: Tremfya
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.
Also known as: Skyrizi
Control group: Schedule surgery 4 days after last administered daily dose. Intervention group: Schedule surgery 2 days after last administered daily dose.
Also known as: Xeljanz
Control group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior to surgery
Also known as: Rinvoq
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
Length of hospital stay
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 2, Month 3
Proportion of participants who used rescue medications or corticosteroid bursts
Time frame: Month 3
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to jonathan.samuels@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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Started Dec 2025 (actual). Primary completion is estimated for Jan 2028, 25 months after the start.
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Studies of the drugs tested here: Methotrexate · Sulfasalazine · Hydroxychloroquine · Leflunomide · Azathioprine · Mycophenolic Acid · Cyclosporine · Tacrolimus · Etanercept · Adalimumab · Golimumab · Certolizumab Pegol · Infliximab · Rituximab · Belimumab · Tocilizumab · Interleukin 1 Receptor Antagonist Protein · Canakinumab · Abatacept · Secukinumab · Ixekizumab · Bimekizumab · Ustekinumab · Guselkumab · Risankizumab · Tofacitinib · Upadacitinib