Not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.
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IBD (general)Recruiting

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Phase 2 · Testing Methotrexate, Sulfasalazine and Hydroxychloroquine · 1 site · NYU Langone Health

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Methotrexate (a drug), Sulfasalazine (a drug), Hydroxychloroquine (a drug) and Leflunomide (a drug) as a possible treatment. Condition(s) listed: Rheumatic Disease.

Participants are assigned to groups by chance (randomized).

It is single-blind: participants do not know which group they are in.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

Some of the main requirements, copied from the record:

Plus 2 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

Main thing being measured

In the researchers’ words

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…

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Official details

StatusRecruiting
PhasePhase 2
Study typeInterventional
ConditionsRheumatic Disease
Lead sponsorNYU Langone Health
Enrollment80 (estimated)
Start date2025-12-12
Primary completion (est.)2028-01
First posted2025-08-24
Last updated2026-07-09
Official titleImmunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
ClinicalTrials.gov IDNCT07138898

Interventions

Full eligibility criteria (from the record)
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.

Locations (1)

SiteCityCountrySite status
NYU Langone HealthNew York, New YorkUnited StatesRecruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.