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New treatment option for Rheumatic Disease
Official title Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
ClinicalTrials.gov ID: NCT07138898
What this study is testing
What is Methotrexate?
Methotrexate is an investigational medicine, being studied as a potential treatment for rheumatic disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Unable or without capacity to provide written informed consent prior to any study specific procedures.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.