Immunosuppressant Management for Rheumatic Diseases
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how varying the duration of stopping immunosuppressants before shoulder replacement surgery affects individuals with rheumatic diseases such as rheumatoid arthritis or lupus. It compares the usual stop period with a shorter one to determine which leads to fewer flares, less pain, and fewer complications. Individuals who have taken immunosuppressants for at least three months and are planning a shoulder replacement may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial involves stopping immunosuppressant medications for a certain period before surgery, but the exact duration is not specified. If you have severe SLE, you will need to stay on your current treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that many drugs used in this trial are generally well-tolerated. For example, studies on Abatacept report a 6.7% complication rate after surgery in patients with rheumatoid arthritis, which is relatively low. Anakinra is also considered well-tolerated, with mostly mild reactions at injection sites.
Adalimumab has mixed safety data. Some studies suggest it may increase the risk of infections after surgery, while others show different results. Belimumab has not shown any new safety concerns over five years of use in certain conditions.
Certolizumab commonly causes side effects like respiratory infections and rashes. Similarly, Cyclosporine is considered safe for patients with rheumatoid arthritis who don't respond to standard treatments.
Hydroxychloroquine is known for its good safety record, with no increased risk of infection. Infliximab, when given within four weeks of surgery, does not show a higher risk of serious infections.
Methotrexate has not been linked to an increase in complications after surgery, and Tocilizumab has a low rate of surgical complications at 8.6%.
Overall, these treatments are generally safe, although some, like Adalimumab and Rituximab, may carry a risk of infection. Always discuss potential risks with a healthcare provider before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores new ways to manage immunosuppressant use in patients undergoing surgery for rheumatic diseases. Unlike the standard protocol, which requires patients to stop their medication for a longer period before surgery, the experimental approach aims to shorten this hold based on each drug's pharmacokinetics. This could potentially minimize the risk of disease flare-ups while still maintaining safety around surgery. If successful, this trial could lead to a more personalized and effective management strategy for patients, reducing complications and improving recovery times.
What evidence suggests that this trial's treatments could be effective for rheumatic diseases?
This trial will compare two different immunosuppressant management protocols for rheumatic diseases. Research has shown that many treatments in this study effectively manage rheumatic diseases. For example, abatacept reduces inflammation and symptoms in people with rheumatoid arthritis over time. Adalimumab has delivered excellent results in treating rheumatoid arthritis, with many patients responding well. Anakinra also reduces symptoms, though some studies suggest it might not be as strong as adalimumab. Azathioprine manages rheumatoid arthritis by calming the immune system. Belimumab has significantly improved patients with systemic lupus erythematosus, a condition related to rheumatic diseases. Overall, strong clinical evidence supports these medications' effectiveness in treating various rheumatic diseases.678910
Who Is on the Research Team?
Jonathan Samuels, MD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for patients with rheumatic diseases like Rheumatoid Arthritis or Lupus, who are planning to undergo elective shoulder replacement surgery. Participants should be on immunosuppressants and willing to adjust their medication timing before surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Immunosuppressant Hold
Participants follow either a standard or shorter immunosuppressant hold protocol before surgery
Surgery and Immediate Postoperative
Participants undergo shoulder arthroplasty and medications are restarted postoperatively
Follow-up
Participants are monitored for safety, effectiveness, and changes in pain and functional outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Abatacept
- Adalimumab
- Anakinra
- Azathioprine
- Belimumab
- Bimekizumab
- Canakinumab
- Certolizumab
- Cyclosporine
- Etanercept
- Golimumab
- Guselkumab
- Hydroxychloroquine
- Infliximab
- Ixekizumab
- Leflunomide
- Methotrexate
- Mycophenolate
- Risankizumab
- Rituximab
- Secukinumab
- Sulfasalazine
- Tacrolimus
- Tocilizumab
- Tofacitinib
- Upadacitinib
- Ustekinumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor