Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy (NCT06544343) | Clinical Trial Compass
RecruitingNot Applicable
Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy
Italy190 participantsStarted 2024-07-01
Plain-language summary
Systemic autoimmune and chronic inflammatory diseases are a group of chronic illnesses whose treatment is usually very prolonged, often lifelong, and is essential to keep the disease under control, thus reducing the risk of complications and allowing the best possible quality of life for patients.
The drugs used for treating these diseases are mostly immunosuppressants, which reduce the activity of the immune system, whose alteration is responsible for the disease. Although all available drugs are effective for treating these diseases, for reasons largely unknown, each drug is effective only in a percentage of patients. As a result, it is often necessary to try several different treatments before identifying an effective one for the individual patient.
The therapeutic effects are often slow, and it is therefore necessary to take a treatment for weeks or months before its effectiveness can be determined. The initial period is also when side effects most often appear. The aim of this study is to evaluate whether the addition of remote monitoring visits and other patient support services to traditional periodic medical visits in the first months after the introduction of a new treatment leads to an improvement in adherence, response, and quality of life for the patient.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Any patient with one of the following conditions
* Rheumatoid Arthritis
* Psoriatic Arthritis
* Spondyloarthritis
* Ankylosing Spondylitis
* Systemic Sclerosis
* Systemic Lupus Erythematosus
* Sjogren's Disease who are prescribed a new immunosuppressive medication for the treatment of their disease among the following:
* Methotrexate
* Sulfasalazine
* Leflunomide
* Mycophenolate Mofetil
* Azathioprine
* Cyclosporine A
* Tacrolimus
* TNF inhibitors (etanercept, adalimumab, golimumab, certolizumab pegol)
* IL6 inhibitors (tocilizumab)
* IL-17 inhibitors (secukinumab, ixekizumab)
* IL-23 inhibitors (ustekinumab, guselkumab, risankizumab)
* JAK-inhibitors (tofacitinib, baricitinib, upadacitinib, filgotinib)
* Belimumab
* Anifrolumab
Exclusion Criteria:
* Treatment with a medication not approved for the condition
* Inability to use a device for remote call, not even with the help of a caregiver
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.