Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy
NCT ID: NCT06544343
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
190 participants
INTERVENTIONAL
2024-07-01
2026-03-18
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Remote Monitoring
Remote Monitoring
Follow-up at outpatient clinic at 3 and 6 months from drug prescription Two remote consultations at 15 and 45 days from drug prescription
On site monitoring
Follow-up at outpatient clinic at 3 and 6 months from drug prescription.
On site only
On site monitoring
Follow-up at outpatient clinic at 3 and 6 months from drug prescription.
Interventions
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Remote Monitoring
Follow-up at outpatient clinic at 3 and 6 months from drug prescription Two remote consultations at 15 and 45 days from drug prescription
On site monitoring
Follow-up at outpatient clinic at 3 and 6 months from drug prescription.
Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to use a device for remote call, not even with the help of a caregiver
ALL
No
Sponsors
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University Of Perugia
OTHER
Responsible Party
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Elena Bartoloni Bocci
Associate Professor
Locations
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Rheumatology Unit - Perugia Univeristy Hospital
Perugia, PG, Italy
Countries
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Facility Contacts
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Other Identifiers
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4663/24
Identifier Type: -
Identifier Source: org_study_id
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