About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Rheumatoid Arthritis
Psoriatic Arthritis
Spondyloarthritis
Ankylosing Spondylitis
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Remote Monitoring
Other interventionFollow-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
Other interventionFollow-up at outpatient clinic at 3 and 6 months from drug prescription.
Treatment groups
Trial outcomes
Primary outcomes
Treatment persistence
Percentage of patients taking the same medication prescribed at baseline
Secondary outcomes
Treatment Persistence
Percentage of patients taking the same medication prescribed at baseline
Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)
Only applies to rheumatoid arthritis patients
Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)
Only applies to rheumatoid arthritis patients
Psoriatic Arthritis Disease Activity Score (PASDAS)
Only applies to psoriatic arthritis patients
Sponsors and contacts
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