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Recruiting NCT06544343

Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy

No phase Interventional Rheumatoid Arthritis Psoriatic Arthritis Systemic Lupus Erythematosus Systemic Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote Monitoring, On site monitoring.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis, Psoriatic Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy in Patients With Rheumatologic Diseases: Comparison With Standard Management

Overview

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.

Interventions

  • Other 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
  • Other On site monitoring
    Follow-up at outpatient clinic at 3 and 6 months from drug prescription.

Primary outcome measures

  • Treatment persistence [Time frame: 6 months]
Secondary outcome measures (12)
  • Treatment Persistence [Time frame: 3 months]
  • Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP) [Time frame: 3 months]
  • Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP) [Time frame: 6 months]
  • Psoriatic Arthritis Disease Activity Score (PASDAS) [Time frame: 3 months]
  • Psoriatic Arthritis Disease Activity Score (PASDAS) [Time frame: 6 months]
  • Body Surface Area (BSA) [Time frame: 3 months]
  • Body Surface Area (BSA) [Time frame: 6 months]
  • Minimal Disease Activity (MDA) [Time frame: 3 months]
  • Minimal Disease Activity (MDA) [Time frame: 6 months]
  • Modified Rodnan's skin score [Time frame: 3 months]
  • Modified Rodnan's skin score [Time frame: 6 months]
  • Medical Research Council (MRC) dyspnoea scale [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Rheumatology Unit - Perugia Univeristy Hospital — Perugia

Identifiers

NCT: NCT06544343 · 4663/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗