Actively Recruiting

Phase Not Applicable
All Genders
NCT06544343

Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy

Led by University Of Perugia · Updated on 2024-08-09

190

Participants Needed

1

Research Sites

89 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, Spondyloarthritis, Ankylosing Spondylitis, Systemic Sclerosis, Systemic Lupus Erythematosus, or Sjogren's Disease
  • Prescribed a new immunosuppressive medication from 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, or Anifrolumab
Not Eligible

You will not qualify if you...

  • Treatment with a medication not approved for the condition
  • Inability to use a device for remote calls, even with caregiver assistance

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Rheumatology Unit - Perugia Univeristy Hospital

Perugia, PG, Italy, 06129

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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