Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy

Not Applicable

Recruiting

• Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis; Systemic Sclerosis; Psoriatic Arthritis; Systemic Lupus Erythematosus; Spondyloarthritis, Axial
• Interventions: Other: Remote Monitoring; Other: On site monitoring

• Registration Number: NCT06544343
• Lead Sponsor: University Of Perugia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Study First Submitted: 2024-07-19
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-03-18
• Study Completion: 2026-03-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Monitoring	Remote Monitoring	-
Remote Monitoring	On site monitoring	-
On site only	On site monitoring	-

Primary Outcome Measures

Name	Time	Method
Treatment persistence	6 months	Percentage of patients taking the same medication prescribed at baseline

Secondary Outcome Measures

Name	Time	Method
Medical Research Council (MRC) dyspnoea scale	6 months	Only applies to systemic sclerosis patients with interstitial lung disease
Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)	6 months	Only applies to rheumatoid arthritis patients
Body Surface Area (BSA)	6 months	Percentage of skin surface with psoriatic lesions. Only applies to psoriatic arthritis patients
Minimal Disease Activity (MDA)	6 months	Binary outcome. Only applies to psoriatic arthritis patients
Psoriatic Arthritis Disease Activity Score (PASDAS)	6 months	Only applies to psoriatic arthritis patients
Modified Rodnan's skin score	6 months	Only applies to systemic sclerosis patients
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)	6 months	Only applies to Sjogren's disease patients
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K	6 months	Only applies to systemic lupus erythematosus patients
Anxiety and Depression	6 months	Hospital Anxiety and Depression Scale - Anxiety and Depression range 0 - 21 each (higher values mean higher degrees of depression or anxiety)
EQ-5D-5L score	6 months	The score measures quality of life and includes 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which is scored from 1 (perfect health) to 5 (complete inability).
Number of consultations to GP due to prescribed treatment-related issues	6 months
Treatment Persistence	3 months	Percentage of patients taking the same medication prescribed at baseline
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)	6 months	Only applies to Sjogren's disease patients
Ankylosing Spondylitis Disease Activity Score (ASDAS)	6 months	Only applies to ankylosing spondylitis and axial spondyloarthritis patients
Health Assessment Questionnaire Disability Index (HAQ-DI)	6 months	Range 0 (best condition) - 3 (worst condition)
Number of phone calls to Rheumatology Outpatient Clinic	6 months
Number of additional, unscheduled rheumatology consultations	6 months

Trial Locations

Locations (1)

Rheumatology Unit - Perugia Univeristy Hospital; 🇮🇹 Perugia, PG, Italy