Clinical trial NCT06544343: Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy
Official title: Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy in Patients With Rheumatologic Diseases: Comparison With Standard Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Systemic Lupus Erythematosus
Systemic Sclerosis
Spondyloarthritis, Axial
Ankylosing Spondylitis
Keywords: Immunosuppression
Quality of Life
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 190
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Treatment persistence
timeFrame: 6 months
Secondary outcomes:
measure: Treatment Persistence
timeFrame: 3 months
measure: Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)
timeFrame: 3 months
measure: Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)
timeFrame: 6 months
measure: Psoriatic Arthritis Disease Activity Score (PASDAS)
timeFrame: 3 months
measure: Psoriatic Arthritis Disease Activity Score (PASDAS)
timeFrame: 6 months
measure: Body Surface Area (BSA)
timeFrame: 3 months
measure: Body Surface Area (BSA)
timeFrame: 6 months
measure: Minimal Disease Activity (MDA)
timeFrame: 3 months
measure: Minimal Disease Activity (MDA)
timeFrame: 6 months
measure: Modified Rodnan's skin score
timeFrame: 3 months
measure: Modified Rodnan's skin score
timeFrame: 6 months
measure: Medical Research Council (MRC) dyspnoea scale
timeFrame: 3 months
measure: Medical Research Council (MRC) dyspnoea scale
timeFrame: 6 months
measure: EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
timeFrame: 3 months
measure: EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
timeFrame: 6 months
measure: EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
timeFrame: 3 months
measure: EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
timeFrame: 6 months
measure: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
timeFrame: 3 months
measure: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
timeFrame: 6 months
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: 3 months
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: 6 months
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: 3 months
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: 6 months
measure: Anxiety and Depression
timeFrame: 3 months
measure: Anxiety and Depression
timeFrame: 6 months
measure: EQ-5D-5L score
timeFrame: 3 months
measure: EQ-5D-5L score
timeFrame: 6 months
measure: Number of phone calls to Rheumatology Outpatient Clinic
timeFrame: 6 months
measure: Number of additional, unscheduled rheumatology consultations
timeFrame: 6 months
measure: Number of consultations to GP due to prescribed treatment-related issues
timeFrame: 6 months
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Rheumatology Unit - Perugia Univeristy Hospital
state: PG
Study officials:
References: