Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy (TEMPLATE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Systemic Lupus Erythematosus; Systemic Sclerosis; Psoriatic Arthritis; Ankylosing Spondylitis; Spondyloarthritis, Axial
• Intervention / Treatment: Other: Remote Monitoring; Other: On site monitoring

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PG
    • Perugia, PG, Italy, 06129
      • Recruiting
      • Rheumatology Unit - Perugia Univeristy Hospital
      • Contact: Elena Bartoloni, MD; Phone Number: +39 0755783975; Email: elena.bartolonibocci@unipg.it
      • Contact: Giacomo Cafaro, MD PhD; Phone Number: +39 0755783975; Email: giacomo.cafaro@unipg.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Monitoring	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.
Placebo Comparator: On site only	Other: On site monitoring; Follow-up at outpatient clinic at 3 and 6 months from drug prescription.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment persistence	Percentage of patients taking the same medication prescribed at baseline	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Of Perugia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): March 18, 2026
• Study Completion (Estimated): March 18, 2026

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Immunosuppression; Quality of Life
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Psoriasis; Bone Diseases, Infectious; Ankylosis; Arthritis; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Arthritis, Psoriatic; Spondylitis; Spondylitis, Ankylosing; Axial Spondyloarthritis
• Other Study ID Numbers: 4663/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No