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

University Of Perugia

Status: Enrolling

Conditions: Spondyloarthritis, Axial; Systemic Sclerosis; Psoriatic Arthritis; Ankylosing Spondylitis; Systemic Lupus Erythematosus; Rheumatoid Arthritis

Treatments: Other: On site monitoring; Other: Remote Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06544343

4663/24

Details and patient eligibility

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.

Enrollment: 190 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups, including a placebo group

Remote Monitoring

Experimental group

Treatment:

Other: Remote Monitoring

Other: On site monitoring

On site only

Placebo Comparator group

Treatment:

Other: On site monitoring