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NCT Number: NCT06544343

Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy

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.

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Key information

Conditions

Rheumatoid Arthritis Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Rheumatic Diseases Scleroderma, Systemic Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Spondyloarthritis, Axial Systemic Lupus Erythematosus Systemic Sclerosis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote monitoring

Other

Follow-up at outpatient clinic at 3 and 6 months from drug prescription Two remote consultations at 15 and 45 days from drug prescription

On site monitoring

Other

Follow-up at outpatient clinic at 3 and 6 months from drug prescription.

Primary outcomes

  1. Treatment persistence

    Time frame: 6 months

    Percentage of patients taking the same medication prescribed at baseline

Secondary outcomes

  1. Treatment Persistence

    Time frame: 3 months

    Percentage of patients taking the same medication prescribed at baseline

  2. Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)

    Time frame: 3 months

    Only applies to rheumatoid arthritis patients

  3. Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)

    Time frame: 6 months

    Only applies to rheumatoid arthritis patients

  4. Psoriatic Arthritis Disease Activity Score (PASDAS)

    Time frame: 3 months

    Only applies to psoriatic arthritis patients

  5. Psoriatic Arthritis Disease Activity Score (PASDAS)

    Time frame: 6 months

    Only applies to psoriatic arthritis patients

  6. Body Surface Area (BSA)

    Time frame: 3 months

    Percentage of skin surface with psoriatic lesions. Only applies to psoriatic arthritis patients

  7. Body Surface Area (BSA)

    Time frame: 6 months

    Percentage of skin surface with psoriatic lesions. Only applies to psoriatic arthritis patients

  8. Minimal Disease Activity (MDA)

    Time frame: 3 months

    Binary outcome. Only applies to psoriatic arthritis patients

  9. Minimal Disease Activity (MDA)

    Time frame: 6 months

    Binary outcome. Only applies to psoriatic arthritis patients

  10. Modified Rodnan's skin score

    Time frame: 3 months

    Only applies to systemic sclerosis patients

  11. Modified Rodnan's skin score

    Time frame: 6 months

    Only applies to systemic sclerosis patients

  12. Medical Research Council (MRC) dyspnoea scale

    Time frame: 3 months

    Only applies to systemic sclerosis patients with interstitial lung disease

  13. Medical Research Council (MRC) dyspnoea scale

    Time frame: 6 months

    Only applies to systemic sclerosis patients with interstitial lung disease

  14. EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

    Time frame: 3 months

    Only applies to Sjogren's disease patients

  15. EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

    Time frame: 6 months

    Only applies to Sjogren's disease patients

  16. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)

    Time frame: 3 months

    Only applies to Sjogren's disease patients

  17. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)

    Time frame: 6 months

    Only applies to Sjogren's disease patients

  18. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K

    Time frame: 3 months

    Only applies to systemic lupus erythematosus patients

  19. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K

    Time frame: 6 months

    Only applies to systemic lupus erythematosus patients

  20. Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Time frame: 3 months

    Only applies to ankylosing spondylitis and axial spondyloarthritis patients

  21. Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Time frame: 6 months

    Only applies to ankylosing spondylitis and axial spondyloarthritis patients

  22. Health Assessment Questionnaire Disability Index (HAQ-DI)

    Time frame: 3 months

    Range 0 (best condition) - 3 (worst condition)

  23. Health Assessment Questionnaire Disability Index (HAQ-DI)

    Time frame: 6 months

    Range 0 (best condition) - 3 (worst condition)

  24. Anxiety and Depression

    Time frame: 3 months

    Hospital Anxiety and Depression Scale - Anxiety and Depression range 0 - 21 each (higher values mean higher degrees of depression or anxiety)

  25. Anxiety and Depression

    Time frame: 6 months

    Hospital Anxiety and Depression Scale - Anxiety and Depression range 0 - 21 each (higher values mean higher degrees of depression or anxiety)

  26. EQ-5D-5L score

    Time frame: 3 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).

  27. EQ-5D-5L score

    Time frame: 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).

  28. Number of phone calls to Rheumatology Outpatient Clinic

    Time frame: 6 months

  29. Number of additional, unscheduled rheumatology consultations

    Time frame: 6 months

  30. Number of consultations to GP due to prescribed treatment-related issues

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Of Perugia

Other

Registry information

Official study title

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

Acronym: TEMPLATE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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