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临床试验/NCT06544343
NCT06544343招募中不适用

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

University Of Perugia2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
190
试验地点
2
主要终点
Treatment persistence

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Treatment persistence

时间窗: 6 months

Percentage of patients taking the same medication prescribed at baseline

次要结局

  • Medical Research Council (MRC) dyspnoea scale(6 months)
  • Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)(6 months)
  • Body Surface Area (BSA)(6 months)
  • Minimal Disease Activity (MDA)(6 months)
  • EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)(6 months)
  • Psoriatic Arthritis Disease Activity Score (PASDAS)(6 months)
  • Modified Rodnan's skin score(6 months)
  • EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)(6 months)
  • Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K(6 months)
  • Anxiety and Depression(6 months)
  • EQ-5D-5L score(6 months)
  • Number of consultations to GP due to prescribed treatment-related issues(6 months)
  • Treatment Persistence(3 months)
  • Ankylosing Spondylitis Disease Activity Score (ASDAS)(6 months)
  • Health Assessment Questionnaire Disability Index (HAQ-DI)(6 months)
  • Number of phone calls to Rheumatology Outpatient Clinic(6 months)
  • Number of additional, unscheduled rheumatology consultations(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Bartoloni Bocci

Associate Professor

University Of Perugia

研究点 (2)

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