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临床试验/NCT07726355
NCT07726355已完成2 期

A Randomized Clinical Trial Evaluating the Efficacy of Clinical Pharmacist Assistance Along With Pharmaceutical and Non-pharmaceutical Therapy in the Early Rheumatoid Arthritis

Deraya University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月10日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
70
试验地点
1
主要终点
Disease activity

研究概览

简要总结

Background: Rheumatoid arthritis (RA) is a progressive chronic autoimmune disease with a rising global burden, in which early diagnosis and timely therapeutic intervention are critical to preventing irreversible joint damage and preserving long-term function. Despite established treat-to-target (T2T) frameworks-incorporating conventional, biological, and targeted synthetic disease-modifying antirheumatic drugs (DMARDs) and endorsed by the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology (ACR)-a substantial proportion of patients with early RA fail to achieve the recommended target of DAS28 <2.6 (remission) or 2.6-3.2 (low disease activity), reflecting persistent gaps in disease management. Pharmacological therapy alone is insufficient: adherence barriers, inadequate disease knowledge, psychosocial distress, unresolved medication-related problems, and suboptimal monitoring continue to undermine outcomes. Clinical pharmacists, whose scope of practice has expanded substantially beyond dispensing to encompass medication optimization, patient education, and behavioral support, represent an underutilized resource in rheumatology care.

Purpose: This narrative review synthesizes available evidence on the impact of clinical pharmacist-led interventions on disease activity (DAS28), medication adherence, functional disability, and quality of life (QoL) outcomes in patients with early RA, with particular attention to non-pharmacological mechanisms of effect and the role of adherence as a core mediating outcome.

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

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18-65 years.
  • Diagnosis of early RA according to the 2010 ACR/EULAR classification criteria.
  • Disease lasts less than 2 years.
  • Presence of at least one tender and one swollen joint.
  • Ability to provide informed consent.

排除标准

  • Use of oral glucocorticoids >10 mg/day during the previous 3 weeks.
  • Current biological DMARD therapy.
  • AST or ALT >3 times the upper limit of normal.
  • eGFR <30 mL/min/1.73 m².
  • Active infection.
  • Malignancy.
  • Pregnancy or lactation.
  • Other autoimmune or musculoskeletal disorders.
  • Inability to participate in follow-up.

结局指标

主要结局

Disease activity

时间窗: 6 months

Measured using the Disease Activity Score in 28 joints (DAS28-ESR

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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