Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test on Clinical Outcomes and Pharmaceutical Utilization in Patients With Rheumatoid Arthritis: A Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 444
- 试验地点
- 10
- 主要终点
- Mean MBDA Score
研究概览
简要总结
Nine months multi-center prospective, randomized observational study, two arm trial to evaluate the effect of MBDA score-guided care on disease activity and medical costs.
详细描述
Nine months multi-center prospective, randomized observational study, two arm trial to evaluate the effect of MBDA score-guided care on disease activity and medical costs. To investigate whether treatment decisions guided by MBDA scores result in reduced disease activity and overall medical cost among patients with RA relative to usual care (UC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to sign an informed consent form (ICF)
- •Age at least 18 years old at screening visit
- •Diagnosed with RA according to 1987 or 2010 criteria of the American College of Rheumatology
- •Actively managed by a CareFirst health care practitioner
- •Currently taking one or more biologic and/or non-biologic DMARDs listed in Appendix 2
- •Currently has CareFirst medical coverage
排除标准
- •Active infection
- •History of malignancy within the past 5 years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ that has been treated or excised in a curative procedure
- •Current enrollment in another clinical trial
- •On non-biologic DMARD monotherapy or combination therapy with stable disease for ≥6 months
- •Any condition or circumstance that makes it likely the patient will not be able to complete the 9-month trial
结局指标
主要结局
Mean MBDA Score
时间窗: Baseline to 9 months
Change in disease activity from baseline to month 9 as measured by mean MBDA score. MBDA Score stands for the Vectra multi-biomarker disease activity (MBDA) blood test. Scale: Low (\>30); Moderate (30-44); High (\>44)
次要结局
- Proportion of Patients who Showed a Response to Medication(Baseline to month 9)
- Treatment Adherence(Baseline to 1 year)
- Medical Utilization(Baseline to 1 year)
- Changes in Overall Medical Costs(Baseline to 1 year)
- Pharmacy Utilization(Baseline to 1 year)