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临床试验/NCT02897817
NCT02897817已完成不适用

Treatment Adherence in Patients With Rheumatoid Arthritis Previously Treated With Oral or Injectable Methotrexate and Requiring a New Treatment With Injectable Methotrexate

Nordic Pharma SAS1 个研究点 分布在 1 个国家目标入组 471 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
471
试验地点
1
主要终点
Rate of patients whose adherence to methotrexate (MTX) remained strong or improved between inclusion (V0) and follow-up (V1) at 6 months.

研究概览

简要总结

The aim of this study is to evaluate, at 6 months, the rate of patients whose adherence to injectable MTX remained strong or improved according to patient-reported outcome.

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

入选标准

  • Adult patients (≥ 18 years old)
  • Patients with a diagnosis of RA as confirmed by the ACR/EULAR (2010) Classification Criteria for Rheumatoid Arthritis
  • Patients:
  • currently treated with oral MTX and requiring a switch to an injectable MTX* or
  • currently treated with an injectable MTX* and eligible for a change of MTX injection device*
  • Patients informed about and accepting the computer processing of their medical data and their right of accesss and correction.

排除标准

  • Patients who refuse to participate in the study or are unable to fill out the patient diary.
  • *On the basis of the products marketed at the time of submission of the study to Oversight Authorities (Méthotrexate Biodim®, Metoject® and imeth®).

结局指标

主要结局

Rate of patients whose adherence to methotrexate (MTX) remained strong or improved between inclusion (V0) and follow-up (V1) at 6 months.

时间窗: 6 months

Patient adherence is measured via the Morisky score at V0 and V1, using patient-reported outcome (PRO).

次要结局

  • Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on socio-professional standing.(6 months after inclusion.)
  • Global and functional patient satisfaction with treatment after 6 months as assessed by the Likert scale for global satisfaction.(6 months after inclusion.)
  • Global and functional patient satisfaction with treatment after 6 months as assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI) for functional disability.(6 months after inclusion.)
  • Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on age.(6 months after inclusion.)
  • Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on comorbidities.(6 months after inclusion.)
  • Analysis of improvement or maintenance of patient adherence, as evaluated by the Morisky score at V0 and V1, based on global patient satisfaction (assessed by Likert scale results).(6 months after inclusion.)
  • Analysis of improvement or maintenance of patient adherence, evaluated by the change in the Morisky scores at V0 and V1, based on whether the injection was self-administered or administered by a third party.(6 months after inclusion.)
  • Comparison of patient adherence between the 2 cohorts.(6 months after inclusion.)
  • Global and functional patient satisfaction with treatment after 6 months as assessed by the Disease Activity Score 28 (DAS28) for disease severity.(6 months after inclusion.)
  • Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on family situation.(6 months after inclusion.)
  • Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on the co-administration of other injectable treatments.(6 months after inclusion.)
  • Reasons for non-adherence given by patients after 6 months.(6 months after inclusion.)
  • Global and functional patient satisfaction with treatment after 6 months as assessed by the Echelle de Mesure de l'Impact de la polyarthrite Rhumatoïde (EMIR) for quality of life.(6 months after inclusion.)
  • Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on the reasons for the switch to new MTX injection device.(6 months after inclusion.)
  • Treatment adherence, evaluated by the Morisky score at 6 months, as assessed by the HCP compared to the treatment adherence as reported by the patient .(6 months after inclusion.)
  • Analysis of improvement or maintenance of patient adherence, as evaluated by the change in the Morisky scores at V0 and V1, based on rheumatoid arthritis severity (assessed by DAS28).(6 months after inclusion.)
  • Analysis of improvement or maintenance of patient adherence, evaluated by the change in the Morisky scores at V0 and V1, based on patient functional handicap (assessed by the HAQ-DI).(6 months after inclusion.)
  • Analysis of improvement or maintenance of patient adherence, evaluated by the change in the Morisky scores at V0 and V1, based on tolerability and level of patient trust with HCP (assessed by Likert scale results).(6 months after inclusion.)
  • Doctor satisfaction with the treatment after 6 months.(6 months after inclusion.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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