跳至主要内容
临床试验/NL-OMON53234
NL-OMON53234招募中不适用

TrEatment Targets in Rheumatoid Arthritis: a randomized multi-centre, treat to target strategy trial: TETRA study - TETRA

Sint Maartenskliniek0 个研究点目标入组 340 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
340

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Diagnosis of RA (according to the 2010 ACR/ EULAR classification criteria
  • and/or clinical diagnosis)
  • - Aged 16 years or older
  • - At most low disease activity, operationalised as DAS28-CRP <3.5 (DAS28 CRP
  • 2.9 cut off for low disease activity with measurement error 0.6) or SDAI < 19
  • (SDAI 11 cut off for low disease activity with measurement error 8) or the
  • rheumatologist*s opinion. A state of low disease activity is required at
  • inclusion, as for RA patients in moderate or high disease activity there is no
  • equipoise on the best course of action (treatment needs to be escalated, both
  • in case of aiming for remission or LDA).
  • - Fluency of Dutch or English, both written and verbally; able to fill in
  • questionnaires
  • - Provided informed consent

排除标准

  • - Clinical deep remission, operationalised as SDAI <3.3 or DAS28-CRP
  • <2.4, AND a taper attempt in the past 2 years that was discontinued due to
  • occurrence of flare.
  • - Fewer than 3 DMARD treatment options left for this patient (severe
  • difficult-to-treat or refractory RA)
  • - Current severe comorbidity or other serious life-shortening conditions
  • hampering trial participation
  • - Inability to comply with the study protocol or to provide informed consent
  • with regard to intervention control and measuring outcomes

研究者

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