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临床试验/EUCTR2015-004858-17-NL
EUCTR2015-004858-17-NL进行中(未招募)1 期

REMission INDuction in very early Rheumatoid Arthritis - REMINDRA

niversity Medical Center Utrecht (UMCU)0 个研究点目标入组 267 人开始时间: 2016年9月28日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
267

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • To be eligible to participate in this study, a subject must meet all of the following criteria:
  • -Able and willing to give written informed consent
  • -At least 18 years of age
  • -Fulfilling 2010 ACR/EULAR criteria for RA (Appendix A.)
  • -Patient reported symptom duration (joint stiffness, tenderness, pain, and/or swelling) < 12 months
  • -Naïve for DMARD and biological treatment
  • -Naïve for previous use of glucocorticoids for RA
  • -DAS28 =>3.2
  • -Have sufficient knowledge of the Dutch language to be able to comply with the requirements of the study protocol
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 267
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 267

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • -Being pregnant or a nursing women or a women of child bearing potential without (adequate) use of contraception
  • -Having any other inflammatory rheumatic disease than RA, except for secondary Sjögren’s syndrome
  • -Having contraindications for the use of MTX/HCQ/methylprednisolone/GOL.

研究者

发起方
niversity Medical Center Utrecht (UMCU)

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