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临床试验/NL-OMON49692
NL-OMON49692已完成不适用

Dose REduction Strategy Study of TNF inhibitors in Psoriatic arthritis and axial Spondyloarthritis patients. - DRESS-PS

Sint Maartenskliniek0 个研究点目标入组 95 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
95

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

  • - Eligible patients are >= 16 years of age at the time of signing the informed
  • consent form AND
  • 1) have peripheral SpA of the psoriatic arthritis subtype diagnosed clinically
  • by the rheumatologist , supported by the Classification Criteria for Psoriatic
  • Arthritis (CASPAR) and/or
  • 2) have axial SpA of the axial spondyloarthritis subtype, supported by the
  • Assessment of SpondyloArthritis international Society (ASAS) classification
  • criteria for axSpA, AND
  • - Are using full dose, or at least > 50% of the authorized defined daily dose
  • (DDD), of an originator or biosimilar TNFi (adalimumab, certolizumab,
  • etanercept, golimumab, infliximab);
  • - Patients have to have stable LDA, Psoriatic Arthritis Disease Activity Score
  • (PASDAS) <= 3.2 and a skin measure of body surface area involvement (modified
  • BSA) using a target of 3% as used by rheumatologists in clinical practice for
  • PsA and/or Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 and an
  • absence of active extra-axial symptoms such as Crohn*s disease, uveitis,
  • colitis or psoriasis for axSpA, for at least 6 months, or when formal
  • measurements are not available, judgement of physician and patient.

排除标准

  • - Previous recorded unsuccessful dose reduction of TNFi in the previous 24
  • - Comorbidities expected to hamper successful dose reduction (e g Crohns
  • disease, Ulcerative colitis, Psoriasis, Uveitis),
  • - Not able to have 12 months follow-up (life expectancy, planned relocation),
  • - Not able to measure outcome (language, other limitations)

研究者

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