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临床试验/EUCTR2013-004918-18-BE
EUCTR2013-004918-18-BE进行中(未招募)1 期

Optimising adalimumab treatment in psoriasis with concomitant methotrexate. - OPTIMAP

Ghent University Hospital0 个研究点目标入组 100 人开始时间: 2015年4月8日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
100

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

性别
All

入选标准

  • Have a diagnosis of moderate to severe plaque psoriasis (PASI=8 at time of screening);
  • Is a candidate for the treatment with biologic drugs according to the pertaining guidelines;
  • Willing and able to use an adequate contraceptives during the study (all men and pre-menopausal women);
  • Adalimumab therapy will be started for the treatment of psoriasis
  • Signed informed consent.
  • 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 4
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 2

排除标准

  • History of significant MTX or adalimumab toxicity, intolerability or contraindication
  • Prior treatment with adalimumab
  • Age < 18 years;
  • Pregnant and nursing women.
  • -other immunosuppressive medication (prednisone, mycofenolaatmofetyl (Cellcept e.g.), ciclosporine (Neoral e.g.), sirolimus (Rapamune), systemic tacrolimus (Prograft e.g.) e.g.)

研究者

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