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临床试验/JPRN-jRCTs031200238
JPRN-jRCTs031200238已完成未知

Examination of the usefulness of apremilast in maintenance of remission in patients with psoriasis vulgaris who had remission with biologics (Targeting patients who evade biologics)

Ohtsuki Mamitaro0 个研究点目标入组 209 人开始时间: 2020年12月11日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
209

研究概览

简要总结

Overall patient satisfaction with biological agents in the treatment of psoriasis was high, but dissatisfaction and concern existed regarding the cost of treatment, prolonged treatment period, and the limited number of medical institutions where treatment could be received. The 24-week remission maintenance rate was 63.6%, and the remission maintenance period was 20.97 + - 1.05 weeks when patients in remission maintenance with biological agents were switched to treatment with apremilast.

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 ot applicable(—)
性别
All

入选标准

  • Questionnaire survey
  • 1) Patients with psoriasis vulgaris who have been in remission for more than 6 months with biologics
  • *Remission : Patients with PASI<2, BSA<2, and DLQI = 0 or 1
  • *In the case of complication of the psoriatic arthritis, patients with SJC = 0, TJC = 0, and HAQ-DI less than or equal 0.5
  • 2) Those who are 20 years of age or older at the time of registration
  • 3) Those who gave consent to participate in the survey after explaining the content of this research
  • Remission maintenance therapy that adding study drug to topical therapy
  • 1)Those who responded to the questionnaire survey and requested oral treatment to discontinue the biologics and add the study drug to the topical therapy as treatment during the remission maintenance period
  • 2)Those who obtained written informed consent to participate in remission maintenance therapy after explaining the content of this study

排除标准

  • Questionnaire survey
  • 1) Those who have participated in other clinical research, clinical trials, etc. within the past 3 months
  • 2)Others, which the investigator judges to be ineligible as a research subject
  • Remission maintenance therapy that adding study drug to topical therapy
  • 1)Those with hypersensitivity to the ingredients of the drug under study (corresponding to contraindications for Otezura tablets)
  • 2)Pregnant women or women who may be pregnant, women who wish to become pregnant during the study period
  • 3)Lactating women
  • 4)In addition, what the investigator determines to be ineligible as a research subject (eg, depression/suicidal thoughts Person)

研究者

发起方
Ohtsuki Mamitaro

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