JPRN-jRCT1031210582招募中未知
Effectiveness and Safety of Adalimumab Biosimilar FKB327 with Ulcerative Colitis, Crohn's Disease, and Psoriatic Arthritis - FKB327 Registry Study
ozawa Kazutaka0 个研究点目标入组 300 人开始时间: 2022年1月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- >= 16age old 至 ot applicable（—）
- 性别
- All
入选标准
- •For biologic-naive patients
- •1)Patients diagnosed with UC, CD/patients diagnosed with PsA by Classification criteria for psoriatic arthritis (CASPAR)
- •2)Patients with moderate disease activity/Severe disease activity (for patients with UC, CD)/Patients who have not achieved functional remission with existing treatment (for patients with PsA)
- •= 6, based on findings over the past three days (for patients with UC)/HBI >= 8 , based on three clinical symptoms on the previous day and abdominal mass and complications at the time of the evaluation (for patients with CD)/HAQ > 0.5 (for patients with PsA) >
- •3)Biologic-naive patients
- •4)Male or female patients aged 16 years old or older (for patients with UC or CD) / Male or female patients 20 years of age or older (for patients with PsA)
- •5)Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. (However, the patient is limited to a person judged by the principal investigator or sub-investigator that he/she has capacity for adequate judgement.)
- •For patients switched from adalimumab originator to FKB327
- •1)Patients diagnosed with UC, CD/patients diagnosed with PsA by Classification criteria for psoriatic arthritis (CASPAR)
- •2)Patients who have been on adalimumab originator and in clinical remission* for at least 24 weeks at the point of 0 week. For PsA, patients who have been on adalimumab originator and in functional remission for at least 24 weeks at the point of 0 week.
- •3)Patients who are not using steroid drugs (for patients with UC, CD)
- •4)Male or female patients aged 16 years old or older (in patients with UC or CD) / Male or female patients 20 years of age or older (in patients with PsA)
- •5)Patients who have decided to switch from adalimumab originator to FKB327 due to medical reasons or patient preference
- •6)Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. (However, the patient is limited to a person judged by the principal investigator or sub-investigator that he/she has capacity for adequate judgement.)
排除标准
- •For biologic-naive patients
- •1)Patients who fall under any of the warnings or contraindications listed in the package insert
- •2)Patients participating in other clinical studies. However, this does not apply observational studies if the lead principal investigator, principal investigator, and researchers, etc. at the study site conducting the study enrollment determine that the observational studies will not give an effect on the evaluation of the effectiveness and safety of this study.
- •3)Patients judged by the principal investigator or sub-investigator as being inappropriate for some reason
- •For patients switched from adalimumab originator to FKB327
- •1)Patients who fall under any of the warnings or contraindications listed in the package insert
- •2)Patients participating in other clinical studies. However, this does not apply observational studies if the lead principal investigator, principal investigator, and researchers, etc. at the study site conducting the study enrollment determine that the observational studies will not give an effect on the evaluation of the effectiveness and safety of this study.
- •3)Patients judged by the principal investigator or sub-investigator as being inappropriate for some reason
研究者
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