jRCT1011210031招募中不适用
A multicenter study to investigate Oral JAK inhibitor Pharmacogenomics and Exposure-Response relationship in Japanese adult patients with moderately to severely Active ulcerative colitis during the COVID-19 pandemic (OPERA study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 主要终点
- Serum concentrations of tofacitinib
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
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •Subject must be at least 20 years of age.
- •Subjects with a documented diagnosis of moderately to severely active ulcerative colitis.
- •Subjects who can provide informed consent.
排除标准
- •Subjects presenting with any of the following will be excluded from the study:
- •Subjects who cannot provide informed consent.
- •Subjects who are participating in or interested in participating in other clinical
- •trials during the study period.
- •Subjects who are judged as not suitable for participating in this study by treating physician.
结局指标
主要结局
Serum concentrations of tofacitinib
Serum concentrations of tofacitinib during induction and maintenance therapy.
Remission rates
时间窗: Week 8 or 16 after induction therapy and Week 52 during maintenance therapy
The remission rates at Week 8 or 16 after induction therapy and at Week 52 during maintenance therapy.
Relapse rate
时间窗: during maintenance therapy
The relapse rate during maintenance therapy.
Incidence of adverse events and severe adverse events
Incidence of adverse events and severe adverse events.
Incidence of serious infections
Incidence of serious infections (including COVID-19).
次要结局
- Urinary concentrations of tofacitinib and its metabolites
- Major single nucleotide polymorphisms of genes
- Mucosal concentrations of tofacitinib
- Mucosal mRNA expression levels of CYP3A4/3A5 and ABCB1/ABCG2
研究者
相似试验
招募中
不适用
A multicenter study to investigate Oral JAK inhibitor Pharmacogenomics and Exposure-Response relationship in Japanese adult patients with moderately to severely Active ulcerative colitis during the COVID-19 pandemiclcerative ColitisD003093JPRN-jRCT1011210031Fukudo Masahide50
进行中（未招募）
不适用
A Randomized Study of the JAK Inhibitor INCB018424 Tablets Compared to Best Available Therapy in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) - COMFORT IIMedDRA version: 12.0Level: LLTClassification code 10028537Term: MyelofibrosisMyelofibrosisEUCTR2009-009858-24-ITIncyte Corporation150
尚未招募
Unknown
A comparative study between efficacy of topical JAK inhibitor alone versus JAK inhibitor with phototherapy in vitiligo patientsCTRI/2024/07/070001Dr Sneha Ulhaskumar Arakeri
进行中（未招募）
3 期
To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic ArthritisPsoriatic ArthritisNCT04957550Jiangsu HengRui Medicine Co., Ltd.418
进行中（未招募）
1 期
Inhibition of JAK Enzymes in early stage Joint inflammatioPreclinical Phase of rheumatoid arthritisMedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2021-006562-20-DEniversitätsklinikum Erlangen20