NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1011210031

Registered date:23/08/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUlcerative Colitis
Date of first enrollment23/08/2021
Target sample size50
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomePrimary Outcome Measure for Pharmacokinetics: -Serum concentrations of tofacitinib during induction and maintenance therapy. Primary Outcome Measures for Efficacy: -The remission rates at Week 8 or 16 after induction therapy and at Week 52 during maintenance therapy. -The relapse rate during maintenance therapy. Primary Outcome Measures for Safety: -Incidence of adverse events and severe adverse events. -Incidence of serious infections (including COVID-19).
Secondary OutcomeSecondary Outcome Measure for Pharmacokinetics: -Urinary concentrations of tofacitinib and its metabolites (e.g., M9). Pharmacogenomic Endpoint: -Major single nucleotide polymorphisms of genes which may be associated with tofacitinib pharmacokinetics, including CYP3A4/3A5 and ABCB1/ABCG2. Exploratory Endpoints: -Mucosal concentrations of tofacitinib. -Mucosal mRNA expression levels of CYP3A4/3A5 and ABCB1/ABCG2.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Subject must be at least 20 years of age. 2. Subjects with a documented diagnosis of moderately to severely active ulcerative colitis. 3. Subjects who can provide informed consent.
Exclude criteriaSubjects presenting with any of the following will be excluded from the study: 1. Subjects who cannot provide informed consent. 2. Subjects who are participating in or interested in participating in other clinical trials during the study period. 3. Subjects who are judged as not suitable for participating in this study by treating physician.

Related Information

Contact

Public contact
Name Masahide Fukudo
Address South-1, West-16, Chuo-ku, Sapporo Hokkaido Japan 060-8543
Telephone +81-11-688-9686
E-mail fukudom@sapmed.ac.jp
Affiliation Sapporo Medical University Hospital
Scientific contact
Name Masahide Fukudo
Address South-1, West-16, Chuo-ku, Sapporo Hokkaido Japan 060-8543
Telephone +81-11-688-9686
E-mail fukudom@sapmed.ac.jp
Affiliation Sapporo Medical University Hospital