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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)

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)

Fukudo Masahide

Sapporo Medical University Hospital

South-1, West-16, Chuo-ku, Sapporo

fukudom@sapmed.ac.jp

Fukudo Masahide

Sapporo Medical University Hospital

South-1, West-16, Chuo-ku, Sapporo

+81-11-688-9686

fukudom@sapmed.ac.jp

Recruiting

Aug. 23, 2021

Observational

Subjects 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.

Subjects 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.

Both

Ulcerative Colitis

D003093

Primary 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 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.

+81-11-611-2111

Sept. 09, 2021

No

none