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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1011210031

Enrollment

Registered

2021-08-23

Start date

2021-08-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactMasahide Fukudo

Sapporo Medical University Hospital

fukudom@sapmed.ac.jp+81-11-688-9686

Outcome results