Multicenter Registry Study on the Efficacy and Safety of Anti-IL-23p19 Antibodies for Ulcerative Colitis

Multicenter Registry Study on the Efficacy and Safety of Anti-IL-23p19 Antibodies for Ulcerative Colitis - QUALT19 Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055475

Enrollment

200

Registered

2024-09-11

Start date

2024-04-05

Completion date

Unknown

Last updated

2026-09-14

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: Patients diagnosed with ulcerative colitis (UC) and receiving treatment with anti-IL-23p19 antibodies at Saga University Hospital and affiliated research institutions from the date of approval notification issuance to March 31, 2027. Patients aged 18 years or older. Patients under 18 years of age with consent obtained from their legal representatives.

Exclusion criteria

Exclusion criteria: Individuals who do not consent to the purpose of this observational study. Cases where the attending physician determines that participation in the research is inappropriate.

Design outcomes

Primary

Measure	Time frame
Clinical remission at 4 weeks, 12 weeks, 28 weeks, and 52 weeks after initiation of treatment pMS 1 or less and rectal bleeding subscore of 0	—

Secondary

Measure	Time frame
The proportions of patients achieving pMS-based clinical response, defined as a decrease of at least 2 points from baseline, corticosteroid-free clinical remission, rescue-free clinical remission, IBDQ remission, defined as an IBDQ total score 170 or more, IBDQ response, defined as an increase of at least 16 points from baseline, and biomarker remission at weeks 4, 12, 28 and 52 after treatment initiation, together with the incidence and types of adverse events. SCCAI-based clinical remission was defined as an SCCAI score 2 or less, and SCCAI-based clinical response as a decrease of at least 3 points from baseline. The proportions of patients achieving endoscopic remission, defined as a Mayo endoscopic subscore of 0, and endoscopic improvement, defined as a Mayo endoscopic subscore 1 or less, at week 52. Changes in corticosteroid dose over time. Index-treatment continuation rates. Factors associated with the successful induction and maintenance of remission.	—

Measure

Time frame

The proportions of patients achieving pMS-based clinical response, defined as a decrease of at least 2 points from baseline, corticosteroid-free clinical remission, rescue-free clinical remission, IBDQ remission, defined as an IBDQ total score 170 or more, IBDQ response, defined as an increase of at least 16 points from baseline, and biomarker remission at weeks 4, 12, 28 and 52 after treatment initiation, together with the incidence and types of adverse events. SCCAI-based clinical remission was defined as an SCCAI score 2 or less, and SCCAI-based clinical response as a decrease of at least 3 points from baseline. The proportions of patients achieving endoscopic remission, defined as a Mayo endoscopic subscore of 0, and endoscopic improvement, defined as a Mayo endoscopic subscore 1 or less, at week 52. Changes in corticosteroid dose over time. Index-treatment continuation rates. Factors associated with the successful induction and maintenance of remission.

—

Countries

Japan

Contacts

Public ContactSadashima Kento

Saga University Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine

s_kent66@yahoo.co.jp0952-31-6511

Outcome results