Investigation on the efficacy, safety, and prognosis of Carotegrast Methyl in patients with active ulcerative colitis - Multicenter observational study -

Investigation on the efficacy, safety, and prognosis of Carotegrast Methyl in patients with active ulcerative colitis - Multicenter observational study - - CANAL study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057285

Enrollment

200

Registered

2025-03-14

Start date

2025-03-11

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: 1)Patients aged 16 years or older at the time of obtaining consent 2)Patients who meet all of the following conditions 1 to 5 at the time of the first dose of Carotegrast Methyl 1,Patients aged 15 years or older 2,Patients who have not responded to or are intolerant of treatment with 5-ASA*1 3,Patients with moderate-to-severe*1 active UC(regardless of disease type) 4,Patients with Patient-Reported Outcome 2 (PRO2) (PRO2: total of Mayo frequency subscore and Mayo blood in stool subscore) of 2 points or more, and a blood in stool subscore of 1 point or more 5,Patients who have at least one PRO2 data during the treatment period (including the end of treatment) in addition to the first dose of Carotegrast Methyl . *1 The diagnosis will be determined according to the diagnostic criteria for ulcerative colitis. If there is no record of the diagnosis in the medical record, the EDC will be used as the original data.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria at the time of the first dose of Carotegrast Methyl will be excluded. 1)Patients who received concomitant therapy with immunomodulators (azathioprine, 6-mercaptopurine), immunosuppressants (tacrolimus, cyclosporine), Janus kinase inhibitors, biological products, or high-dose intravenous corticosteroid therapy during the first administration of Carotegrast Methyl 2)Patients who have used immunosuppressants (tacrolimus, cyclosporine), Janus kinase inhibitors, biological products, or high-dose intravenous corticosteroid therapy within the past year 3)Patients who received the initial dose of Carotegrast Methyl outside the approved dosage and administration of CAROGRA Tablets

Design outcomes

Primary

Measure	Time frame
Improvement rate of PRO-2 at 8 weeks of administration	—

Countries

Japan

Contacts

Public ContactFumihito Hirai

Fukuoka University Faculty of Medicine Department of Gastroenterology

fuhirai@cis.fukuoka-u.ac.jp092-801-1011

Outcome results