Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy

Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy - Comparison of maintenance treatment between azathioprine and adalimumab after induction of tacrolimus in ulcerative colitis therapy (CAT study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030988

Enrollment

Registered

2018-02-01

Start date

2018-02-01

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

Induce azathioprine and continue maintenance therapy by azathioprine Induce adalimumab and continue maintenance therapy by adalimumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Moderate to severe ulcerative colitis patients who are refractory to steroid therapy No history of immunomodulator, anti-TNF drug or calcineurin inhibitor within 1 year

Exclusion criteria

Exclusion criteria: Patients who are contraindicated of tacrolimus, azathioprine or adalimumab Female patients who are in lactation or desire to bear children Patients less than 15 years old Patients who do not consent to the trial Patients who had malignancy Patients who had intestinal resection within 6 months Patients who are short-bowel syndrome Patients who are not appropriate to participate to the trial

Design outcomes

Primary

Measure	Time frame
Comparison of non-relapse rates (1 year) between azathioprine group and adalimumab group	—

Secondary

Measure	Time frame
Comparison of side-effect rates (1 year) between azathioprine group and adalimumab group Comparison of clinical remission rates (1 year) between azathioprine group and adalimumab group Comparison of endoscopic remission rates (1 year) between azathioprine group and adalimumab group	—

Countries

Japan

Contacts

Public ContactYasuo Suzuki

Sakura Medical Center, Toho university Inflammatory bowel disease (IBD) center

yasuo-suzuki@sakura.med.toho-u.ac.jp043-462-8811

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026