A multi-Center, prospective study for maintenance of remission after discontinuation of adalimumab therapy in ulcerative colitis patients

A multi-Center, prospective study for maintenance of remission after discontinuation of adalimumab therapy in ulcerative colitis patients - ROSE Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020840

Enrollment

Registered

2016-02-02

Start date

2016-02-02

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

discontinuation of adalimumab therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with adalimumab-induced remission for more than 6 months (1)Partial Mayo score is 2 points or less , with no individual subscore exceeding 1 point (2)Negative CRP 2.Patients with informed consent for this study by document

Exclusion criteria

Exclusion criteria: 1.Patients with serious infection (sepsis etc.) 2.Patients with active tuberculosis 3.Patients with a history of hypersensitivity to any of the ingredients of Humira 4.Patients with a current or past history of demyelinating diseases (multiple sclerosis, etc.) 5.Patients with congestive heart failure 6.Patients with pregnancy or desiring for pregnancy 7.Patients with history of colectomy 8.Patients without informed consent 9.Patients who are considered ineligible for this study by the principal investigator

Design outcomes

Primary

Measure	Time frame
rate of sustained remission after discontinuation of adalimumab therapy	—

Countries

Japan

Contacts

Public ContactTatsuya Toyokawa

Fukuyama Medical Center Department of Gastroenterology

toyotatu@kmail.plala.or.jp084-922-0001

Outcome results

None listed

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