Efficacy of Humira(Adalimumab) in patients with moderate to severe ulcerative colitis (KyuSyu IBD project)

Efficacy of Humira(Adalimumab) in patients with moderate to severe ulcerative colitis (KyuSyu IBD project) - HAWKS study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000019512

Enrollment

200

Registered

2015-10-27

Start date

2014-02-05

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: Patients with moderate to severe ulcerative colitis who administrate of adalimumab.

Exclusion criteria

Exclusion criteria: 1.Patients who Contraindicate for adalimumab. 2.Patients who can not provide informed consent. 3.Patients who have malignancy 4.Patients who judged to be disqualified by the physician

Design outcomes

Primary

Measure	Time frame
1.Short-term therapeutic outcome (Remission rate after 8 weeks) 2.Long-term therapeutic outcome (Remission rate after 52 weeks)	—

Secondary

Measure	Time frame
1. Short-term therapeutic outcome (Response rate and mucosal healing rate after 8 weeks) 2.Long-term therapeutic outcome (Response rate and mucosal healing rate after 52 weeks) 3.The factors for short- and long-term therapeutic outcome 4.Cumulative non-relapse and non-operation rate during 52 weeks 5.The factors for cumulative non-relapse and non- -operation rate	—

Countries

Japan

Contacts

Public ContactFumihito Hirai MD.PhD.

Fukuoka University Chikushi Department of Gastroenterology

fuhirai@cis.fukuoka-u.ac.jp092-921-1011

Outcome results