Evaluation of Adalimumab therapy in Mesalazine refractory or intolerant Ulcerative colitis: An observational study

Evaluation of Adalimumab therapy in Mesalazine refractory or intolerant Ulcerative colitis: An observational study - EARLY trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000020785

Enrollment

Registered

2016-01-28

Start date

2016-01-14

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: Mesalazine refractory or intolerant Ulcerative colitis

Exclusion criteria

Exclusion criteria: 1) Less than 15 years old 2) Patients that may be pregnant or pregnant 3) Patients with malignant tumor 4) Patients with serious infections 5) Patients with a treatment history of adalimumab 6) Contraindication of adalimumab 7) Patients consent can not be obtained on the clinical research participation 8) Patients who are otherwise classified as unfit by the attending physicians for the research.

Design outcomes

Primary

Measure	Time frame
remission rate	—

Countries

Japan

Contacts

Public ContactToshiharu Sakurai

KINKI University Faculty of Medicine Department of Gastroenterology and Hepatology

sakurai@med.kindai.ac.jp072-366-0221

Outcome results