Efficacy and Safety of biosimilar to Crohn's disease and ulcerative colitis: prospective cohort observational study

Efficacy and Safety of biosimilar to Crohn's disease and ulcerative colitis: prospective cohort observational study - IBD biosimilar study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053025

Enrollment

100

Registered

2023-12-07

Start date

2024-01-04

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

Crohn&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Crohn's disease or ulcerative colitis patients treated or scheduled to start Infliximab or Adalimumab

Exclusion criteria

Exclusion criteria: 1. Patients without definite diagnosis of Crohn's disease or ulcerative colitis. 2. Patients who have previously received either Infliximab BS or Adalimumab BS. 3. Patients who are judged by the researchers to be unsuitable as research subjects.

Design outcomes

Primary

Measure	Time frame
Clinical remission rate after 1 year and 3 years	—

Countries

Japan

Contacts

Public ContactYuichi Shimodate

Kurashiki Central Hospital Center for IBD

ys13544@kchnet.or.jp086-422-0210

Outcome results