Efficacy of tight control management on Japanese Crohn's disease patients treated with biologics: a multicenter prospective cohort study

Efficacy of tight control management on Japanese Crohn's disease patients treated with biologics: a multicenter prospective cohort study - Efficacy of tight control management on Japanese CD patients treated with biologics

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000034662

Enrollment

100

Registered

2018-10-29

Start date

2018-10-29

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: Ileal, colonic, or ileocolonic Crohn's disease patients treated with biologics (anti-TNF agents, ustekinumab or vedolizumab)

Exclusion criteria

Exclusion criteria: 1) Patients with severe infection (sepsis, etc.) 2) Patients with active tuberculosis 3) Patients with history of hypersensitivity to the ingredient of anti-TNF antibody, ustekinumab, or vedolizumab, or the protein of mouse origin 4) Patients with demyelinating disease (multiple sclerosis, etc.) or with history of demyelinating disease 5) Patients with congestive heart failure 6) Patients treated with two or more biologics in combination 7) Patients under 16 years old 8) Patients judged as inappropriate by physicians

Design outcomes

Primary

Measure	Time frame
Clinical remission and mucosal healing rates 52 weeks after the treatment with biologics	—

Secondary

Measure	Time frame
Rate of major adverse outcomes (hospitalization, surgery, discontinuation due to treatment failure) Factors associated with clinical remission, mucosal healing or major adverse outcomes	—

Countries

Japan

Contacts

Public ContactHisashi Shiga

Tohoku University Hospital Division of Gastroenterology

shiga@med.tohoku.ac.jp022-717-7171

Outcome results