Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis

Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis - Efficacy and safety of IFX-BS in UC patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027465

Enrollment

Registered

2017-05-24

Start date

2017-05-29

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

ulcerative colitis

Interventions

Infliximab (5mg/kg, every 8 weeks, for 12 months) Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with ulcerative colitis treated with Infliximab 2) Being in the clinical remission state (partial Mayo's score <2, and CRP < 0.5mg/dl)

Exclusion criteria

Exclusion criteria: 1) Patients younger than 20 years old 2) Patients keeping in the clinical remission state for more than 10 years

Design outcomes

Primary

Measure	Time frame
The remission rate and the adverse events 24 and 48 weeks after the switch from infliximab to its biosimilar	—

Secondary

Measure	Time frame
The value of partial Mayo's score The value of serum CRP The value of serum albumin The value of hemoglobin The increase of Infliximab or biosimilar Infliximab	—

Countries

Japan

Contacts

Public ContactSohachi Nanjo

University of Toyama Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Scienc

snanjo@med.u-toyama.ac.jp076-434-7301

Outcome results

None listed

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