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Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease

Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease - Efficacy and safety of IFX-BS in CD patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026330
Enrollment
30
Registered
2017-02-28
Start date
2017-02-27
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 disease

Interventions

Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months) Biosimilar Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months)

Sponsors

University of Toyama
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with Crohn disease treated with Infliximab 2) Being in the clinical remission state (CDAI <150, 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

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

Secondary

MeasureTime frame
The value of clinical disease activity index 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