Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease

Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease - Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000043165

Enrollment

220

Registered

2021-01-31

Start date

2021-02-01

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

witching from originator infliximab to infliximab biosimilar CT-P13

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who will switch from originator infliximab to infliximab biosimilar CT-P13 2. Patients with consent to participate

Exclusion criteria

Exclusion criteria: 1. Patients who don't consent 2. Patients who are judged not suitable for this trial by the doctor

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	—

Secondary

Measure	Time frame
efficacy, cumulative continuation rate, risk factors for relapse, risk factors for adverse events, questionnaire survey, efficacy of infliximab biosimilar CT-P13 by trough of originator infliximab before switch	—

Countries

Japan

Contacts

Public ContactTeruyuki Takeda

Fukuoka University Chikushi Hospital Department of Gastroenterology

take5times@fukuoka-u.ac.jp092-921-1011

Outcome results

None listed

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