The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease

IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001546-33-GB

Enrollment

200

Registered

2018-05-14

Start date

2018-07-11

Completion date

Unknown

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis MedDRA version: 20.1 Level: PT Classification code 10021972 Term: Inflammatory bowel disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Flixabi Product Name: Flixabi Pharmaceutical Form: Infusion INN or Proposed INN: Infliximab CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The principal inclusion criteria are; • All patients with IBD (Crohn’s Disease and Ulcerative Colitis) treated with =1 dose of CT-P13 at time of enrolment • Aged =18 years at time of enrolment • Planned continuation of infliximab treatment for at least 3 months after enrolment • Capable of providing written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Patients with the following characteristics are ineligible for this study • Unable to provide written informed consent • Involved in another IMP trial • Age < 18 years at time of enrolment • Planned discontinuation of treatment at UHS within 3 months of enrolment

Design outcomes

Primary

Measure	Time frame
Main Objective: This is a research study looking at the effects of switching from one biosimilar drug (CT-P13), used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another biosimilar drug (SB2), also used to treat UC or Crohn’s disease. CTP-13 (Inflectra, Remsima) and SB2 (Flixabi) are ‘biosimilars’ of Remicade, but work in the same way. The primary objective of this study is to evaluate the clinical outcome of switching a cohort of IBD patients from CT-P13 to SB2. Infliximab is a product originally produced and marketed by a single pharmaceutical company and given a brand name (Remicade). After a number of years, it is agreed that other companies can produce their own copies of Remicade. These copies are known as biosimilars and act in a similar way to the original product Remicade There are very tiny differences to the original product but we do not believe these affect how the drug works or it's safety and side effects. ;Secondary Objective: In addition the research will gather information to show the following: How UC or CD is managed after switching. How safe it is to switch from one Biosimilar drug to another How the immune system responds to this change Assess the quality of life after switching from CT-P13 (Inflectra, Remsima) to SB2 (Flixabi). Assess the patient life experiences after switching from CT-P13 (Inflectra, Remsima) to SB2 (Flixabi). ;Primary end point(s): The primary outcome measure is the clinical status as assessed by IBD control patient reported outcome measure, drug persistence laboratory measurements and appropriate validated disease activity scores. ;Timepoint(s) of evaluation of this end point: Clinical status at week 30 or week 32 (depending on the infusion regime)	—

Measure

Time frame

Main Objective: This is a research study looking at the effects of switching from one biosimilar drug (CT-P13), used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another biosimilar drug (SB2), also used to treat UC or Crohn’s disease. CTP-13 (Inflectra, Remsima) and SB2 (Flixabi) are ‘biosimilars’ of Remicade, but work in the same way. The primary objective of this study is to evaluate the clinical outcome of switching a cohort of IBD patients from CT-P13 to SB2. Infliximab is a product originally produced and marketed by a single pharmaceutical company and given a brand name (Remicade). After a number of years, it is agreed that other companies can produce their own copies of Remicade. These copies are known as biosimilars and act in a similar way to the original product Remicade There are very tiny differences to the original product but we do not believe these affect how the drug works or it's safety and side effects. ;Secondary Objective: In addition the research will gather information to show the following: How UC or CD is managed after switching. How safe it is to switch from one Biosimilar drug to another How the immune system responds to this change Assess the quality of life after switching from CT-P13 (Inflectra, Remsima) to SB2 (Flixabi). Assess the patient life experiences after switching from CT-P13 (Inflectra, Remsima) to SB2 (Flixabi). ;Primary end point(s): The primary outcome measure is the clinical status as assessed by IBD control patient reported outcome measure, drug persistence laboratory measurements and appropriate validated disease activity scores. ;Timepoint(s) of evaluation of this end point: Clinical status at week 30 or week 32 (depending on the infusion regime)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Incidence of Adverse Events, Serious Adverse Events, Adverse Events of Special Interest causally related to SB2 2. Immunogenicity as determined by presence of anti-drug antibodies (binding and /or circulating?) 3. Change from baseline to Week 24 and over time in patient reported outcomes or IBD PROM 4. Levels of laboratory inflammatory markers (faecal calprotectin, FBC, CRP and albumin) at baseline and over time during the study 5. Semi Structured interviews analysed using thematic analysis ;Timepoint(s) of evaluation of this end point: Clinical status at week 30 or week 32 (depending on the infusion regime)	—

Measure

Time frame

Secondary end point(s): 1. Incidence of Adverse Events, Serious Adverse Events, Adverse Events of Special Interest causally related to SB2 2. Immunogenicity as determined by presence of anti-drug antibodies (binding and /or circulating?) 3. Change from baseline to Week 24 and over time in patient reported outcomes or IBD PROM 4. Levels of laboratory inflammatory markers (faecal calprotectin, FBC, CRP and albumin) at baseline and over time during the study 5. Semi Structured interviews analysed using thematic analysis ;Timepoint(s) of evaluation of this end point: Clinical status at week 30 or week 32 (depending on the infusion regime)

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Countries

United Kingdom

Contacts

Public ContactDr Fraser Cummings

University Southampton Hospital NHS Trust

Fraser.Cummings@uhs.nhs.uk023 8077 7222

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026