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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 6 October 2020
Main ID:  EUCTR2018-001546-33-GB
Date of registration: 14/05/2018
Prospective Registration: Yes
Primary sponsor: University Southampton Hospital NHS Foundation Trust
Public title: 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
Scientific title: IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0
Date of first enrolment: 11/07/2018
Target sample size: 200
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-001546-33
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: CTP-13 Number of treatment arms in the trial: 1  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
United Kingdom
Contacts
Name: Dr Fraser Cummings   
Address:  Tremona Road SO16 6YD Southampton United Kingdom
Telephone: 023 8077 7222
Email: Fraser.Cummings@uhs.nhs.uk
Affiliation:  University Southampton Hospital NHS Trust
Name: Dr Fraser Cummings   
Address:  Tremona Road SO16 6YD Southampton United Kingdom
Telephone: 023 8077 7222
Email: Fraser.Cummings@uhs.nhs.uk
Affiliation:  University Southampton Hospital NHS Trust
Key inclusion & exclusion 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:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

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

Primary Outcome(s)
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.
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.
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).

Timepoint(s) of evaluation of this end point: Clinical status at week 30 or week 32 (depending on the infusion regime)
Secondary Outcome(s)
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)
Secondary ID(s)
RHMMED1526
Source(s) of Monetary Support
Biogen Idec Ltd
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 11/07/2018
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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