Inflammatory Bowel DiseasesNCT05719389
EFFICACY AND SAFETY OF S.C. INFLIXIMAB IN PATIENTS SWITCHED FROM I.V. FORMULATION OF INFLIXIMAB
An observational study of Inflammatory Bowel Diseases and Rheumatologic Disease, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Phase-IV, national, multicentric, non-randomized, observational real-life study. The goal of this stud is to investigate the patient's benefits in terms of quality of life and work ability resulting from the switch from infliximab i.v. to s.c. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Rheumatologic Disease
- What is being tested?
- CT-P13
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 14 Sep 2022to 20 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 250 patients with any indication will be enrolled. Since no previous data are available from the literature, this is a number which is considered reasonable to get adequate magnitude to support the validity of the expected data for the primary outcome. At least 10 hospitals across Italy will be involved, where IBD patients and patients with rheumatological disease are regularly followed-up and treated for their condition. The enrollment will be competitive, although all measures will be taken to allow adequate balance in the number of patients enrolled in each center, and in the number of patients with gastroenterological or rheumatological conditions.
Who may be able to join
- Male or female patient of ≥18 years age and no upper age limit
- Patients with confirmed diagnosis of at least one of the following conditions: Crohn's disease; ulcerative colitis; rheumatoid arthritis4 (2010 ACR/EULAR criteria); ankylosing spondylitis (according to the ASAS modification of the Berlin algorithm for diagnosing ankylosing spondylitis)5; psoriatic arthritis (CASPAR criteria)6.
- Exposed to i.v. infliximab for at least the minimum time required by the current SmPC, and switched to infliximab s.c. 120 mg q2w prior or at the time of to the inclusion in this study.
- Treatment with infliximab is according to local approved label
- Full ability to understand the study procedures and to sign an informed consent form
Who cannot join
- Known intolerance/allergy/reaction to infliximab or any excipient included in the s.c. infliximab formulation
- Non confirmed diagnosis of IBD (unclassified IBD) or not classifiable as having RA or AxSpA or PsA according to the respective criteria
- Cardiac insufficiency grade IV according to the NYHA scale
- Active infection at the time of inclusion
- Pregnancy or lactation at the time of inclusion
- Active malignancy at the time of inclusion
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Irccs Ospedale San Raffaele
Milan, 20132
Silvio Danese, 0226439494, ibd.trials@hsr.it
About this study
Phase-IV, national, multicentric, non-randomized, observational real-life study. The goal of this stud is to investigate the patient's benefits in terms of quality of life and work ability resulting from the switch from infliximab i.v. to s.c. in patients with gastroenterological or rheumatological indication at month 12.Patients who are eligible but were switched before the inclusion in this study will also be enrolled, and the data already collected according to clinical practice and consistent with the study outcome measures will be used retrospectively. All patients will be followed up according to the standard of care of each participating center.
The main questions it aims to answer are:
Read more
- To investigate the effectiveness at month 2, 6 and 12 after switching to infliximab s.c.
- To investigate the safety profile at month 2, 6 and 12 after switching to infliximab s.c.
- To investigate the difference between patients with rheumatological diseases and patients with IBD in terms of quality of life and work, effectiveness and safety at month 2, 6 and 12 after switching.
- To investigate the presence of baseline predictors for drug persistence at month 12 (sex, age, disease type, disease severity, body mass index, concomitant medications, smoking habit, presence of comorbidities).
- To investigate whether there is any change between baseline and week 52 in the following aspects:
- Job type and need for any authorization to go to the hospital to receive the study drug
- Distance and duration of the travel home-hospital
- Mode of travel home-hospital
- Need for a caregiver to be present
- Time spent at hospital
- Patient's preference for the way of study drug administration expressed on a 10-grades VAS scale.
The study period for observation will be 12 months from the date of switch. At week 0, month 2, 6 and 12 from the date of the switch, clinical activity, safety data and biomarker levels will be collected.
For those patients who have had an endoscopic evaluation of the disease within 2 months of inclusion and repeat the endoscopic evaluation at 12 months ± 8 weeks, endoscopic data will also be collected (valid only in the presence of IBD).
In those centers where a blood sample to analyze the minimum levels and anti-drug antibodies of infliximab has been collected and/or stored within 2 months prior to the date of transition, the patient will be asked to give informed consent to the use of this sample and to provide a blood sample for the same analysis at week 0, month 2 and 12. These samples will be analyzed and compared to evaluate the immunogenicity of the drug. These analyzes will be centralized in one lab.
Read the detailed description
250 patients with confirmed diagnosis of Crohn's disease or ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis;, aged≥ 18, with full ability to understand study procedures and sign an informed consent form, exposed to infliximab i.v. for at least the minimum time required by the current SmPC, and switched to infliximab s.c. 120 mg q2w since the launch date of s.c. infliximab into the Italian market will be prospectively enrolled.
Descriptive analyses will be used for all results. Since there is no control arm, a comparison will be made between the study outcomes and the expected rates reported in the literature for patients treated with infliximab. Survival analyses will be used to acquire and analyze safety and treatment persistence endpoints. Depending on the normality in the distribution of the variables, parametric and non-parametric tests will be used to perform the appropriate statistical analyzes. For all statistical analyzes, a p value <0.05 will be considered as the limit for significance.
Enrollment period:18 months after the approval of the relevant ethical committee Observational period for each patient:12 months from the date of switch
Statistical analysis and publication of results: 6 months after the last patient's follow-up time completion:
Total duration: 3 years
- Conditions
- Inflammatory Bowel Diseases, Rheumatologic Disease
- Being tested
- CT-P13
- Medical subject headings
- Inflammatory Bowel Diseases, Collagen Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P13Drug
CT-P13 is a biosimilar of infliximab approved by EMA since 2015, and it is administered intravenously (i.v.) at a standard dose of 5 mg/kg at week 0, 2, 6 and then every 8 weeks, although the scheduled maintenance regimen can be optimized by administering the drug every 4-6 weeks or increasing the dose up to 10 mg/kg2.The safety profile of CT-P13 SC was comparable to that of CT-P13 i.v.; There were also fewer patients with positive anti-drug antibodies with CT-P13 SC than with CT-P13 i.v.3 At the moment, no data are available on the effectiveness, safety and immunogenicity in a real-world population of patients who have been switched from i.v. to s.c. infliximab.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with stable or improved from baseline WPAI and SF-36 scores at month 12 s.c. in patients with gastroenterological or rheumatological indication at month 12.
Proportion of patients with stable or improved from baseline WPAI and SF-36 scores at month 12 s.c. in patients with gastroenterological or rheumatological indication at month 12.
Measured: 12 months
Secondary outcomes (3)
Proportion of patients with normal or improved clinical scores at month 2, 6, and 12
Proportion of patients with normal or improved clinical scores at month 2, 6, and 12
Measured: 12 months
Number, severity, and type of adverse events/ seriuos adverse events through month 12
Number, severity, and type of adverse events/ seriuos adverse events through month 12
Measured: 12 months
f) Difference between patients with rheumatological diseases and patients with IBD in terms of quality of life and work, effectiveness and safety at month 2, 6 and 12 after switching
- Difference between patients with rheumatological diseases and patients with IBD in terms of quality of life and work, effectiveness and safety at month 2, 6 and 12 after switching
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start14 Sep 2022
- Primary completion20 Oct 2023 (estimated)
- Study completion20 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvio Danese, IRCCS San Raffaele
- Investigators
- Silvio Danese, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719389
- Sponsor's protocol ID
- BIO BETTER SWITCH
- Status last verified
- Jan 2023
- First submitted
- 30 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY AND SAFETY OF S.C. INFLIXIMAB IN PATIENTS SWITCHED FROM I.V. FORMULATION OF INFLIXIMAB
- ClinicalTrials.gov ID
- NCT05719389
- Acronym / sponsor ID
- BIO BETTER SWITCH
- Conditions
- Inflammatory Bowel Diseases, Rheumatologic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 20 Apr 2025 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase-IV, national, multicentric, non-randomized, observational real-life study. The goal of this stud is to investigate the patient's benefits in terms of quality of life and work ability resulting from the switch from infliximab i.v. to s.c. in patients with gastroenterological or rheumatological indication at month 12.Patients who are eligible but were switched before the inclusion in this study will also be enrolled, and the data already collected according to clinical practice and consistent with the study outcome measures will be used retrospectively. All patients will be followed up according to the standard of care of each participating center.
The main questions it aims to answer are:
- To investigate the effectiveness at month 2, 6 and 12 after switching to infliximab s.c.
- To investigate the safety profile at month 2, 6 and 12 after switching to infliximab s.c.
- To investigate the difference between patients with rheumatological diseases and patients with IBD in terms of quality of life and work, effectiveness and safety at month 2, 6 and 12 after switching.
- To investigate the presence of baseline predictors for drug persistence at month 12 (sex, age, disease type, disease severity, body mass index, concomitant medications, smoking habit, presence of comorbidities).
- To investigate whether there is any change between baseline and week 52 in the following aspects:
- Job type and need for any authorization to go to the hospital to receive the study drug
- Distance and duration of the travel home-hospital
- Mode of travel home-hospital
- Need for a caregiver to be present
- Time spent at hospital
- Patient's preference for the way of study drug administration expressed on a 10-grades VAS scale.
The study period for observation will be 12 months from the date of switch. At week 0, month 2, 6 and 12 from the date of the switch, clinical activity, safety data and biomarker levels will be collected.
For those patients who have had an endoscopic evaluation of the disease within 2 months of inclusion and repeat the endoscopic evaluation at 12 months ± 8 weeks, endoscopic data will also be collected (valid only in the presence of IBD).
In those centers where a blood sample to analyze the minimum levels and anti-drug antibodies of infliximab has been collected and/or stored within 2 months prior to the date of transition, the patient will be asked to give informed consent to the use of this sample and to provide a blood sample for the same analysis at week 0, month 2 and 12. These samples will be analyzed and compared to evaluate the immunogenicity of the drug. These analyzes will be centralized in one lab.
Detailed description
250 patients with confirmed diagnosis of Crohn's disease or ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis;, aged≥ 18, with full ability to understand study procedures and sign an informed consent form, exposed to infliximab i.v. for at least the minimum time required by the current SmPC, and switched to infliximab s.c. 120 mg q2w since the launch date of s.c. infliximab into the Italian market will be prospectively enrolled.
Descriptive analyses will be used for all results. Since there is no control arm, a comparison will be made between the study outcomes and the expected rates reported in the literature for patients treated with infliximab. Survival analyses will be used to acquire and analyze safety and treatment persistence endpoints. Depending on the normality in the distribution of the variables, parametric and non-parametric tests will be used to perform the appropriate statistical analyzes. For all statistical analyzes, a p value <0.05 will be considered as the limit for significance.
Enrollment period:18 months after the approval of the relevant ethical committee Observational period for each patient:12 months from the date of switch
Statistical analysis and publication of results: 6 months after the last patient's follow-up time completion:
Total duration: 3 years
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 250 patients with any indication will be enrolled. Since no previous data are available from the literature, this is a number which is considered reasonable to get adequate magnitude to support the validity of the expected data for the primary outcome. At least 10 hospitals across Italy will be involved, where IBD patients and patients with rheumatological disease are regularly followed-up and treated for their condition. The enrollment will be competitive, although all measures will be taken to allow adequate balance in the number of patients enrolled in each center, and in the number of patients with gastroenterological or rheumatological conditions.
Key inclusion criteria (5 listed)
- Male or female patient of ≥18 years age and no upper age limit
- Patients with confirmed diagnosis of at least one of the following conditions: Crohn's disease; ulcerative colitis; rheumatoid arthritis4 (2010 ACR/EULAR criteria); ankylosing spondylitis (according to the ASAS modification of the Berlin algorithm for diagnosing ankylosing spondylitis)5; psoriatic arthritis (CASPAR criteria)6.
- Exposed to i.v. infliximab for at least the minimum time required by the current SmPC, and switched to infliximab s.c. 120 mg q2w prior or at the time of to the inclusion in this study.
- Treatment with infliximab is according to local approved label
- Full ability to understand the study procedures and to sign an informed consent form
Key exclusion criteria (6 listed)
- Known intolerance/allergy/reaction to infliximab or any excipient included in the s.c. infliximab formulation
- Non confirmed diagnosis of IBD (unclassified IBD) or not classifiable as having RA or AxSpA or PsA according to the respective criteria
- Cardiac insufficiency grade IV according to the NYHA scale
- Active infection at the time of inclusion
- Pregnancy or lactation at the time of inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-P13CT-P13 is a biosimilar of infliximab approved by EMA since 2015, and it is administered intravenously (i.v.) at a standard dose of 5 mg/kg at week 0, 2, 6 and then every 8 weeks, although the scheduled maintenance regimen can be optimized by administering the drug every 4-6 weeks or increasing the dose up to 10 mg/kg2.The safety profile of CT-P13 SC was comparable to that of CT-P13 i.v.; There were also fewer patients with positive anti-drug antibodies with CT-P13 SC than with CT-P13 i.v.3 At the moment, no data are available on the effectiveness, safety and immunogenicity in a real-world population of patients who have been switched from i.v. to s.c. infliximab. | Drug | – |
Primary outcome
Proportion of patients with stable or improved from baseline WPAI and SF-36 scores at month 12 s.c. in patients with gastroenterological or rheumatological indication at month 12.
Time frame: 12 months
Proportion of patients with stable or improved from baseline WPAI and SF-36 scores at month 12 s.c. in patients with gastroenterological or rheumatological indication at month 12.
3 secondary outcomes
Proportion of patients with normal or improved clinical scores at month 2, 6, and 12
Time frame: 12 months
Number, severity, and type of adverse events/ seriuos adverse events through month 12
Time frame: 12 months
f) Difference between patients with rheumatological diseases and patients with IBD in terms of quality of life and work, effectiveness and safety at month 2, 6 and 12 after switching
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvio Danese principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Rheumatologic Disease, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvio Danese (0226432069, ibd.trials@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with stable or improved from baseline WPAI and SF-36 scores at month 12 s.c. in patients with gastroenterological or rheumatological indication at month 12. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.