IBDSHUFFLENCT06381518
Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease
A study testing Switch to SC CT-P13. in people with IBD and Infliximab, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
The aim of this study is to evaluate the IFX exposure (AUC), effectiveness, presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBD, Infliximab, Crohn Disease
- What is being tested?
- Switch to SC CT-P13.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Mar 2024to 1 Dec 2025
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18-75 years) with an confirmed diagnosis of IBD according to usual criteria, including previous endoscopic examination.
- Patients on IV IFX maintenance therapy at a stable dose and dosing interval for at least 16 weeks of 5-10 mg/kg every 6-8 weeks without side effects of IFX.
- IBD in clinical remission for at least 16 weeks without treatment with systemic corticosteroids in the previous 16 weeks. Clinical remission in adult patients is defined as a Harvey-Bradshaw index (HBI) < 4 for CD [18] or a partial Mayo Index (PMI) <2 for UC [19], with faecal calprotectin levels <250 μg/g faeces and CRP <10 mg/L.
- Concomitant immunomodulators are allowed, i.e. in stable doses were received for at least 12 weeks prior to study enrolment. These doses will be continued throughout the study, including azathioprine (AZA), 6-mercaptopurine (6-MP), tioguanine (TG) and MTX.
- Written informed consent
Who cannot join
- Patient <18 years of age.
- Allergy or hypersensitivity to any of the excipients of SC CT-P13.
- Patient with active perianal fistula.
- Patient with another autoimmune disease in addition to IBD.
- Patient treated concomitantly with another Mab in addition to IFX.
- Patients who, after starting IV IFX, have developed new contraindications to IFX according to European Public Assessment Report (EPAR).[3]
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- Female patient who is currently pregnant or breastfeeding, or is planning to become pregnant or breastfeed within 6 months of the last dose of IFX.
- Patient has a serious acute or chronic medical or psychiatric condition that might increase the risk associated with study participation or investigational product administration or that might interfere with the interpretation of study results.
- Patients who, in the opinion of their general practitioner or investigator, should not participate in the study (e.g. non-adherence, mental health problems, illiteracy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease: Evaluation of Exposure Parameters
The aim of this study is to evaluate the IFX exposure (AUC), effectiveness, presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator.
Methods: this is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX (cohort 2). After the switch to SC CT-P13, patients are followed for 24 weeks.
The study is subdivided into two phases: the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch. After enrolment, the subject receives a final dose of IV IFX according to their own maintenance schedule. Primary endpoints are the Area under the concentration-time curve (AUC) at steady state (1) before and after the switch to SC CT-P13 and (2) with or without concomitant immunomodulator during SC therapy. AUCs will be estimated using pharmacokinetic modelling in MwPharm. Besides IFX trough level, treatment related time expenditure, quality-of-life and patient satisfaction will be assessed before and after the switch.
Read the detailed description
On demand.
- Conditions
- IBD, Infliximab, Crohn Disease, Ulcerative Colitis
- Being tested
- Switch to SC CT-P13.
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switch to SC CT-P13.Other
all patients in the study will switch from IFX to SC CT-P13
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Infliximab monotherapy | Other | Adult patients (18-75 years old) on maintenance monotherapy of IV IFX. Receives: Other: Switch to SC CT-P13. |
| Cohort 2: infliximab combination therapy | Other | Adult patients on maintenance combination therapy of IV IFX with a thiopurine derivate or methotrexate. Receives: Other: Switch to SC CT-P13. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) at steady state
AUC is estimated by pharmacokinetic modelling (MW Pharm)
Measured: 30-32 weeks
Secondary outcomes (3)
Quality of life score
Quality of life questionnaire (IBDQ-NL)
Measured: 30-32 weeks
Patient satisfaction
5-points scale
Measured: 30-32 weeks
Time expenditure
quationnaire
Measured: 30-32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start12 Mar 2024
- Primary completion10 Oct 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 and is designed to compare the pharmacokinetics of SC CT-P13 to IV IFX and relate this to the pharmacodynamics.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381518
- Sponsor's protocol ID
- Z2023165
- Acronym
- SHUFFLE
- Status last verified
- Sep 2025
- First submitted
- 12 Mar 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease: Evaluation of Exposure Parameters
- ClinicalTrials.gov ID
- NCT06381518
- Acronym / sponsor ID
- SHUFFLE / Z2023165
- Conditions
- IBD, Infliximab, Crohn Disease, Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 24 Apr 2024 (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.
The aim of this study is to evaluate the IFX exposure (AUC), effectiveness, presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator.
Methods: this is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX (cohort 2). After the switch to SC CT-P13, patients are followed for 24 weeks.
The study is subdivided into two phases: the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch. After enrolment, the subject receives a final dose of IV IFX according to their own maintenance schedule. Primary endpoints are the Area under the concentration-time curve (AUC) at steady state (1) before and after the switch to SC CT-P13 and (2) with or without concomitant immunomodulator during SC therapy. AUCs will be estimated using pharmacokinetic modelling in MwPharm. Besides IFX trough level, treatment related time expenditure, quality-of-life and patient satisfaction will be assessed before and after the switch.
Detailed description
On demand.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 and is designed to compare the pharmacokinetics of SC CT-P13 to IV IFX and relate this to the pharmacodynamics.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Infliximab monotherapy | Other | Other: Switch to SC CT-P13.Adult patients (18-75 years old) on maintenance monotherapy of IV IFX. |
| Cohort 2: infliximab combination therapy | Other | Other: Switch to SC CT-P13.Adult patients on maintenance combination therapy of IV IFX with a thiopurine derivate or methotrexate. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (18-75 years) with an confirmed diagnosis of IBD according to usual criteria, including previous endoscopic examination.
- Patients on IV IFX maintenance therapy at a stable dose and dosing interval for at least 16 weeks of 5-10 mg/kg every 6-8 weeks without side effects of IFX.
- IBD in clinical remission for at least 16 weeks without treatment with systemic corticosteroids in the previous 16 weeks. Clinical remission in adult patients is defined as a Harvey-Bradshaw index (HBI) < 4 for CD [18] or a partial Mayo Index (PMI) <2 for UC [19], with faecal calprotectin levels <250 μg/g faeces and CRP <10 mg/L.
- Concomitant immunomodulators are allowed, i.e. in stable doses were received for at least 12 weeks prior to study enrolment. These doses will be continued throughout the study, including azathioprine (AZA), 6-mercaptopurine (6-MP), tioguanine (TG) and MTX.
- Written informed consent
Key exclusion criteria (9 listed)
- Patient <18 years of age.
- Allergy or hypersensitivity to any of the excipients of SC CT-P13.
- Patient with active perianal fistula.
- Patient with another autoimmune disease in addition to IBD.
- Patient treated concomitantly with another Mab in addition to IFX.
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 |
|---|---|---|
| Switch to SC CT-P13.all patients in the study will switch from IFX to SC CT-P13 | Other | Cohort 1: Infliximab monotherapy, Cohort 2: infliximab combination therapy |
Primary outcome
Area under the curve (AUC) at steady state
Time frame: 30-32 weeks
AUC is estimated by pharmacokinetic modelling (MW Pharm)
3 secondary outcomes
Quality of life score
Time frame: 30-32 weeks
Patient satisfaction
Time frame: 30-32 weeks
Time expenditure
Time frame: 30-32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Switch to SC CT-P13. in people with IBD and Infliximab, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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 9 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: finished, as of the sponsor's last update on 6 Jan 2026. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) at steady state (time frame: 30-32 weeks). 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 6 Jan 2026.