Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease (SHUFFLE)

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Ulcerative Colitis; IBD; Infliximab
• Intervention / Treatment: Other: Switch to SC CT-P13.

Detailed Description

On demand.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Sittard, Netherlands
    • Zuyderland Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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]
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort 1: Infliximab monotherapy; Adult patients (18-75 years old) on maintenance monotherapy of IV IFX.	Other: Switch to SC CT-P13.; all patients in the study will switch from IFX to SC CT-P13
Other: Cohort 2: infliximab combination therapy; Adult patients on maintenance combination therapy of IV IFX with a thiopurine derivate or methotrexate.	Other: Switch to SC CT-P13.; all patients in the study will switch from IFX to SC CT-P13

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve (AUC) at steady state	AUC is estimated by pharmacokinetic modelling (MW Pharm)	30-32 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score	Quality of life questionnaire (IBDQ-NL)	30-32 weeks
Patient satisfaction	5-points scale	30-32 weeks
Time expenditure	quationnaire	30-32 weeks

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Actual): October 10, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease
• Other Study ID Numbers: Z2023165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No