A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease
- Conditions
- IBD - Inflammatory Bowel DiseaseRA - Rheumatoid Arthritis
- Interventions
- Drug: Subcutaneous infliximab CT-P13 Remsima®SC
- Registration Number
- NCT07120152
- Lead Sponsor
- Vicky Steyfkens
- Brief Summary
A subcutaneous formulation of infliximab CT-P13 (Remsima, Celltrion) has been approved for clinical use in inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) after demonstration of pharmacokinetic (PK) non-inferiority compared to intravenous CT-P13. The added value of the subcutaneous formulation of CT-P13 has been recognized by IBD physician expert, patients and nurses. However, further investigation is needed to select the right patients and timing for switching to the new subcutaneous formulation. Before investing resources into the design and execution of a prospective clinical trial to address these remaining clinical questions and concerns, an in silica simulation study using a population pharmacokinetic-pharmacodynamic (popPK-PD) model of CT-P13 have been developed for both IBD and RA, a popPK-PD model is still awaited. The development of a popPK-PD model would allow us to bridge infliximab exposure and response, and address clinically relevant questions by focussing on therapeutic outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 439
- Patients with Crohns disease with a score on the Crohn's disease activity index between 220 and 450.
- Patients with active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points (Part 2 only)
- Patients who have previously received a biological agent for the treatment of CD and UC and/or a tumor necrosis factor-alpha (TNF)-inhibitor for the treatment of other diseases.
- Patients who have allergies to any of the excipients of infliximab or any other murine and/or human proteins or patients with a hypersensitivity to immunoglobulin products.
- Patients who have a current or past history if infection with HIV, hepatitis B or C(carriers of hepatitis B and C are nit permitted to enrol into the study, but past hepatitis B resolved can be enrolled).
- Patients who have acute infections requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of the study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug.
- Patient who have an indeterminate result for interferon-y release assay (IGRA) or latent tuberculosis (TB) at Screening. For part 2, if IGRA result is indeterminate at Screening, one retest will be possible during the screening. If the repeated IGRA result is negative, the patient can be included in the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with IBD Subcutaneous infliximab CT-P13 Remsima®SC Patients who have active Crohn's disease with a score on the Crohn's disease activity index between 220 and 450 points. Or patient has active Ulcerative colitis defined by a total Mayo score between 6 and 12 points (part 2 only).
- Primary Outcome Measures
Name Time Method Dose-exposure-response relationship of subcutaneous infliximab At least 24 weeks To understand, describe, and predict the dose-exposure relationship of sibcutaneous infliximab in patients with inflammatory bowel diseased based on available data from previous clinical trials.
- Secondary Outcome Measures
Name Time Method