An observational study in IBD - Inflammatory Bowel Disease and RA - Rheumatoid Arthritis, sponsored by Erwin Dreesen. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Erwin Dreesen · Observational
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 would be highly informative. While popPK models of subcutaneous infliximab 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.
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.
This study's planned enrollment of 439 is above the median of 139 across 645 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →This is the only study on the registry with Erwin Dreesen as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients with inflammatory bowel disease
Exclusion Criteria:
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).
Drug: Subcutaneous infliximab CT-P13 Remsima®SC
Subcutaneous infliximab
Dose-exposure-response relationship of subcutaneous infliximab
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.
Time frame: At least 24 weeks
No study locations are listed for this record.
Plan to share: Undecided — The decision that whether or not to share the IPD will depend of the modalities of the data transfer agreement.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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