IBD (general)Not yet recruiting
A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease
Observational · No treatment assigned · Sites not listed yet · Erwin Dreesen
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: IBD - Inflammatory Bowel Disease and RA - Rheumatoid Arthritis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 55
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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)
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 439 participants are expected to take part.
- Start date: 2025-09-01 (planned).
- Main results expected around 2026-09-01 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Dose-exposure-response relationship of subcutaneous infliximab (At least 24 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | IBD - Inflammatory Bowel Disease; RA - Rheumatoid Arthritis |
| Lead sponsor | Erwin Dreesen |
| Collaborators | San Raffaele University Hospital, Italy; University of Liverpool; Hospital Universitario La Fe; University of Southampton; Samsung Medical Center |
| Enrollment | 439 (estimated) |
| Start date | 2025-09-01 |
| Primary completion (est.) | 2026-09-01 |
| First posted | 2025-08-13 |
| Last updated | 2025-09-03 |
| Official title | A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT07120152 |
Interventions
- Subcutaneous infliximab CT-P13 Remsima®SC (Drug)
Subcutaneous infliximab
Full eligibility criteria (from the record)
Inclusion Criteria: * 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) Exclusion Criteria: * Patients who have previously received a biological agent for the treatment of CD and UC and/or a tumor necrosis factor-alpha (TNFa)-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 of infection with HIV, hepatitis B or C (carriers of hepatitis B and C are not 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 the Screening, one retest will be possible during the screening. If the repeated IGRA result is negative, the patient can be included in the study.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.