Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Subcutaneous Infliximab After A Previous Intravenous Dose Optimization

Q: Who can participate in NCT06113913?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06113913?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Subcutaneous Infliximab After A Previous Intravenous Dose Optimization (NCT06113913) is a Phase 4 interventional studying Inflammatory Bowel Diseases and Crohn Disease, sponsored by Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The goal of this clinical trial is to learn about the treatment with subcutaneous infliximab in patients with inflammatory bowel disease (IBD) that were previously treated with an optimized dose of intravenous infliximab. The main question it aims to answer is: \- Is switching to a weekly dose of subcutaneous infliximab (120 mg) associated with a better outcome compared to the standard fortnightly administration of 120 mg subcutaneous infliximab in patients who received an optimized intravenous dosing schedule? Participants will switch from intravenous infliximab to subcutaneous infliximab and will be randomized to the intervention arm (Subcutaneous infliximab weekly) or the interventional comparison arm (subcutaneous infliximab bi-weekly). Participants will follow daily clinical practice in the monitoring for clinical and biological remission. The participants that are willing to switch to subcutaneous infliximab will be compared to a group of participants not willing to switch. These participants will continue to be treated with their optimized intravenous dose of infliximab.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 275 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Inflammatory Bowel Diseases subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Voluntary written willing to sign a consent form of the participant or their legally authorized representative has been obtained prior to any Screening procedures. - Patients with a previously documented CD, UC, IBDU diagnosis confirmed by clinical, endoscopic, histological, and/or radiological criteria - Males and females ≥18 years old. - Patients must be in steroid-free clinical remission at Screening defined as a rectal bleeding score of 0 and a stool frequency score of ≤1 for patients with UC / IBDU, or an average daily abdominal pain score ≤1 and a liquid stool frequency score ≤2.8 for patients with CD (based on the 3 days before the screening visit, excluding the day of or the day before an eventual endoscopy with bowel preparation) and this without the need for any type of steroids in the previous eight weeks. - Patients must be in biological remission at screening defined as a CRP \<10 mg/L and a fecal calprotectin \<250 µg/g. - Patients receiving IV infliximab for at least 26 consecutive weeks. - Patients receiving a stable IV infliximab dosing schedule for at least 20 weeks. - Patients receiving an average IV infliximab dose per 8 weeks based on the two most recent IV administration of more than 8 mg/kg, but not more than 22 mg/kg - Patients who speak and read fluently Dutch, French or English. Who Should NOT Join This Trial: - Male or female ≤ 18 years - Patients with an ileorectal anastomosis, an ileal pouch-anal anastomosis or an ostomy - Patients participating in an interventional clinical trial with an Investigational Medicinal Product (IMP) or device - Patients previously treated with SC infliximab - Patients with active perianal fistulizing disease - Patients with microscopic colitis Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any Screening procedures. * Patients with a previously documented CD, UC, IBDU diagnosis confirmed by clinical, endoscopic, histological, and/or radiological criteria * Males and females ≥18 years old. * Patients must be in steroid-free clinical remission at Screening defined as a rectal bleeding score of 0 and a stool frequency score of ≤1 for patients with UC / IBDU, or an average daily abdominal pain score ≤1 and a liquid stool frequency score ≤2.8 for patients with CD (based on the 3 days before the screening visit, excluding the day of or the day before an eventual endoscopy with bowel preparation) and this without the need for any type of steroids in the previous eight weeks. * Patients must be in biological remission at screening defined as a CRP \<10 mg/L and a fecal calprotectin \<250 µg/g. * Patients receiving IV infliximab for at least 26 consecutive weeks. * Patients receiving a stable IV infliximab dosing schedule for at least 20 weeks. * Patients receiving an average IV infliximab dose per 8 weeks based on the two most recent IV administration of more than 8 mg/kg, but not more than 22 mg/kg * Patients who speak and read fluently Dutch, French or English. Exclusion Criteria: * Male or female ≤ 18 years * Patients with an ileorectal anastomosis, an ileal pouch-anal anastomosis or an ostomy * Patients participating in an interventional clinical trial with an Investigational Medicinal Product (IMP) or device * Patients previously treated with SC infliximab * Patients with active perianal fistulizing disease * Patients with microscopic colitis

Treatments Being Tested

DRUG

Infliximab

Weekly administration of subcutaneous infliximab.

DRUG

Infliximab

Bi-weekly administration of subcutaneous infliximab.

DRUG

Infliximab

Optimized dosing schedule of intravenous infliximab.

Locations (15)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

AZ Maria Middelares

Ghent, Oost-Vlaanderen, Belgium

AZ Oostende

Ostend, West-Vlaanderen, Belgium

Universitair ziekenhuis Antwerpen

Antwerp, Belgium

Imeldaziekenhuis

Bonheiden, Belgium

AZ Sint-Jan Brugge

Bruges, Belgium

Erasme

Brussels, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

AZ Sint-Lucas Gent

Ghent, Belgium

Universitair ziekenhuis Gent

Ghent, Belgium

Universitair ziekenhuis Leuven

Leuven, Belgium

Heilig Hart ziekenhuis Lier

Lier, Belgium

CHU Liège - Sart Tilman

Liège, Belgium

VITAZ

Sint-Niklaas, Belgium

AZ Vesalius

Tongeren, Belgium

CHwapi

Tournai, Belgium

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06113913), the sponsor (Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06113913 clinical trial studying?

Who can participate in NCT06113913?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06113913?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06113913. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06113913. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.