Crohn'sUCRecruiting
Subcutaneous Infliximab After A Previous Intravenous Dose Optimization
Phase 4 · Testing Infliximab · 15 sites · Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Infliximab (a drug), Infliximab (a drug) and Infliximab (a drug) as a possible treatment. Condition(s) listed: Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 6 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 275 participants are expected to take part.
- Start date: 2024-04-09.
- Main results expected around 2026-05 (estimate from the record).
- 15 study sites listed (14 marked recruiting) in Belgium.
Main thing being measured
- • The proportion of patients that maintain steroid-free clinical and biological remission by week 52 without treatment optimization after switch to SC infliximab (composite endpoint) (week 52)
In the researchers’ words
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…
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 | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis |
| Lead sponsor | Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW |
| Collaborators | Celltrion |
| Enrollment | 275 (estimated) |
| Start date | 2024-04-09 |
| Primary completion (est.) | 2026-05 |
| First posted | 2023-11-02 |
| Last updated | 2024-07-26 |
| Official title | Subcutaneous Infliximab After A Previous Intravenous Dose Optimization |
| ClinicalTrials.gov ID | NCT06113913 |
Interventions
- Infliximab (Drug)
Weekly administration of subcutaneous infliximab. - Infliximab (Drug)
Bi-weekly administration of subcutaneous infliximab. - Infliximab (Drug)
Optimized dosing schedule of intravenous infliximab.
Full eligibility criteria (from the record)
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
Locations (15)
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair ziekenhuis Antwerpen | Antwerp | Belgium | Recruiting |
| Imeldaziekenhuis | Bonheiden | Belgium | Recruiting |
| AZ Sint-Jan Brugge | Bruges | Belgium | Not yet recruiting |
| Erasme | Brussels | Belgium | Recruiting |
| Ziekenhuis Oost-Limburg | Genk | Belgium | Recruiting |
| AZ Sint-Lucas Gent | Ghent | Belgium | Recruiting |
| Universitair ziekenhuis Gent | Ghent | Belgium | Recruiting |
| Universitair ziekenhuis Leuven | Leuven | Belgium | Recruiting |
| Heilig Hart ziekenhuis Lier | Lier | Belgium | Recruiting |
| CHU Liège - Sart Tilman | Liège | Belgium | Recruiting |
| VITAZ | Sint-Niklaas | Belgium | Recruiting |
| AZ Vesalius | Tongeren | Belgium | Recruiting |
| CHwapi | Tournai | Belgium | Recruiting |
| AZ Maria Middelares | Ghent, Oost-Vlaanderen | Belgium | Recruiting |
| AZ Oostende | Ostend, West-Vlaanderen | Belgium | Recruiting |
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.