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New treatment option for Inflammatory Bowel Diseases
Official title Subcutaneous Infliximab After A Previous Intravenous Dose Optimization
ClinicalTrials.gov ID: NCT06113913
What this study is testing
What is Infliximab?
Infliximab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for inflammatory bowel diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 must be in biological remission at screening defined as a CRP \<10 mg/L and a fecal calprotectin \<250 µg/g.
You likely can't join if
- Male or female ≤ 18 years
- Patients with an ileorectal anastomosis, an ileal pouch-anal anastomosis or an ostomy
- Patients participating in an treatment 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
See the full eligibility 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...
- 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.
- Male or female ≤ 18 years
- Patients with an ileorectal anastomosis, an ileal pouch-anal anastomosis or an ostomy
- Patients participating in an treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Oost-Vlaanderen, Belgium
- Ostend, West-Vlaanderen, Belgium
- Antwerp, Belgium
- Bonheiden, Belgium
- Bruges, Belgium
- Brussels, Belgium
- Genk, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Lier, Belgium
- Liège, Belgium
- Sint-Niklaas, Belgium
- Tongeren, Belgium
- Tournai, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Oost-Vlaanderen, Belgium; Ostend, West-Vlaanderen, Belgium; Antwerp, Belgium; Bonheiden, Belgium; Bruges, Belgium; Brussels, Belgium and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.