NCT06113913RecruitingPhase 4
Subcutaneous Infliximab After A Previous Intravenous Dose Optimization
Source: ClinicalTrials.gov · Last updated 26 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 275 (estimated)
- First submitted
- 11 Sept 2023
- Start date
- 9 Apr 2024
- Primary completion date
- May 2026
- Lead sponsor
- Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06113913
- EU CT number
- 2023-508166-15-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 275
- From 9 Apr 2024 to the primary completion date, May 2026
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously treated with SC infliximab
Other illness
- Patients with active perianal fistulizing disease
Age
- Male or female ≤ 18 years
Other
- 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 with microscopic colitis
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Onze-Lieve-Vrouwziekenhuis Coordinator of this site? Confirm its status | Aalst | Belgium | Active, not recruiting |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Active, not recruiting |
| Ziekenhuis Aan De Stroom Coordinator of this site? Confirm its status | Antwerp | Belgium | Active, not recruiting |
| Imelda Coordinator of this site? Confirm its status | Bonheiden | Belgium | Active, not recruiting |
| Az St-Jan Brugge-Oostende A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Active, not recruiting |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Active, not recruiting |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Active, not recruiting |
| AZ Sint-Lucas & Volkskliniek Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| CHU de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| Heilig-Hartziekenhuis Lier Coordinator of this site? Confirm its status | Lier | Belgium | Active, not recruiting |
| Algemeen Ziekenhuis Damiaan Oostende Coordinator of this site? Confirm its status | Ostend | Belgium | Active, not recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Active, not recruiting |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Active, not recruiting |
| AZ Vesalius Coordinator of this site? Confirm its status | Tongeren | Belgium | Active, not recruiting |
| centre Hospitalier de Wallonie Picarde Coordinator of this site? Confirm its status | Tournai | Belgium | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.