Actively Recruiting
Subcutaneous Infliximab After A Previous Intravenous Dose Optimization
Led by Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW · Updated on 2024-07-26
275
Participants Needed
15
Research Sites
133 weeks
Total Duration
On this page
Sponsors
B
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Lead Sponsor
C
Celltrion
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Subcutaneous Infliximab After A Previous Intravenous Dose Optimization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained before screening
- Diagnosis of Crohn's disease, ulcerative colitis, or unclassified IBD confirmed by clinical, endoscopic, histological, or radiological criteria
- Male or female aged 18 years or older
- In steroid-free clinical remission at screening with specific symptom scores
- In biological remission at screening with CRP <10 mg/L and fecal calprotectin <250 �b5g/g
- Receiving intravenous infliximab for at least 26 consecutive weeks
- On a stable intravenous infliximab dosing schedule for at least 20 weeks
- Average intravenous infliximab dose per 8 weeks between more than 8 mg/kg and up to 22 mg/kg
- Able to speak and read Dutch, French, or English fluently
You will not qualify if you...
- Age 18 years or younger
- Presence of ileorectal anastomosis, ileal pouch-anal anastomosis, or ostomy
- Participation in another interventional clinical trial with an investigational drug or device
- Previous treatment with subcutaneous infliximab
- Active perianal fistulizing disease
- Microscopic colitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
Actively Recruiting
2
AZ Oostende
Ostend, West-Vlaanderen, Belgium
Actively Recruiting
3
Universitair ziekenhuis Antwerpen
Antwerp, Belgium
Actively Recruiting
4
Imeldaziekenhuis
Bonheiden, Belgium
Actively Recruiting
5
AZ Sint-Jan Brugge
Bruges, Belgium
Not Yet Recruiting
6
Erasme
Brussels, Belgium
Actively Recruiting
7
Ziekenhuis Oost-Limburg
Genk, Belgium
Actively Recruiting
8
AZ Sint-Lucas Gent
Ghent, Belgium
Actively Recruiting
9
Universitair ziekenhuis Gent
Ghent, Belgium
Actively Recruiting
10
Universitair ziekenhuis Leuven
Leuven, Belgium
Actively Recruiting
11
Heilig Hart ziekenhuis Lier
Lier, Belgium
Actively Recruiting
12
CHU Liège - Sart Tilman
Liège, Belgium
Actively Recruiting
13
VITAZ
Sint-Niklaas, Belgium
Actively Recruiting
14
AZ Vesalius
Tongeren, Belgium
Actively Recruiting
15
CHwapi
Tournai, Belgium
Actively Recruiting
Research Team
I
Ingrid Arijs, Phd
CONTACT
J
Jolien De Rechter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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