Actively Recruiting
InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-12-10
158
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
C
Celltrion
Collaborating Sponsor
AI-Summary
What this Trial Is About
Study Design: A Prospective Multicenter Randomized Controlled, Open-label Non-inferiority Study to Investigate the Efficacy of Subcutaneous (SC) Infliximab (IFX) with and without Immunomodulators during Induction treatment in Moderate to Severe Crohn's Disease. Primary endpoint: The proportion of patients in corticosteroid-free clinical remission (as defined by a Crohn's disease activity index (CDAI)\<150) and endoscopic response (as defined by a simple endoscopic score for Crohn's disease (SES-CD) drop of at least 50%) at week 26. Accrual and feasibility: This study will enroll 158 subjects at approximately 20 sites in the Netherlands (peripheral and academic hospitals). The estimated enrollment is 0.5 patient/centre/month leading to an inclusion duration of 16 months once all centres are open. The first enrolment is anticipated in Q1 2021. Treatment, dosage and administration: Eligible patients will be randomized to receive SC IFX monotherapy (240mg at week 0 and week 2 and then 120mg every other week (EOW) OR SC IFX (240mg at week 0 and week 2 and then 120mg EOW) in combination with immunosuppression.
CONDITIONS
Official Title
InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older diagnosed with Crohn's disease
- Moderate to severe active Crohn's disease with CDAI 250 to 450 and endoscopic ulceration
- No response or intolerance to certain prior treatments or need for immediate infliximab treatment
- Ability to understand and comply with study requirements
- Signed informed consent
- Male or non-pregnant, non-lactating female with no pregnancy plans for 26 weeks
You will not qualify if you...
- Need for imminent surgery
- Short bowel syndrome, ostomy, or symptomatic non-inflammatory stricture
- Previous exposure to infliximab
- Intolerance to all immunosuppressants
- Treatment with certain drugs within 30 days
- Primary non-response or intolerance to adalimumab
- Recent detection of enteric pathogens
- Participation in another interventional trial
- Ulcerative colitis or unclassified inflammatory bowel disease
- Ongoing abdominal or perianal abscess
- History of colon cancer or dysplasia (except removed sporadic adenoma)
- Active or latent tuberculosis unless treated
- Severe heart failure (NYHA stage III-IV)
- History of demyelinating disease
- Recent live vaccination (within 4 weeks)
- Ongoing acute/chronic infections except certain viral infections
- Cancer history in last 5 years except non-melanoma skin cancer
- Male patients with negative Epstein-Barr virus serology
- History of substance abuse or psychiatric issues interfering with study
- Unable to attend all study visits
- History of non-compliance with clinical protocols
- Contraindication to endoscopy
- Recent investigational drug use
- Pregnancy, lactation, or plans to become pregnant in 26 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam UMC AMC
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
Research Team
D
Dr. K. Gecse, MD
CONTACT
E
E Clasquin, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here