Actively Recruiting
A Multicenter Randomized, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy with Subcutaneous Infliximab and Concomitant Immunosuppression in Moderate to Severe Crohn's Disease
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-12-10
158
Participants Needed
1
Research Sites
26 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
This research aims to compare the effectiveness of subcutaneous infliximab (IFX) with and without immunosuppressive medications in adults with moderate to severe Crohn's disease. The study is designed as a prospective, multicenter, randomized controlled trial to assess whether IFX alone is no worse than IFX combined with immunosuppressants in helping patients achieve corticosteroid-free clinical remission and significant improvement in intestinal inflammation by week 26. Participants will be randomly assigned to one of two groups: one receiving IFX alone via subcutaneous injections and the other receiving IFX along with immunosuppressive drugs such as 6-mercaptopurine or methotrexate. The IFX dosing schedule starts with 240 mg at weeks 0 and 2, followed by 120 mg every two weeks. The combination group will restart immunosuppressive therapy after screening, while the monotherapy group will not receive additional immunosuppression. The treatment period lasts 26 weeks. During the study, patients will undergo assessments including clinical symptom scoring, endoscopy to evaluate intestinal healing, blood and stool tests for inflammation markers, quality of life questionnaires, and drug level monitoring. Researchers will track adverse events and immune responses to IFX. The main outcome is the proportion of patients achieving corticosteroid-free remission and endoscopic improvement at 26 weeks. Participants' progress will be monitored throughout the study duration to evaluate treatment effects and safety.
CONDITIONS
Brief 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 immediate infliximab treatment
- Able to understand and comply with study requirements
- Signed informed consent
- Male or non-pregnant, non-lactating female with no desire to become pregnant in 26 weeks
You will not qualify if you...
- Imminent need of surgery
- Short bowel syndrome, ostomy, or symptomatic non-inflammatory stricture
- Previous exposure to infliximab
- Unacceptable side effects to all immunosuppressants
- Recent treatment with adalimumab, vedolizumab, or ustekinumab
- Primary non-response or intolerance to adalimumab
- Enteric infections detected within 2 weeks prior
- Participation in another interventional trial
- Ulcerative colitis or unclassified inflammatory bowel disease
- Ongoing abdominal or perianal abscess
- History of colon cancer or colonic dysplasia (except removed sporadic adenoma)
- Active or latent tuberculosis unless treated
- Severe cardiac failure
- History of demyelinating disease
- Recent live vaccination within 4 weeks
- Acute or chronic infections except chronic herpes or HPV
- History of cancer in last 5 years except non-melanoma skin cancer
- Male patients with negative Epstein-Barr virus serology
- Alcohol or drug use interfering with study
- Psychiatric problems interfering with study
- Unable to attend all visits
- History of non-compliance with study protocols
- Contraindication for endoscopy
- Use of investigational drug within 30 days or 5 half-lives
- Pregnancy, lactation, or planning pregnancy in 26 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive subcutaneous infliximab either as monotherapy or in combination with immunosuppressive agents to treat moderate to severe Crohn's disease.
Visits at weeks 0, 2, 4, 8, 14, and 26 for treatment administration and assessments
Trial Site Locations
Total: 1 location
1
Amsterdam UMC AMC
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
Research Team
D
Dr. K. Gecse, MD
E
E Clasquin, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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