Treatment with Subcutaneous Infliximab for Crohn's Disease

A Multicenter Randomized, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy with Subcutaneous Infliximab and Concomitant Immunosuppression in the Treatment of Moderate to Severe Crohn's Disease

This study is testing if a new way of giving infliximab can help people with moderate to severe Crohn's disease feel better without needing steroids.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 158 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Drugs / interventions: adalimumab, vedolizumab, ustekinumab, methotrexate, Infliximab, prednisone
• Locations: 1 site (Amsterdam, North Holland)
• Trial ID: NCT06059989 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy of subcutaneous infliximab, with and without immunomodulators, for treating moderate to severe Crohn's disease. It is a multicenter, randomized controlled trial designed to assess the proportion of patients achieving corticosteroid-free clinical remission and endoscopic response after 26 weeks of treatment. The study aims to enroll 158 participants across approximately 20 sites in the Netherlands, focusing on patients who have not responded to or have experienced side effects from previous treatments. Participants will be monitored for their response to the treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe active Crohn's disease and specific disease activity index scores.

Not a fit: Patients who have not been diagnosed with Crohn's disease or those with mild disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with moderate to severe Crohn's disease who have not responded to existing therapies.

How similar studies have performed: Previous studies have shown promise with similar biologic treatments for Crohn's disease, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients 18 years or older diagnosed with Crohn's disease
2. Patients with moderate to severely active Crohn's disease with a Crohn's Disease Activity Index (CDAI) of 250 to 450 and presence of endoscopic ulceration in the terminal ileum, colon or both. Minimal SES-CD is ≥ 6 or ≥ 4 for isolated ileal disease.
3. Patients who had no response or loss of response to or have had intolerable side effects to one or more to the following: glucocorticoids, thiopurines (azathioprine/6-mercaptopurine/6-thioguanin), methotrexate , adalimumab, vedolizumab or ustekinumab OR patients in need of immediate top-down treatment with IFX at the discretion of the treating physician.
4. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
5. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedure.
6. Male or non-pregnant, non-lactating females. No wish to become pregnant in the coming 26 weeks.

Exclusion Criteria:

1. Patients at imminent need of surgery as judged by the treating clinician
2. Patients with the short bowel syndrome, an ostomy or a symptomatic non-inflammatory stricture
3. Patients previously exposed to IFX (intravenous or subcutaneous)
4. Previously unacceptable side effects or intolerance to all immunosuppressants (both thiopurines and methotrexate)
5. Treatment with adalimumab or vedolizumab or ustekinumab within 30 days
6. Patients who have had a primary non-response to adalimumab or had intolerable class-related side effects (as evaluated at the discretion of the treating physician)
7. Enteric pathogens (such as Salmonella, Shigella, Yersinia, Campylobacter and C. difficile) detected by stool analysis within 2 weeks prior to enrollment or at screening
8. Ongoing participation in another interventional trial
9. Patients with Ulcerative Colitis or Inflammatory bowel disease unclassified (IBD-U)
10. Patients with ongoing abdominal or undrained perianal abscess
11. Patients with a history of colon cancer or colonic dysplasia, unless sporadic adenoma, which has been removed
12. Active or latent tuberculosis (screening according to national guidelines). Except when the latter has been treated appropriately according to national guidelines.
13. Cardiac failure in the New York heart Association (NYHA) stage III-IV
14. History of demyelinating disease
15. Recent live vaccination (≤ 4 weeks)
16. Patients with ongoing acute/chronic infection (including but not limited to HIV, hepatitis B and C) with the exception of chronic herpes labialis or cervical human papillomavirus (HPV)
17. History of cancer in the last 5 years with the exception of non-melanoma skin cancer
18. Male patients with Epstein-Barr virus (EBV) negative serology
19. A history of alcohol or illicit drug use that in the opinion of the principal investigator (PI) would interfere with study procedures
20. Patients with psychiatric problems that in the opinion of the PI would interfere with study procedures
21. Patients unable to attend all study visits
22. Patients with a history of non-compliance with clinical study protocols
23. Contraindication for endoscopy
24. Patients who received any investigational drug in the past 30 days or 5 half-lives, whichever is longer
25. Pregnancy or lactation or wish to become pregnant in the coming 26 weeks

Where this trial is running

Amsterdam, North Holland

• Amsterdam UMC AMC — Amsterdam, North Holland, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Dr. K. Gecse, MD

Conditions: Inflammatory Disease, Disease Crohn, Bowel Disease, Crohn's disease, Biological, Subcutaneous