InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a treatment for Crohn's disease, a condition that causes inflammation in the digestive tract. The study will compare two approaches: one group will receive a medication called subcutaneous infliximab alone, while another group will receive the same medication along with an additional immunosuppressant. The main goal is to see how many patients can achieve a state of remission, meaning their symptoms improve significantly and they can stop using corticosteroids, after 26 weeks of treatment.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with moderate to severe Crohn's disease. They should also have tried other treatments without success or experienced side effects. Participants will need to sign consent forms and attend regular check-ups during the study. It's important to note that individuals with certain health issues, such as recent infections or a history of specific cancers, may not qualify. This trial is currently recruiting participants across multiple sites in the Netherlands, and the first enrollments are expected to start soon.

Gender

ALL

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