InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease

Recruiting now · Phase 3

Conditions studied: Inflammatory Disease, Disease Crohn, Bowel Disease

In brief

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.

Key facts

Study ID

NCT06059989

Run by

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

People needed

158

Starts

2021-11-25

Expected to finish

2025-12-01

Last updated by the study team

2024-12-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 years or older diagnosed with Crohn's disease
• 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.
• 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.
• In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
• The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedure.
• Male or non-pregnant, non-lactating females. No wish to become pregnant in the coming 26 weeks.

You may not qualify if…

• Patients at imminent need of surgery as judged by the treating clinician
• Patients with the short bowel syndrome, an ostomy or a symptomatic non-inflammatory stricture
• Patients previously exposed to IFX (intravenous or subcutaneous)
• Previously unacceptable side effects or intolerance to all immunosuppressants (both thiopurines and methotrexate)
• Treatment with adalimumab or vedolizumab or ustekinumab within 30 days
• 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)
• Enteric pathogens (such as Salmonella, Shigella, Yersinia, Campylobacter and C. difficile) detected by stool analysis within 2 weeks prior to enrollment or at screening
• Ongoing participation in another interventional trial
• Patients with Ulcerative Colitis or Inflammatory bowel disease unclassified (IBD-U)
• Patients with ongoing abdominal or undrained perianal abscess
• Patients with a history of colon cancer or colonic dysplasia, unless sporadic adenoma, which has been removed
• Active or latent tuberculosis (screening according to national guidelines). Except when the latter has been treated appropriately according to national guidelines.
• Cardiac failure in the New York heart Association (NYHA) stage III-IV
• History of demyelinating disease
• Recent live vaccination (≤ 4 weeks)
• 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)
• History of cancer in the last 5 years with the exception of non-melanoma skin cancer
• Male patients with Epstein-Barr virus (EBV) negative serology
• A history of alcohol or illicit drug use that in the opinion of the principal investigator (PI) would interfere with study procedures
• Patients with psychiatric problems that in the opinion of the PI would interfere with study procedures
• Patients unable to attend all study visits
• Patients with a history of non-compliance with clinical study protocols
• Contraindication for endoscopy
• Patients who received any investigational drug in the past 30 days or 5 half-lives, whichever is longer
• Pregnancy or lactation or wish to become pregnant in the coming 26 weeks

Where it is running

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

Full record on ClinicalTrials.gov

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