Tests subcutaneous infliximab alone or with immunosuppressants for Crohn's disease

Trial details

Who runs it

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

Trial code

NCT06059989EU 2024-517171-20-00

Record updated

10 December 2024

Original description

Study Design:Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Patients at imminent need of surgery as judged by the treating clinician; 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; Enteric pathogens (such as Salmonella, Shigella, Yersinia, Campylobacter and C. difficile) detected by stool analysis within 2 weeks prior to enrollment or at screening; Patients who received any investigational drug in the past 30 days or 5 half-lives, whichever is longer; Patients with the short bowel syndrome, an ostomy or a symptomatic non-inflammatory stricture; Patients with Ulcerative Colitis or Inflammatory bowel disease unclassified (IBD-U); 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; 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; 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 with a history of non-compliance with clinical study protocols; 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); Ongoing participation in another interventional trial; Patients with ongoing abdominal or undrained perianal abscess; Recent live vaccination (≤ 4 weeks); Male patients with Epstein-Barr virus (EBV) negative serology; Patients unable to attend all study visits; Contraindication for endoscopy; Pregnancy or lactation or wish to become pregnant in the coming 26 weeks.

ClinicalTrials.gov NCT06059989 · EU CTIS 2024-517171-20-00