InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease

ConditionsInflammatory Disease Disease Crohn Bowel Disease

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-80

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

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

Infliximab subcutaneous
Immunosuppressive Agents

Treatment groups

158 Participants

are divided into 2 treatment groups

Locations

Amsterdam UMC AMC1105AZ, AmsterdamNorth Holland, Netherlands

Sponsors and collaborators

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

Lead sponsor

Celltrion

Collaborator

Source ClinicalTrials.gov