InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Infliximab subcutaneous
DrugMono and combination therapy group
Immunosuppressive Agents
DrugCombination group only
Treatment groups
158 Participants
are divided into 2 treatment groupsGroup A: MonotherapyExperimental treatment 1 intervention
Group B: Combination therapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Crohn's disease activity index <150 (-10 to 480) AND endoscopic response , where the higher score means worse outcome .
The proportion of patients in corticosteroid-free clinical remission.
Time frame
at week 0 and 26Secondary outcomes
1
Endoscopic remission
The proportion of patients with absence ulcerations larger then 5mm
Time frame
week 0 and 262
Simple Endoscopic score for Crohn's disease ≤2 ( 0-60) where a higher score means worse outcome
Proportion of patients with endoscopic remission
Time frame
week 0 and 263
Crohn's disease activity index <150 (-10 to 480) where a higher score is a worse outcome
Number of patients in clinical remission
Time frame
week 0, 2, 4, 8, 14 and 264
Crohn's disease activity index improved with 70 points (-10 to 480) where a higher score is a worse outcome.
Proportion of patients achieving clinical response
Time frame
week 0, 2, 4, 8, 14 and 26Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Celltrion
Collaborator
Source ClinicalTrials.gov