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NCT06113913 · ClinicalTrials.gov record · last posted 2024-07-26

Subcutaneous Infliximab After A Previous Intravenous Dose Optimization

Study acronym: AMARETTO
StatusRecruiting
PhasePhase 4
Started2024-04-09
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 26, 2024 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
The goal of this clinical trial is to learn about the treatment with subcutaneous infliximab in patients with inflammatory bowel disease (IBD) that were previously treated with an optimized dose of intravenous infliximab. The main question it aims to answer is: \- Is switching to a weekly dose of subcutaneous infliximab (120 mg) associated with a better outcome compared to the standard fortnightly administration of 120 mg subcutaneous infliximab in patients who received an optimized intravenous dosing schedule? Participants will switch from intravenous infliximab to subcutaneous infliximab and will be randomized to the intervention arm (Subcutaneous infliximab weekly) or the interventional comparison arm (subcutaneous infliximab bi-weekly). Participants will follow daily clinical practice in the monitoring for clinical and biological remission. The participants that are willing to switch to subcutaneous infliximab will be compared to a group of participants not willing to switch. These participants will continue to be treated with their optimized intravenous dose of infliximab.

Amendment record 3 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 3 times since 2023-10-27; most recent amendment 2024-07-25. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-07-25
Status change Active, Not Recruiting→Recruitingv3
2024-04-26
Status change Not Yet Recruiting→Active, Not Recruitingv2
Trial Details
NCT Number NCT06113913
Lead Sponsor Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Collaborators: Celltrion
Conditions Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
Enrollment 275 participants
Start Date 2024-04-09
Primary Completion 2026-05 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2024-07-26