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Subcutaneous Infliximab After A Previous Intravenous Dose Optimization

NCT06113913 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2024-07-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Infliximab

Weekly administration of subcutaneous infliximab.

DRUG

Infliximab

Bi-weekly administration of subcutaneous infliximab.

DRUG

Infliximab

Optimized dosing schedule of intravenous infliximab.

Sponsors & Collaborators

  • Celltrion

    collaborator INDUSTRY

  • Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

    lead OTHER

Principal Investigators

  • Tom Holvoet, MD, PhD · Department of Gastroenterology, VITAZ Sint-Niklaas

  • Annick Moens, MD, PhD · Department of Gastroenterology Heilig Hartziekenhuis Lier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-09
Primary Completion
2026-05-31
Completion
2026-11-30

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06113913 on ClinicalTrials.gov