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IBD Disease Course of Infliximab-naïve IBD Patients Treated With Subcutaneous Infliximab CT-P13 Remsima®

NCT05722353 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-04-02

No results posted yet for this study

Summary

CURRENT STATE OF KNOWLEDGE IN VIEW OF THE RESEARCH About the condition under investigation Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic diseases characterized by relapsing and remitting episodes.

About comparator strategies/procedures Infliximab in its Intravenous (IV) form was the first biotherapy to be approved to treat IBD. Biosimilars of intravenous (IV) infliximab have been shown to be non-inferior to the reference product in patients with IBD, to induce and maintain clinical response

Recently, the subcutaneous (SC) formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) has been shown to be non-inferior on CT-P13 concentration at week 22 to the IV formulation of CT-P13 (CT-P13 IV). These results were based on 66 patients treated with CT-P13 SC, and larger studies are needed to better assess IBD disease course of patients treated with CT-P13 SC in real-life setting.

Conditions

  • Inflammatory Bowel Diseases

Interventions

OTHER

Biocollection

Collection of blood samples and feces specimen at inclusion visit; clinical and biological assessment at each visit.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Julien Kirchgesner · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • France

Study Locations

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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 NCT05722353 on ClinicalTrials.gov