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Clinical Trials in France / NCT05722353
Active, not recruiting Not applicable

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

NCT05722353 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2023-02-13
Last updated
2025-04-02

Condition(s) studied

Inflammatory Bowel Diseases

Investigational drug(s) / intervention(s)

Biocollection

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of Crohn's disease or ulcerative colitis (confirmed by clinical evaluation and a combination of endoscopic, histological, radiological, and/or biochemical investigations according to European guidelines) * Starting infliximab as standard of care (originator or biosimilars) * with or without concomitant immunosuppressive agent and/or steroids use at infliximab initiation * Patients agreeing to participate Exclusion Criteria: * Patients not eligible to infliximab according to standard of care screening * Previous exposure to infliximab: originator or biosimilars * Participation in another interventional study * No coverage by the French health insurance

Primary outcome measure(s)

  • Steroids Steroid-free clinical remission defined as Crohn's Disease Activity Index (CDAI) < 150 in patients with CD — week 48
  • Steroids Steroid-free clinical remission defined as Simple clinical colitis activity index (SCCAI) < 3 in patients with UC — week 48

Trial sites (1)

FacilityCityRegionStatus
Saint Antoine Hospital Service de Gastroentérologie et Nutrition Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05722353 on ClinicalTrials.gov ↗ ← All trials in France