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Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC

NCT06274294 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-07-31

No results posted yet for this study

Summary

The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care.

The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

CT-P13

Induction treatment.

Sponsors & Collaborators

  • Paris IBD Center

    collaborator OTHER

  • Celltrion HealthCare France

    collaborator INDUSTRY

  • CMC Ambroise Paré

    lead OTHER

Principal Investigators

  • Yoram Bouhnik, PhD.Med. · Paris IBD Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-01-31
Completion
2025-01-31

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 NCT06274294 on ClinicalTrials.gov