Trial Details

Not Recruiting
Basic Information
Clinical ID c2107
Identifier CTIS2023-508584-72-00
Trial Title Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients with Active Crohn's Disease or Ulcerative Colitis - 2023/12
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Immune Bowel Disease (including Crohn's disease and Ulcerative colitis). MedDRA version: 20.0Level: PTClassification code: 10009900Term: Colitis ulcerative Class: 100000004856 MedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Interventions Product Name: Remsima 100 mg powder for concentrate for solution for infusion, Product Code:PRD2620218, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: Remsima 100 mg powder for concentrate for solution for infusion, Product Code:PRD2620248, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: Remsima 120 mg solution for injection in pre-filled syringe, Product Code:PRD7753572, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength:
Participant Information
Sponsor Centre Medico Chirurgical Ambroise Pare Hartmann
City -
Country/Region France
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, OLDER_ADULT
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE3
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -