IRCT20150303021315N36 IRCT 2025-03-21 AryoGen Pharmed Company Evaluation of non-inferiority of efficacy and safety of Infliximab (AryoGen) VS Remicade (Janssen) in UC A phase 3, randomized, multicenter, double-blind, two-armed, parallel, active-controlled, Non-inferiority clinical trial to compare efficacy and safety of Infliximab (Infliximab produced by AryoGen Pharmed co) versus Remicade® (Infliximab produced by Janssen Immunology co.) in patients with active moderate to severe Ulcerative Colitis 2025-05-28 anticipated 260 Recruiting https://irct.ir/trial/82366 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization plan of the patients will be carried out centrally using an R-CRAN software version 4.2.1. Blocks (with the size 2 or 4) will be made using permuted block randomization for a total of 260 patients (1:1 allocation ratio). After the randomization procedure, a code will be allocated to each patient that will be used as a patient identifier throughout the study. The assigned code will be denoted by 4 initials (corresponding to the first two letters of the first name, the first two letters of the surname) and three numbers (center code). Moreover, the described code is followed by a study unique identification code consisting of the first three letters of the generic name of the investigational product, respectively (IFX), and three numbers (corresponding to the randomization number), e.g., ABCD001IFX-001. The randomization number will be assigned in a consecutive way, Blinding description: In this double-blind study, subjects and the product administrators are blinded. The size of vials is different. For this purpose, subjects and administrator of the drug will be blinded by considering two nurses in each center: one nurse who opens the drug package and prepares the drug for injection, and another nurse who injects the drugs and will remain blind throughout the study. 3 Ulcerative Colitis. Intervention 1: Intervention group: Infliximab (AryoGen Pharmed co., Iran), 5 mg/kg, intravenous infusion, at day 0 and weeks 2, 6, 14, and 22. Intervention 2: Control group: Remicade® (Infliximab, Janssen Immunology co., Belgium) 5 mg/kg, intravenous infusion, at day 0 and weeks 2, 6, 14, and 22. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information