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

Inclusion criteria:

18–65 years Moderate to severe active UC ICF signing

Exclusion criteria:

Active/latent TB serious allergies to the formulation Hepatitis B/C or HIV Recent gastrointestinal surgery indeterminate colitis or Crohn Receiving biologics and JAK inhibitors Tacrolimus and Cyclosporine within 4weeks Proctitis ASUC that requires hospitalization Severe fixed symptomatic stenosis of intestine Colonic obstruction or history of that within 6months Having or history of colonic mucosal dysplasia Adenomatous colonic polyps Malignancy within 5years Toxic megacolon C.diff within 60days History or diagnosis of CMV Receiving IV corticosteroids within 14days Herpes zoster within 8 weeks History of demyelinating diseases Diagnosis of other autoimmune-diseases Severe HF class III/IV Abnormalities in laboratory data Receiving live/attenuated vaccine less than 4weeks or planning to receive them Pregnancy/ breastfeeding or planning to pregnancy in study Active infection or history of hospitalization or receiving IV antibiotics within 8weeks or oral within 2weeks Other disease or disorder which put the subject at risk Treatment with any investigational agent in the past 4 weeks or passing less than five half-lives of agent

Target sample size: 260