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Study aim
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Assessment of the non-inferiority of Infliximab (AryoGen) to Remicade (Janssen) in terms of efficacy in moderate to severe active UC
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Design
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phase III, randomized, two-armed, double-blind, parallel, active-controlled, non-inferiority clinical trial
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Settings and conduct
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260 Ulcerative colitis patients in multiple centers (Tehran, Shiraz, Mashhad, Isfahan, Sari, Rasht and Bandar-abbas), randomized, double-blind (patient, health-care provider and analyzer)
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
18 to 65 years, moderate to severe active UC with indication for Infliximab therapy, ICF signing
Exclusion criteria:
Diagnosis of acute severe UC, Proctitis, indeterminate colitis, crohn’s disease, colonic obstruction, colonic mucosal dysplasia, adenomatous colonic polyps, TB, hepatitis B/C, HIV, history of toxic megacolon, C.diff, CMV within 30 days, herpes zoster, other autoimmune diseases, moderate to severe HF, active infection, history of severe fixed symptomatic stenosis, malignancy, demyelinating diseases, pregnancy or breast feeding, hypersensitivity, receiving protocol-prohibited treatments, abnormal lab tests, vaccinations, recent treatment with investigational agent, other conditions making subject enrollment inappropriate
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Intervention groups
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Intervention: Infliximab (AryoGen) 5 mg/kg, IV infusion, at day 0 and weeks 2, 6, 14, and 22
Control: Remicade (Janssen) 5 mg/kg, IV infusion, at day 0 and weeks 2, 6, 14, and 22
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Main outcome variables
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Percentage of patients achieving clinical response at week 8