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First received: July 05, 2024

Clinical Trial: An Efficacy and Safety Study of GNR-086 (Canakinumab Biosimilar) and Ilaris® in Patients With Adult-onset Still's Disease

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Still's Disease Adult Onset

Study Type: INTERVENTIONAL


Official Title: A Single-blind Randomized Study of the Efficacy and Safety of the GNR-086 (Canakinumab Proposed Biosimilar) in Comparison With the Ilaris®, Conducted in Parallel Groups of Patients With Adult-onset St

Brief Summary: This is a randomized single-blind comparative parallel group study of the efficacy and safety of canakinumab biosimilar GNR-086 (JSC "GENERIUM", Russia) and Ilaris® (Novartis Pharma Stein AG, Switzerland) in the treatment of patients with adult-onset Still's disease.Participants will receive a subcutaneous canakinumab 4 mg/kg every 4 weeks.The treatment duration is 24 weeks following with the study extension.

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