An Efficacy and Safety Study of GNR-086 (Canakinumab Biosimilar) and Ilaris® in Patients With Adu… (NCT06497491) | Clinical Trial Compass
CompletedPhase 3
An Efficacy and Safety Study of GNR-086 (Canakinumab Biosimilar) and Ilaris® in Patients With Adult-onset Still's Disease
Russia118 participantsStarted 2023-12-12
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Availability of written informed consent obtained from the patient before the start of any procedures related to the study.
* Male and female patients aged 18-75 years, inclusive, at the time of signing the informed consent form.
* Patients with a documented diagnosis of adult Still's disease in accordance with the classification criteria of Yamaguchi M. et al. (J. Rheumatology, 1992) and the duration of the disease is at least 2 months before signing the Informed Consent Form.
* Disease activity ≥2.6 according to DAS28-ESR.
* No change in the dosing regimen of methotrexate (maximum 20 mg/m2/week) or other immunosuppressive agent for at least 6 weeks before randomization and/or no change in the dosing regimen of one nonsteroidal anti-inflammatory drug (NSAID) as treatment for adult Still's disease for at least 14 days before randomization and/or no change in the dosage regimen of the glucocorticosteroid drug for at least 7 days before randomization.
* Negative result of intradermal test with tuberculosis allergen / IGRA test at screening or within 6 months before screening. Patients with missing screening data can only be included in the study if they undergo immunodiagnosis of tuberculosis infection and the result is negative.
* Agreement to adhere to adequate methods of contraception throughout the study and for 3 months after the end of canakinumab therapy.
Exclusion Criteria:
* Diagnosis of macrophage activation syndrome (MAS) within the last 3 mo…
What they're measuring
1
Proportion of patients with a clinically significant (>1.2 points) decrease in the Disease Activity Score-28 for Rheumatoid Arthritis with Erythrocyte Sedimentation Rate (DAS28-ESR)