An Efficacy and Safety Study of GNR-086 (Canakinumab Biosimilar) and Ilaris® in Patients With Adult Still's Disease
NCT Number: NCT06497491
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Still's Disease Adult Onset
Interventions: BIOLOGICAL: GNR-086|BIOLOGICAL: Ilaris®
Sponsor: AO GENERIUM
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 148
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-12-15
Completion Date: 2025-12-31
Locations: State budgetary healthcare institution "Chelyabinsk Regional Clinical Hospital", Chelyabinsk, Chelyabinsk Region, 454076, Russian Federation|State health care institution city clinical hospital №25, Volgograd, Volgograd Region, 400138, Russian Federation|Limited Liability Company "Medical Center "Revma-Med", Kemerovo, 650070, Russian Federation|Limited Liability Company "OLLA-MED", Moscow, 105554, Russian Federation|Federal State Budgetary Institution "Research Institute of Rheumatology named after V.A. Nasonova", Moscow, 115522, Russian Federation|State budgetary healthcare institution of the city of Moscow "City Clinical Hospital No. 52 of the Moscow Health Department" (GBUZ "City Clinical Hospital No. 52 DZM"), Moscow, 123182, Russian Federation|Federal State Autonomous Educational Institution of Russian National Research Medical University named after. N. I. Pirogova, Moscow, 129226, Russian Federation|Federal State Autonomous Educational Institution of Russian National Research Medical University named after. N.I. Pirogov Ministry of Health of Russia Separate structural unit "Russian Gerontological Scientific and Clinical Center", Moscow, 129226, Russian Federation|Limited Liability Company "Medical Center "Healthy Family", Novosibirsk, 630099, Russian Federation|Federal State Budgetary Educational Institution of Higher Education Orenburg State Medical University of the Ministry of Health of Russia, Orenburg, 460018, Russian Federation|Limited Liability Company "Medical Technologies" LLC "Medical Technologies", Saint Petersburg, 192148, Russian Federation|Limited Liability Company "Ex Seven Clinical Research", Saint Petersburg, 194156, Russian Federation|Limited Liability Company "Interleukin", Saint Petersburg, 194214, Russian Federation|State Budgetary Healthcare Institution Leningrad area Clinical Hospital, Saint Petersburg, 194291, Russian Federation|Private foundation "RZD-Medicine" Smolensk", Smolensk, 214025, Russian Federation|Limited Liability Company "BioMed", Vladimir, 600005, Russian Federation|State Budgetary Healthcare Institution "Clinical Hospital No. 2", Yaroslavl, 150030, Russian Federation

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 Still's disease adult onset. Participants received a subcutaneous dose of canakinumab 4 mg/kg once 4 weeks. The time on study treatment was 24 weeks.

Primary Outcome Measures: 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), A composite index and takes into account the following items: Tender joint count (number of tender joints; 0-28); swollen joint count (number of swollen joints; 0-28); ESR (mm/h) and Global Health (Patient's Global Assessment of Disease Activity; from 0=best to 100=worst). Thus, given the reliability, validity, and ability of DAS28 to discriminate the severity of joint involvement, this index has been used in other rheumatic diseases characterized by rheumatoid artritis (RA)-like poly-articular involvement. Of note, a DAS28 score \> 5.1 implies active disease, ≤3.2 low disease activity, and \<2.6 remission. Moderate/high disease activity is defined as a DAS28 higher than 3.2., Week 12
Secondary Outcome Measures: Change in DAS28-ESR/C-reactive protein (CRP) score, A composite index and takes into account the following items: Tender joint count (number of tender joints; 0-28); swollen joint count (number of swollen joints; 0-28); ESR (mm/h) / CRP (mg/l) and Global Health (Patient's Global Assessment of Disease Activity; from 0=best to 100=worst). Thus, given the reliability, validity, and ability of DAS28 to discriminate the severity of joint involvement, this index has been used in other rheumatic diseases characterized by RA-like poly-articular involvement., Week 24|Proportion of patients with an American College of Rheumatology score (ACR) 30/50/70/90/100 response without fever associated with the underlying disease during the 7 days preceding the day of assessment, The ACR30/50/70/90/100 response: greater than or equal to (\>/=) 30/50/70/90/100 percent (%) improvement in TJC and SJC (28 assessed joints), and 30/50/70/90/100 % improvement in 3 of the following 5 criteria, respectively: 1) physician's assessment Global Disease Activity (PhGDA), 2) Patients assessment Global Disease Activity (PtGDA), 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR, Week 24|Area under the curve (AUC) of the disease activity rate (ACR), ACR response criteria measure percentage reduction in 68 painful joints, percentage reduction in 66 swollen joints, and percentage improvement in at least three of the following: Patients assessment Global Disease Activity (PtGDA), physician's assessment Global Disease Activity (PhGDA), Patient Pain Assessment , assessment according to the health assessment questionnaire disability index (HAQ-DI), CRP concentration value., Week 24|Proportion of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28, The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 \</=3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to \</=5.1 or change from baseline \>0.6 to \</=1.2 with DAS28 \</=5.1; non-responders: change from baseline \</=0.6 or change from baseline \>0.6 and \</=1.2 with DAS28 \>5.1, Week 24|Area under the curve (AUC) of CRP concentration, CRP values standardized to a normal range, Week 24|Area under the curve (AUC) of ESR, ESR values standardized to a normal range, Week 24|Area under the curve (AUC) of ferritin levels, Ferritin values standardized to a normal range, Week 24|Proportion of patients with no rash within 24 hours before the end of the 1st week of treatment; and within 7 days before all subsequent visits, The absence or presence of skin rash assessed based on physical exam findings including whether it is typical or atypical, Week 24|Proportion of patients with fever associated with the underlying disease during 24 weeks of treatment, Absence of fever associated with the underlying disease during the 7 days preceding the visit day visit was assessed. Fever is defined as an increase in body temperature ≥38.0 °C, Week 24|Proportion of patients who had exacerbations, Increasing disease activity is defined as the appearance of signs of systemic activity, defined as any of the "major" Yamaguchi M. classification criteria (fever \>39°C intermittent for ≥1 week; arthralgias ≥2 weeks; characteristic rash; white blood cells \>10,000 in mm3 (\>80% granulocytes)), as well as an increase in CRP and/or ferritin levels ≥ 3 times normal., Week 24