Comparison of Complarate® (Tocilizumab Biosimilar) and Actemra® in Patients With Rheumatoid Arthritis
NCT Number: NCT06475508
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Rheumatoid Arthritis
Interventions: BIOLOGICAL: Complarate®|BIOLOGICAL: Actemra®
Sponsor: AO GENERIUM
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 465
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-02-13
Completion Date: 2024-06-11
Locations: Limited Liability Company "Family Clinic No. 4", Korolev, Moscow Region, 141060, Russian Federation|Limited Liability Company Research Medical Complex "Your Health", Kazan, Republic Of Tatarstan, 420097, Russian Federation|State health care institution city clinical hospital №25, Volgograd, Volgograd Region, 400138, Russian Federation|State Budgetary Healthcare Institution Chelyabinsk area Clinical Hospital, Chelyabinsk, 454048, Russian Federation|JSC "TsSM", Ekaterinburg, 620043, Russian Federation|Limited Liability Company "Medical Center "Revma-Med", Kemerovo, 650070, Russian Federation|Limited Liability Company "OLLA-MED", Moscow, 105554, Russian Federation|State Budgetary Healthcare Institution MKSC named after A.S. Loginova Moscow Health Department, Moscow, 111123, Russian Federation|Federal State Budgetary Institution "Research Institute of Rheumatology named after V.A. Nasonova", Moscow, 115522, Russian Federation|Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov Ministry of Health of Russia, Moscow, 119435, Russian Federation|Federal State Budgetary Educational Institution of Higher Education Moscow State University of Medicine and Dentistry, Moscow, 125367, Russian Federation|Federal State Autonomous Educational Institution of Russian National Research Medical University named after. N. I. Pirogova, Moscow, 129226, Russian Federation|Limited Liability Company "Ersi Medical", Novosibirsk, 630005, 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|Medical center, clinic "Medical Technologies", Saint Petersburg, 191025, Russian Federation|Limited Liability Company "Ex Seven Clinical Research", Saint Petersburg, 194156, Russian Federation|Limited Liability Company "Interleukin", Saint Petersburg, 194214, Russian Federation|Limited Liability Company "Strategic Medical Systems", Saint Petersburg, 194291, Russian Federation|State Budgetary Healthcare Institution Leningrad area Clinical Hospital, Saint Petersburg, 194291, Russian Federation|JSC "North-West Center for Evidence-Based Medicine", Saint Petersburg, 194355, Russian Federation|Federal State Budgetary Educational Institution of Higher Education Saratov State Medical University named after. V.I.Razumovsky Ministry of Health of Russia, Saratov, 410054, Russian Federation|Private foundation "RZD-Medicine" Smolensk", Smolensk, 214025, Russian Federation|State Budgetary Healthcare Institution Tula area Clinical Hospital, Tula, 300053, Russian Federation|State Budgetary Healthcare Institution Ulyanovsk area Clinical Hospital, Ulyanovsk, 432063, Russian Federation|Limited Liability Company "CMKI-PRACTIKA", Yaroslavl, 150003, Russian Federation|State Budgetary Healthcare Institution "Clinical Hospital No. 2", Yaroslavl, 150030, Russian Federation|Central City Hospital, Yaroslavl, 150047, Russian Federation

Summary:
This is a randomized double-blind comparative parallel group study of the efficacy and safety of tocilizumab biosimilar Complarate® and Actemra® in the treatment of patients with rheumatoid arthritis with moderate to high disease activity. Participants received an intravenous dose of tocilizumab 8 mg/kg once 4 weeks. The time on study treatment was 24 weeks.

Primary Outcome Measures: Proportion of Participants with an American College of Rheumatology 20% (ACR20) response, The ACR 20 response: greater than or equal to (\>/=) 20 percent (%) improvement in TJC and SJC (28 assessed joints), and 20% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR at week 24, week 24
Secondary Outcome Measures: Proportion of Participants with an American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response, The ACR 20, 50, and 70 responses: greater than or equal to (\>/=) 20 percent (%), 50%, and 70% improvement in TJC and SJC (28 assessed joints), and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR at each visit, week 24|Time to ACR20 response, The ACR 20 response: greater than or equal to (\>/=) 20 percent (%) improvement in TJC and SJC (28 assessed joints), and 20% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR at week 24, week 24|Change in Disease Activity Score Based on 28-Joints Count (DAS28), DAS28 is calculated from the TJC and SJC based on a 28-joint assessment, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hour) and PtGDA assessed on 0-10 cm VAS. Higher scores indicate greater affectation due to disease activity. DAS28-ESR total score= 0-9.4. DAS28-ESR \</=3.2 indicates low disease activity, DAS28-ESR \>3.2 to 5.1 indicates moderate to high disease activity, and DAS28-ESR \</=3.2 indicates remission., 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 the disease activity index (DAS28), DAS28 is calculated from the TJC and SJC based on a 28-joint assessment, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hour) and PtGDA assessed on 0-10 cm VAS. Higher scores indicate greater affectation due to disease activity. DAS28-ESR total score= 0-9.4. DAS28-ESR \</=3.2 indicates low disease activity, DAS28-ESR \>3.2 to 5.1 indicates moderate to high disease activity, and DAS28-ESR \</=3.2 indicates remission., week 24|Change in Simplified Disease Activity Index (SDAI), SDAI is a numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and C-reactive protein (CRP) in milligrams per deciliter (mg/dL). Higher scores indicate greater affectation due to disease activity. SDAI total score = 0-86. SDAI \</=3.3 indicates disease remission, \>3.4 to 11 indicates low disease activity, \>11 to 26 indicates moderate disease activity, and \>26 indicates high disease activity, week 24|Change in Clinical Disease Activity Index (CDAI), CDAI is a numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient's global assessment of disease activity (PtGDA) and physician global assessment of disease activity (PGDA) assessed on 0-10 centimeters (cm) visual analogue scale (VAS). Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score less than or equal to (\</=) 2.8 indicates disease remission, greater than (\>) 2.8 to 10 indicates low disease activity, \>10 to 22 indicates moderate disease activity, and \>22 indicates high disease activity, week 24|Proportion of Participants who achieved remission in accordance with the ACR remission criteria, Criteria for rheumatoid artritis remission (ACR/EULAR criteria, 2011). Simultaneous fulfillment of all conditions No. 1-4: 1. number of painful joints (TJ) ≤1, 2. number of swollen joints (SJ) ≤1, 3. C-reactive protein ≤1 mg/dL, 4. general assessment of the disease by the patient (OZB, according to YOUR) ≤1, OR fulfillment of condition No. 5, regardless of the fulfillment of conditions No. 1-4: 5. SDAI index ≤ 3.3., week 24|Proportion of Participants who dropped out of the study due to insufficient treatment effectiveness, Insufficient of therapy assessed as the lack of effect after 3 months of therapy using the disease activity in rheumatoid arthritis scale (DAS28) index (from less than 2.6 scores in remission to more then 5,1 scores for very active disease), week 24