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BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in combination with methotrexate in patients with active rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCD-055 | Experimental | Patients in this group will receive BCD-055 in a dose of 3 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 46, Week 54. |
|
| Remicade® | Active Comparator | Patients in this group will receive Remicade® in a dose of 3 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 46, Week 54. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCD-055 | Biological | BCD-055 is infliximab biosimilar |
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| Measure | Description | Time Frame |
|---|---|---|
| Ratio of patients with ACR20 response after 14 weeks of therapy | Ratio of patients who developed a decrease in American College of Rheumatologists (ACR) score by 20% or more after 14 weeks of therapy with study drug | Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of patients with ACR20 response after 30 and 54 weeks of therapy | Ratio of patients who developed a decrease in American College of Rheumatologists (ACR) score by 20% or more after 30 and 54 weeks of therapy with study drug | Week 30, Week 54 |
| Ratio of patients with ACR50 and 70 response after 14, 30 and 54 weeks of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Ivanov, PhD | JSC BIOCAD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institution of Healthcare "9th Municipal Clinical Hospital" | Minsk | Belarus | ||||
| Institution of Healthcare "First Municipal Clinical Hospital" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31292709 | Derived | Lila AM, Mazurov VI, Denisov LN, Nesmeyanova OB, Ilivanova EP, Eremeeva AV, Usacheva JV, Dokukina EA, Chernyaeva EV, Ivanov RA. A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study. Rheumatol Int. 2019 Sep;39(9):1537-1546. doi: 10.1007/s00296-019-04359-9. Epub 2019 Jul 10. |
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| Remicade® | Biological |
|
|
| Methotrexate | Drug | All patients will receive methotrexate in a dose from 10 to 25 mg per week. |
|
| Folic acid | Drug | All patients will receive folic acid in a dose of 5 mg per week. |
|
Ratio of patients who developed a decrease in American College of Rheumatologists (ACR) score by 50% or more and by 70% or more after 14, 30 and 54 weeks of therapy with study drug |
| Week 14, Week 30, Week 54 |
| Ratio of patients with low activity of rheumatoid arthritis according to index DAS28-CRP(4) after 14, 30 and 54 weeks of therapy | Ratio of patients with low activity of rheumatoid arthritis according to index Disease Activity Score 28 - C-reactive protein (DAS28-CRP(4), score 2.6-3.2) after 14, 30 and 54 weeks of therapy. | Week 14, Week 30, Week 54 |
| Ratio of patients with low activity of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy | Ratio of patients with low activity of rheumatoid arthritis according to Clinical Disease Activity Index (CDAI, score 2.9-10.0) after 14, 30 and 54 weeks of therapy. | Week 14, Week 30, Week 54 |
| Ratio of patients with low activity of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy | Ratio of patients with low activity of rheumatoid arthritis according to Simplified Disease Activity Index (SDAI, score 3.4-11.0) after 14, 30 and 54 weeks of therapy. | Week 14, Week 30, Week 54 |
| Ratio of patients with remission of rheumatoid arthritis according to index DAS28 after 14, 30 and 54 weeks of therapy | Ratio of patients with remission of rheumatoid arthritis according to index Disease Activity Score 28 (DAS28, score less than 2.6) after 14, 30 and 54 weeks of therapy. | Week 14, Week 30, Week 54 |
| Ratio of patients with remission of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy | Ratio of patients with remission of rheumatoid arthritis according to Clinical Disease Activity Index (CDAI, score 0.0-2.8) after 14, 30 and 54 weeks of therapy. | Week 14, Week 30, Week 54 |
| Ratio of patients with remission of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy | Ratio of patients with remission of rheumatoid arthritis according to Simplified Disease Activity Index (SDAI, score 0.0-3.3) after 14, 30 and 54 weeks of therapy. | Week 14, Week 30, Week 54 |
| Ratio of patients with remission of rheumatoid arthritis according to ACR-EULAR criteria after 14, 30 and 54 weeks of therapy | Ratio of patients with low activity of rheumatoid arthritis according to American College of Rheumatologists (ACR)/ European league Against Rheumatism (EULAR) after 14, 30 and 54 weeks of therapy. | Week 14, Week 30, Week 54 |
| Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy | Mean score of quality of life as assessed by Short Form-36 (SF-36) at screening and after 14, 30 and 54 weeks of therapy. | Screening, Week 14, Week 30, Week 54 |
| CRP | Dynamics of blood level of C-reactive protein (CRP) | Screening, Week 14, Week 30, Week 54 |
| ESR | Dynamics of Erythrocyte Sedimentation Rate | Screening, Week 14, Week 30, Week 54 |
| Roentgenologic characteristics of abnormal joints after 54 weeks of therapy | Week 54 |
| Frequency of AE/SAE | 54 weeks |
| Frequency of AE 3-4 grade CTCAE | 54 weeks |
| Frequency of early withdrawals due to AE/SAE | 54 weeks |
| Percentage of patients who developed binding and neutralizing antibodies to infliximab | Screening, Week 14, Week 30, Week 54 |
| Minsk |
| Belarus |
| Institution of Healthcare "Ordena Trudovogo Krasnogo Znameni Regional Clinical Hospital" | Minsk | Belarus |
| Institution of Healthcare "Clinical Hospital of Vitebsk Region" | Vitebsk | Belarus |
| Shalby Hospital | Ahmedabad | India |
| Sapthagiri Institute of Medical Sciences and Research Centre | Bangalore | India |
| S.P Medical College & A.G. of Hospitals | Bīkaner | India |
| Apollo Gleneagles Hospital | Kolkata | India |
| Noble Hospital | Pune | India |
| Ruby Hall Clinic | Pune | India |
| Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University" | Barnaul | Russia |
| Federal State Autonomous Educational Institution of Higher Professional Education "Belgorod State National Research University" | Belgorod | Russia |
| State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Hospital" | Chelyabinsk | Russia |
| Regional State Autonomous Institution of Healthcare "Irkutsk Municipal Clinical Hospital No. 1" | Irkutsk | Russia |
| State Autonomous Institution of Healthcare of Kemerovo Region "S. V. Belayev Kemerovo Regional Clinical Hospital" | Kemerovo | Russia |
| Budgetary Institution of Khanty-Mansi Autonomous Region - Yugra "Regional Clinical Hospital" | Khanty-Mansiysk | Russia |
| State Budgetary Institution of Healthcare "Research Institute - S. V. Ochapovskiy Regional Clinical Hospital 1 | Krasnodar | Russia |
| Budgetary Medical Institution "Kursk Regional Clinical Hospital" | Kursk | Russia |
| Federal State Budgetary Scientific Institution "V. A. Nasonova Research Institute of Rheumatology" | Moscow | Russia |
| State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University | Moscow | Russia |
| State Budgetary Institution of Moscow "O. M. Filatov Municipal Clinical Hospital 15" of the Moscow Healthcare Department | Moscow | Russia |
| Private Institution of Healthcare "Railway Clinical Hospital at Nizhniy Novgorod Station of Russian Railways Open-Joint Stock Company" | Nizhny Novgorod | Russia |
| State Budgetary Institution of Healthcare of Nizhniy Novgorod Region "N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital" | Nizhny Novgorod | Russia |
| State Autonomous Healthcare Institution of Novosibirsk Region, Municipal Clinic No 1 | Novosibirsk | Russia |
| Budgetary Institution of Healthcare of Omsk Region "Regional Clinical Hospital" | Omsk | Russia |
| State Budgetary Institution of Healthcare of the Republic of Karelia "V. A. Baranov Republican Hospital" | Petrozavodsk | Russia |
| Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" | Rostov-on-Don | Russia |
| Federal State Budgetary Educational Institution of Higher Education "I. I. Mechnikov North-West State Medical University" | Saint Petersburg | Russia |
| Limited Liability Company Baltic Medicine | Saint Petersburg | Russia |
| Limited Liability Company BioEq | Saint Petersburg | Russia |
| North-Western State Medical University n.a. I.I.Mechnikov | Saint Petersburg | Russia |
| Private Medical Institution Evromedservis | Saint Petersburg | Russia |
| Saint Petersburg State Budgetary Institution of Healthcare "Clinical Rheumatological Hospital 25" | Saint Petersburg | Russia |
| State Budgetary Institution of Healthcare "Leningrad Region Clinical Hospital" | Saint Petersburg | Russia |
| Non-state Healthcare Institution "Road Clinical Hospital at Saratov II Station of Russian Railways Open Joint-Stock Company" | Saratov | Russia |
| State Institution of Healthcare "Regional Clinical Hospital" | Saratov | Russia |
| Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" | Tomsk | Russia |
| State Budgetary Institution of Healthcare of Tyumen Region "Regional Clinical Hospital No. 1" | Tyumen | Russia |
| State Institution of Healthcare "Municipal Clinical Emergency Hospital 25" | Volgograd | Russia |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000706147 | BCD-055 |
| D000069285 | Infliximab |
| D008727 | Methotrexate |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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