Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT02762838
- Lead Sponsor
- Biocad
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 426
- Signed informed consent
- Active rheumatoid arthritis according to criteria of American College of Rheumatologists (2010), that was diagnosed at least 6 months prior to screening.
- Active rheumatoid arthritis at screening despite of therapy with methotrexate for 3 last months.
- Use of methotrexate in stable dose for at least 4 weeks before screening (10-25 mg per week).
- History of ineffective treatment with basic antiinflammatory drugs (including methotrexate).
- Previous therapy of rheumatoid arthritis with monoclonal antibodies (including anti-tumor necrosis factor drugs)
- Felty's syndrome
- Functional status - class IV according to ACR classification (1991)
- Low activity of rheumatoid arthritis (DAS28-CRP(4) index less than 3.2)
- Patient needs corticosteroids in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent.
- Patients needs equal of less than 10 mg prednisolone but the dose was not stable for last 4 weeks prior to infliximab treatment
- Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization.
- Prior use of alkylating agents for up to 12 months prior to signing informed consent.
- Intraarticular use of corticosteroids for up to 4 weeks before randomization.
- Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.
- Diagnosis of tuberculosis.
- Body mass more than 130 kg.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remicade® Remicade® 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. Remicade® Methotrexate 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. Remicade® Folic acid 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. BCD-055 BCD-055 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. BCD-055 Methotrexate 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. BCD-055 Folic acid 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.
- Primary Outcome Measures
Name Time Method Ratio of patients with ACR20 response after 14 weeks of therapy Week 14 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
- Secondary Outcome Measures
Name Time Method Ratio of patients with ACR20 response after 30 and 54 weeks of therapy Week 30, Week 54 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
Ratio of patients with ACR50 and 70 response after 14, 30 and 54 weeks of therapy Week 14, Week 30, Week 54 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
Ratio of patients with low activity of rheumatoid arthritis according to index DAS28-CRP(4) 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 Disease Activity Score 28 - C-reactive protein (DAS28-CRP(4), score 2.6-3.2) after 14, 30 and 54 weeks of therapy.
Ratio of patients with low activity of rheumatoid arthritis according to index CDAI 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 Clinical Disease Activity Index (CDAI, score 2.9-10.0) after 14, 30 and 54 weeks of therapy.
Ratio of patients with low activity of rheumatoid arthritis according to index SDAI 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 Simplified Disease Activity Index (SDAI, score 3.4-11.0) after 14, 30 and 54 weeks of therapy.
Ratio of patients with remission of rheumatoid arthritis according to index DAS28 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 Disease Activity Score 28 (DAS28, score less than 2.6) after 14, 30 and 54 weeks of therapy.
Ratio of patients with remission of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy Week 14, Week 30, Week 54 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.
Ratio of patients with remission of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy Week 14, Week 30, Week 54 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.
Ratio of patients with remission of rheumatoid arthritis according to ACR-EULAR criteria 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 American College of Rheumatologists (ACR)/ European league Against Rheumatism (EULAR) after 14, 30 and 54 weeks of therapy.
Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy Screening, Week 14, Week 30, Week 54 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.
CRP Screening, Week 14, Week 30, Week 54 Dynamics of blood level of C-reactive protein (CRP)
ESR Screening, Week 14, Week 30, Week 54 Dynamics of Erythrocyte Sedimentation Rate
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
Trial Locations
- Locations (39)
Institution of Healthcare "First Municipal Clinical Hospital"
🇧🇾Minsk, Belarus
S.P Medical College & A.G. of Hospitals
🇮🇳Bīkaner, India
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
Noble Hospital
🇮🇳Pune, India
State Autonomous Institution of Healthcare of Kemerovo Region "S. V. Belayev Kemerovo Regional Clinical Hospital"
🇷🇺Kemerovo, Russian Federation
Apollo Gleneagles Hospital
🇮🇳Kolkata, India
Federal State Budgetary Scientific Institution "V. A. Nasonova Research Institute of Rheumatology"
🇷🇺Moscow, Russian Federation
State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
🇷🇺Moscow, Russian Federation
Non-state Healthcare Institution "Road Clinical Hospital at Saratov II Station of Russian Railways Open Joint-Stock Company"
🇷🇺Saratov, Russian Federation
State Institution of Healthcare "Regional Clinical Hospital"
🇷🇺Saratov, Russian Federation
Regional State Autonomous Institution of Healthcare "Irkutsk Municipal Clinical Hospital No. 1"
🇷🇺Irkutsk, Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University"
🇷🇺Barnaul, Russian Federation
State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Hospital"
🇷🇺Chelyabinsk, Russian Federation
State Autonomous Healthcare Institution of Novosibirsk Region, Municipal Clinic No 1
🇷🇺Novosibirsk, Russian Federation
Budgetary Institution of Khanty-Mansi Autonomous Region - Yugra "Regional Clinical Hospital"
🇷🇺Khanty-Mansiysk, Russian Federation
Budgetary Institution of Healthcare of Omsk Region "Regional Clinical Hospital"
🇷🇺Omsk, Russian Federation
State Budgetary Institution of Healthcare of the Republic of Karelia "V. A. Baranov Republican Hospital"
🇷🇺Petrozavodsk, Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"
🇷🇺Rostov-on-Don, Russian Federation
State Budgetary Institution of Healthcare "Leningrad Region Clinical Hospital"
🇷🇺Saint Petersburg, Russian Federation
State Institution of Healthcare "Municipal Clinical Emergency Hospital 25"
🇷🇺Volgograd, Russian Federation
Institution of Healthcare "9th Municipal Clinical Hospital"
🇧🇾Minsk, Belarus
Sapthagiri Institute of Medical Sciences and Research Centre
🇮🇳Bangalore, India
State Budgetary Institution of Healthcare "Research Institute - S. V. Ochapovskiy Regional Clinical Hospital 1
🇷🇺Krasnodar, Russian Federation
Budgetary Medical Institution "Kursk Regional Clinical Hospital"
🇷🇺Kursk, Russian Federation
Private Institution of Healthcare "Railway Clinical Hospital at Nizhniy Novgorod Station of Russian Railways Open-Joint Stock Company"
🇷🇺Nizhny Novgorod, Russian Federation
State Budgetary Institution of Healthcare of Nizhniy Novgorod Region "N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital"
🇷🇺Nizhny Novgorod, Russian Federation
Federal State Budgetary Educational Institution of Higher Education "I. I. Mechnikov North-West State Medical University"
🇷🇺Saint Petersburg, Russian Federation
Limited Liability Company Baltic Medicine
🇷🇺Saint Petersburg, Russian Federation
Limited Liability Company BioEq
🇷🇺Saint Petersburg, Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University"
🇷🇺Tomsk, Russian Federation
Private Medical Institution Evromedservis
🇷🇺Saint Petersburg, Russian Federation
North-Western State Medical University n.a. I.I.Mechnikov
🇷🇺St.Petersburg, Russian Federation
State Budgetary Institution of Healthcare of Tyumen Region "Regional Clinical Hospital No. 1"
🇷🇺Tyumen, Russian Federation
Federal State Autonomous Educational Institution of Higher Professional Education "Belgorod State National Research University"
🇷🇺Belgorod, Russian Federation
Saint Petersburg State Budgetary Institution of Healthcare "Clinical Rheumatological Hospital 25"
🇷🇺Saint Petersburg, Russian Federation
State Budgetary Institution of Moscow "O. M. Filatov Municipal Clinical Hospital 15" of the Moscow Healthcare Department
🇷🇺Moscow, Russian Federation
Ruby Hall Clinic
🇮🇳Pune, India