Health Condition 1: null- Patients with diagnosis of active rheumatoid arthritis
Conditions
Interventions
Intervention1: BCD-055-3(Infliximab manufactured by CJSC BIOCAD Russia): In the study, after signing the Informed Consent and completing screening procedures, patients will be stratified and randomly
Visits 4, 5, 6, 7, 8, 9)
Control Intervention1: Remicade® (Schering-Plough (Brinny) Company, Ireland): In the study, after signing the Informed Consent and completing screening procedures, patients w
Visits 4, 5, 6, 7, 8, 9).
Sponsors
BIOCAD INDIA PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed informed consent to participate in the study; 2. Men and women aged 18-75 years inclusive; 3. Confirmed diagnosis of rheumatoid arthritis according to ACR criteria 2010 set at least 6 months prior to screening; 4. Active rheumatoid arthritis at the time of screening despite methotrexate therapy which lasted for the past 3 months; 5. The use of methotrexate in a stable dose for the past 4 weeks prior to the screening period (15-25 mg range per week); 6. Ineffectiveness of previous therapy by disease-modifying antirheumatic drugs (including methotrexate); 7. Consent of a patient with preserved childbearing potential during the period of study to use reliable methods of contraception40 from the date of IC signature and up to 8 weeks after the last dose of study drug/comparator; 8. Adequate kidney and liver function determined at screening under the following parameters: a. Serum creatinine 75 ml/min; b. ALT level c. AST level 9. Absence of clinically significant abnormalities in complete blood count conducted at screening, determined as: a. Hemoglobin level >=120 g/l for males and >=100 g/l for females; b. White blood cell count >=3.5 Ã? 109/l; c. Absolute neutrophil count >=1.5 Ã? 109/l; d. Platelet count >=100 Ã? 109 platelets/l. 10. Ability of the patient to follow the protocol procedures, according to the investigator.
Exclusion criteria
Exclusion criteria: 1. Prior use of any products based on monoclonal antibodies (including tumor necrosis factor alpha inhibitors) for the treatment of rheumatoid arthritis; 2. Feltyâ??s syndrome (irrespectively to clinical form); 3. Functional status of the patient - Class IV according to ACR 1991 classification; 4. Low activity of rheumatoid arthritis (according to DAS28-CRP(4) index of less than 3.2 points); 5. The use of the following medicinal products as concomitan therapy The need for administration of prednisolone or its equivalent in a dose of more than 10 mg orally daily; a. The need for oral administration of prednisone or its equivalent in a dose of b. The use of other disease-modifying antirheumatic drugs besides methotrexate, including hydroxychloroquine, chloroquine, sulfasalazine within 4 weeks prior to screening. If a patient took leflunomide, his screening period should be extended to 12 weeks during which leflunomide administration is prohibited (washout period); c. Acceptance of alkylating agents at any time during 12 months before screening; d. Intra-articular administration of corticosteroids for less than 4 weeks prior to randomization; e. Vaccination with live or attenuated vaccines at any time during the 8 weeks prior to screening. 6. Determined hypersensitivity to murine proteins or any components of the study drugs, methotrexate, folic acid, as well as the drugs being a part of premedication; 7. Hepatitis B, active hepatitis C, HIV, syphilis; 8. Determined diagnosis of tuberculosis; 9. Latent tuberculosis (positive Diaskintest®/PPD test with 5TU/QuantiFERON®-TB Gold test in the absence of pulmonary tuberculosis in the chest radiography). It is permitted to include the patients with suspicious Diaskintest®/PPD test with 5TU/QuantiFERON®-TB Gold test result after consulting with a phthisiatrician who confirmed that latent tuberculosis is absent in this patient; 10. The established diagnosis of other acute or severe chronic infection (sepsis, abscesses, invasive mycoses, histoplasmosis) at screening or in history; 11. Patients with the diagnosed bacterial infection that required oral administration of antibacterial drugs during the two weeks preceding the time of signing the informed consent; patients with the diagnosed bacterial infection that required parenteral administration of antibacterial drugs during four weeks prior to screening; 12. Patients with the established diagnosis of herpes zoster; 13. Drug abuse, alcoholism (including history); 14. Other documented diseases that increase the risk of adverse events in a patient during the study treatment or that mayaffect the assessment of symptoms of the underlying disease; mask, increase, modify the symptoms of the underlying disease or cause clinical, laboratory and instrumental symptoms similar to those of rheumatoid arthritis 15. Body mass of more than 130 kg; 16. Pregnancy, pregnancy planning less than 8 weeks after the end of participation in the study, breastfeeding. 17. Simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 3 months before this study initiation; previous participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with rheumatoid arthritis in each group who achieve improvement in disease according to ACR20 at Week 14 from the time of the first infliximab infusion.Timepoint: Week 14 from the time of the first infliximab infusion according to ACR20 criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation; Safety evaluation; Immunogenicity evaluation; PK evaluation;Timepoint: 1. At Weeks 30 and 54 from the time of the first infliximab infusion according to ACR20 criteria 2.At Weeks 14, 30 and 54 from the time of the first infliximab infusion according to ACR50/70 Criteria 3.Quality of life of patients before the therapy in 14, 30 and 54 weeks after the therapy according to SF36 survey | — |
Countries
India, Russian Federation
Contacts
Public ContactDr Mrutyunjaya Ganiger
BIOCAD INDIA PVT LTD
Outcome results
None listed