Rheumatoid Arthritis
Conditions
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.
Interventions
Sponsors
Biocad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 | — |
| 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. |
Countries
Belarus, India, Russia
Outcome results
None listed