Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Biocad426 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

426

Conditions

Rheumatoid Arthritis

Interventions

BCD-055BIOLOGICAL

BCD-055 is infliximab biosimilar

Remicade®BIOLOGICAL

MethotrexateDRUG

All patients will receive methotrexate in a dose from 10 to 25 mg per week.

Folic acid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (39)

Outcomes

Primary Outcomes

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

Time frame: Week 14

Secondary Outcomes

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

Time frame: Week 30, Week 54

Ratio of patients with ACR50 and 70 response after 14, 30 and 54 weeks of therapy

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

Time frame: 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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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...and 29 more locations