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

Biocad

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: Folic acid; Biological: BCD-055; Biological: Remicade®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02762838

BCD-055-3

Details and patient eligibility

About

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.

Enrollment: 426 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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426 participants in 2 patient groups

BCD-055

Experimental group

Description:

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.

Treatment:

Biological: BCD-055

Drug: Folic acid

Drug: Methotrexate

Remicade®

Active Comparator group

Description:

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.

Treatment:

Biological: Remicade®

Drug: Folic acid

Drug: Methotrexate