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

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biocad
• Treatments: Folic Acid; Infliximab; Methotrexate; Vitamin B Complex

Criteria

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.