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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02762838
• Date of registration: 04/04/2016
• Prospective Registration: No
• Primary sponsor: Biocad
• Public title: Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
• Scientific title: 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
• Date of first enrolment: January 2016
• Target sample size: 426
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02762838
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Belarus, India, Russian Federation

Contacts

• Name: Roman Ivanov, PhD
• Affiliation: JSC BIOCAD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Methotrexate

Biological: Remicade®

Biological: BCD-055

Drug: Folic acid

Primary Outcome(s)

Ratio of patients with ACR20 response after 14 weeks of therapy [Time Frame: Week 14]

Secondary Outcome(s)

Ratio of patients with low activity of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy [Time Frame: Week 14, Week 30, Week 54]

Frequency of early withdrawals due to AE/SAE [Time Frame: 54 weeks]

CRP [Time Frame: Screening, Week 14, Week 30, Week 54]

Ratio of patients with remission of rheumatoid arthritis according to index DAS28 after 14, 30 and 54 weeks of therapy [Time Frame: Week 14, Week 30, Week 54]

Percentage of patients who developed binding and neutralizing antibodies to infliximab [Time Frame: Screening, 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 [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 [Time Frame: Week 14, Week 30, Week 54]

ESR [Time Frame: Screening, Week 14, Week 30, Week 54]

Ratio of patients with ACR20 response after 30 and 54 weeks of therapy [Time Frame: Week 30, Week 54]

Ratio of patients with remission of rheumatoid arthritis according to ACR-EULAR criteria after 14, 30 and 54 weeks of therapy [Time Frame: Week 14, Week 30, Week 54]

Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy [Time Frame: Screening, Week 14, Week 30, Week 54]

Ratio of patients with ACR50 and 70 response after 14, 30 and 54 weeks of therapy [Time Frame: Week 14, Week 30, Week 54]

Roentgenologic characteristics of abnormal joints after 54 weeks of therapy [Time Frame: Week 54]

Frequency of AE/SAE [Time Frame: 54 weeks]

Ratio of patients with remission of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy [Time Frame: Week 14, Week 30, Week 54]

Frequency of AE 3-4 grade CTCAE [Time Frame: 54 weeks]

Ratio of patients with remission of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy [Time Frame: Week 14, Week 30, Week 54]

Secondary ID(s)

BCD-055-3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors