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

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ClinicalTrials.gov Identifier: NCT02762838
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Biocad

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: BCD-055 Biological: Remicade® Drug: Methotrexate Drug: Folic acid Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BCD-055
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.
 Biological: BCD-055
BCD-055 is infliximab biosimilar
Other Name: infliximab

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

Drug: Folic acid
All patients will receive folic acid in a dose of 5 mg per week.
Active Comparator: Remicade®
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.
 Biological: Remicade®
Other Name: infliximab

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

Drug: Folic acid
All patients will receive folic acid in a dose of 5 mg per week.


Outcome Measures
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Primary Outcome Measures :
  1. Ratio of patients with ACR20 response after 14 weeks of therapy [ Time Frame: 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 Outcome Measures :
  1. Ratio of patients with ACR20 response after 30 and 54 weeks of therapy [ Time Frame: 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

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

  3. 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 Disease Activity Score 28 - C-reactive protein (DAS28-CRP(4), score 2.6-3.2) after 14, 30 and 54 weeks of therapy.

  4. 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 ]
    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.

  5. 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 ]
    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.

  6. 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 ]
    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.

  7. 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 ]
    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.

  8. 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 ]
    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.

  9. 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 ]
    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.

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

  11. CRP [ Time Frame: Screening, Week 14, Week 30, Week 54 ]
    Dynamics of blood level of C-reactive protein (CRP)

  12. ESR [ Time Frame: Screening, Week 14, Week 30, Week 54 ]
    Dynamics of Erythrocyte Sedimentation Rate

  13. Roentgenologic characteristics of abnormal joints after 54 weeks of therapy [ Time Frame: Week 54 ]
  14. Frequency of AE/SAE [ Time Frame: 54 weeks ]
  15. Frequency of AE 3-4 grade CTCAE [ Time Frame: 54 weeks ]
  16. Frequency of early withdrawals due to AE/SAE [ Time Frame: 54 weeks ]
  17. Percentage of patients who developed binding and neutralizing antibodies to infliximab [ Time Frame: Screening, Week 14, Week 30, Week 54 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762838


Locations
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Sponsors and Collaborators
Biocad
Investigators
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Study Chair: Roman Ivanov, PhD JSC BIOCAD
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT02762838    
Other Study ID Numbers: BCD-055-3
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Folic Acid
Methotrexate
Infliximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Gastrointestinal Agents
Hematinics
Vitamin B Complex
Vitamins