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

June 12, 2019 updated by: Biocad

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

426

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus
        • Institution of Healthcare "9th Municipal Clinical Hospital"
      • Minsk, Belarus
        • Institution of Healthcare "First Municipal Clinical Hospital"
      • Minsk, Belarus
        • Institution of Healthcare "Ordena Trudovogo Krasnogo Znameni Regional Clinical Hospital"
      • Vitebsk, Belarus
        • Institution of Healthcare "Clinical Hospital of Vitebsk Region"
  • India
      • Ahmedabad, India
        • Shalby Hospital
      • Bangalore, India
        • Sapthagiri Institute of Medical Sciences and Research Centre
      • Bīkaner, India
        • S.P Medical College & A.G. of Hospitals
      • Kolkata, India
        • Apollo Gleneagles Hospital
      • Pune, India
        • Ruby Hall Clinic
      • Pune, India
        • Noble Hospital
  • Russian Federation
      • Barnaul, Russian Federation
        • Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University"
      • Belgorod, Russian Federation
        • Federal State Autonomous Educational Institution of Higher Professional Education "Belgorod State National Research University"
      • Chelyabinsk, Russian Federation
        • State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Hospital"
      • Irkutsk, Russian Federation
        • Regional State Autonomous Institution of Healthcare "Irkutsk Municipal Clinical Hospital No. 1"
      • Kemerovo, Russian Federation
        • State Autonomous Institution of Healthcare of Kemerovo Region "S. V. Belayev Kemerovo Regional Clinical Hospital"
      • Khanty-Mansiysk, Russian Federation
        • Budgetary Institution of Khanty-Mansi Autonomous Region - Yugra "Regional Clinical Hospital"
      • Krasnodar, Russian Federation
        • State Budgetary Institution of Healthcare "Research Institute - S. V. Ochapovskiy Regional Clinical Hospital 1
      • Kursk, Russian Federation
        • Budgetary Medical Institution "Kursk Regional Clinical Hospital"
      • Moscow, Russian Federation
        • State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
      • Moscow, Russian Federation
        • Federal State Budgetary Scientific Institution "V. A. Nasonova Research Institute of Rheumatology"
      • Moscow, Russian Federation
        • State Budgetary Institution of Moscow "O. M. Filatov Municipal Clinical Hospital 15" of the Moscow Healthcare Department
      • Nizhny Novgorod, Russian Federation
        • Private Institution of Healthcare "Railway Clinical Hospital at Nizhniy Novgorod Station of Russian Railways Open-Joint Stock Company"
      • Nizhny Novgorod, Russian Federation
        • State Budgetary Institution of Healthcare of Nizhniy Novgorod Region "N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital"
      • Novosibirsk, Russian Federation
        • State Autonomous Healthcare Institution of Novosibirsk Region, Municipal Clinic No 1
      • Omsk, Russian Federation
        • Budgetary Institution of Healthcare of Omsk Region "Regional Clinical Hospital"
      • Petrozavodsk, Russian Federation
        • State Budgetary Institution of Healthcare of the Republic of Karelia "V. A. Baranov Republican Hospital"
      • Rostov-on-Don, Russian Federation
        • Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"
      • Saint Petersburg, Russian Federation
        • Federal State Budgetary Educational Institution of Higher Education "I. I. Mechnikov North-West State Medical University"
      • Saint Petersburg, Russian Federation
        • Limited Liability Company Baltic Medicine
      • Saint Petersburg, Russian Federation
        • Limited Liability Company BioEq
      • Saint Petersburg, Russian Federation
        • Private Medical Institution Evromedservis
      • Saint Petersburg, Russian Federation
        • Saint Petersburg State Budgetary Institution of Healthcare "Clinical Rheumatological Hospital 25"
      • Saint Petersburg, Russian Federation
        • State Budgetary Institution of Healthcare "Leningrad Region Clinical Hospital"
      • Saratov, Russian Federation
        • Non-state Healthcare Institution "Road Clinical Hospital at Saratov II Station of Russian Railways Open Joint-Stock Company"
      • Saratov, Russian Federation
        • State Institution of Healthcare "Regional Clinical Hospital"
      • St.Petersburg, Russian Federation
        • North-Western State Medical University n.a. I.I.Mechnikov
      • Tomsk, Russian Federation
        • Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University"
      • Tyumen, Russian Federation
        • State Budgetary Institution of Healthcare of Tyumen Region "Regional Clinical Hospital No. 1"
      • Volgograd, Russian Federation
        • State Institution of Healthcare "Municipal Clinical Emergency Hospital 25"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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.
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.
Biological: Remicade®
Other Names:
  • infliximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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 Disease Activity Score 28 - C-reactive protein (DAS28-CRP(4), score 2.6-3.2) after 14, 30 and 54 weeks of therapy.
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
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.
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
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.
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
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.
Week 14, Week 30, Week 54
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.
Week 14, Week 30, Week 54
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.
Week 14, 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
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.
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
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.
Screening, Week 14, Week 30, Week 54
CRP
Time Frame: Screening, Week 14, Week 30, Week 54
Dynamics of blood level of C-reactive protein (CRP)
Screening, Week 14, Week 30, Week 54
ESR
Time Frame: Screening, Week 14, Week 30, Week 54
Dynamics of Erythrocyte Sedimentation Rate
Screening, Week 14, Week 30, Week 54
Roentgenologic characteristics of abnormal joints after 54 weeks of therapy
Time Frame: Week 54
Week 54
Frequency of AE/SAE
Time Frame: 54 weeks
54 weeks
Frequency of AE 3-4 grade CTCAE
Time Frame: 54 weeks
54 weeks
Frequency of early withdrawals due to AE/SAE
Time Frame: 54 weeks
54 weeks
Percentage of patients who developed binding and neutralizing antibodies to infliximab
Time Frame: Screening, Week 14, Week 30, Week 54
Screening, Week 14, Week 30, Week 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

July 1, 2018

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (ESTIMATE)

May 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2019

Last Update Submitted That Met QC Criteria

June 12, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCD-055-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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