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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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BCD-055
Remicade®
Methotrexate
Folic acid
Sponsored by
Biocad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BCD-055

Remicade®

Arm 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.

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.

Outcomes

Primary Outcome Measures

Ratio of patients with ACR20 response after 14 weeks of therapy
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

Ratio of patients with ACR20 response after 30 and 54 weeks of therapy
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
Ratio of patients with ACR50 and 70 response after 14, 30 and 54 weeks of therapy
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
Ratio of patients with low activity of rheumatoid arthritis according to index DAS28-CRP(4) after 14, 30 and 54 weeks of therapy
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.
Ratio of patients with low activity of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy
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.
Ratio of patients with low activity of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy
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.
Ratio of patients with remission of rheumatoid arthritis according to index DAS28 after 14, 30 and 54 weeks of therapy
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.
Ratio of patients with remission of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy
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.
Ratio of patients with remission of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy
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.
Ratio of patients with remission of rheumatoid arthritis according to ACR-EULAR criteria after 14, 30 and 54 weeks of therapy
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.
Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy
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.
CRP
Dynamics of blood level of C-reactive protein (CRP)
ESR
Dynamics of Erythrocyte Sedimentation Rate
Roentgenologic characteristics of abnormal joints after 54 weeks of therapy
Frequency of AE/SAE
Frequency of AE 3-4 grade CTCAE
Frequency of early withdrawals due to AE/SAE
Percentage of patients who developed binding and neutralizing antibodies to infliximab

Full Information

First Posted
April 4, 2016
Last Updated
June 12, 2019
Sponsor
Biocad
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1. Study Identification

Unique Protocol Identification Number
NCT02762838
Brief Title
Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocad

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
426 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCD-055
Arm Type
Experimental
Arm 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.
Arm Title
Remicade®
Arm Type
Active Comparator
Arm 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.
Intervention Type
Biological
Intervention Name(s)
BCD-055
Other Intervention Name(s)
infliximab
Intervention Description
BCD-055 is infliximab biosimilar
Intervention Type
Biological
Intervention Name(s)
Remicade®
Other Intervention Name(s)
infliximab
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
All patients will receive methotrexate in a dose from 10 to 25 mg per week.
Intervention Type
Drug
Intervention Name(s)
Folic acid
Intervention Description
All patients will receive folic acid in a dose of 5 mg per week.
Primary Outcome Measure Information:
Title
Ratio of patients with ACR20 response after 14 weeks of therapy
Description
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
Time Frame
Week 14
Secondary Outcome Measure Information:
Title
Ratio of patients with ACR20 response after 30 and 54 weeks of therapy
Description
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
Time Frame
Week 30, Week 54
Title
Ratio of patients with ACR50 and 70 response after 14, 30 and 54 weeks of therapy
Description
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
Time Frame
Week 14, Week 30, Week 54
Title
Ratio of patients with low activity of rheumatoid arthritis according to index DAS28-CRP(4) after 14, 30 and 54 weeks of therapy
Description
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.
Time Frame
Week 14, Week 30, Week 54
Title
Ratio of patients with low activity of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy
Description
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.
Time Frame
Week 14, Week 30, Week 54
Title
Ratio of patients with low activity of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy
Description
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.
Time Frame
Week 14, Week 30, Week 54
Title
Ratio of patients with remission of rheumatoid arthritis according to index DAS28 after 14, 30 and 54 weeks of therapy
Description
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.
Time Frame
Week 14, Week 30, Week 54
Title
Ratio of patients with remission of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy
Description
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.
Time Frame
Week 14, Week 30, Week 54
Title
Ratio of patients with remission of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy
Description
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.
Time Frame
Week 14, Week 30, Week 54
Title
Ratio of patients with remission of rheumatoid arthritis according to ACR-EULAR criteria after 14, 30 and 54 weeks of therapy
Description
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.
Time Frame
Week 14, Week 30, Week 54
Title
Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy
Description
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.
Time Frame
Screening, Week 14, Week 30, Week 54
Title
CRP
Description
Dynamics of blood level of C-reactive protein (CRP)
Time Frame
Screening, Week 14, Week 30, Week 54
Title
ESR
Description
Dynamics of Erythrocyte Sedimentation Rate
Time Frame
Screening, Week 14, Week 30, Week 54
Title
Roentgenologic characteristics of abnormal joints after 54 weeks of therapy
Time Frame
Week 54
Title
Frequency of AE/SAE
Time Frame
54 weeks
Title
Frequency of AE 3-4 grade CTCAE
Time Frame
54 weeks
Title
Frequency of early withdrawals due to AE/SAE
Time Frame
54 weeks
Title
Percentage of patients who developed binding and neutralizing antibodies to infliximab
Time Frame
Screening, Week 14, Week 30, Week 54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Ivanov, PhD
Organizational Affiliation
JSC BIOCAD
Official's Role
Study Chair
Facility Information:
Facility Name
Institution of Healthcare "9th Municipal Clinical Hospital"
City
Minsk
Country
Belarus
Facility Name
Institution of Healthcare "First Municipal Clinical Hospital"
City
Minsk
Country
Belarus
Facility Name
Institution of Healthcare "Ordena Trudovogo Krasnogo Znameni Regional Clinical Hospital"
City
Minsk
Country
Belarus
Facility Name
Institution of Healthcare "Clinical Hospital of Vitebsk Region"
City
Vitebsk
Country
Belarus
Facility Name
Shalby Hospital
City
Ahmedabad
Country
India
Facility Name
Sapthagiri Institute of Medical Sciences and Research Centre
City
Bangalore
Country
India
Facility Name
S.P Medical College & A.G. of Hospitals
City
Bīkaner
Country
India
Facility Name
Apollo Gleneagles Hospital
City
Kolkata
Country
India
Facility Name
Noble Hospital
City
Pune
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
Country
India
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University"
City
Barnaul
Country
Russian Federation
Facility Name
Federal State Autonomous Educational Institution of Higher Professional Education "Belgorod State National Research University"
City
Belgorod
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Hospital"
City
Chelyabinsk
Country
Russian Federation
Facility Name
Regional State Autonomous Institution of Healthcare "Irkutsk Municipal Clinical Hospital No. 1"
City
Irkutsk
Country
Russian Federation
Facility Name
State Autonomous Institution of Healthcare of Kemerovo Region "S. V. Belayev Kemerovo Regional Clinical Hospital"
City
Kemerovo
Country
Russian Federation
Facility Name
Budgetary Institution of Khanty-Mansi Autonomous Region - Yugra "Regional Clinical Hospital"
City
Khanty-Mansiysk
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare "Research Institute - S. V. Ochapovskiy Regional Clinical Hospital 1
City
Krasnodar
Country
Russian Federation
Facility Name
Budgetary Medical Institution "Kursk Regional Clinical Hospital"
City
Kursk
Country
Russian Federation
Facility Name
Federal State Budgetary Scientific Institution "V. A. Nasonova Research Institute of Rheumatology"
City
Moscow
Country
Russian Federation
Facility Name
State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
City
Moscow
Country
Russian Federation
Facility Name
State Budgetary Institution of Moscow "O. M. Filatov Municipal Clinical Hospital 15" of the Moscow Healthcare Department
City
Moscow
Country
Russian Federation
Facility Name
Private Institution of Healthcare "Railway Clinical Hospital at Nizhniy Novgorod Station of Russian Railways Open-Joint Stock Company"
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare of Nizhniy Novgorod Region "N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital"
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution of Novosibirsk Region, Municipal Clinic No 1
City
Novosibirsk
Country
Russian Federation
Facility Name
Budgetary Institution of Healthcare of Omsk Region "Regional Clinical Hospital"
City
Omsk
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare of the Republic of Karelia "V. A. Baranov Republican Hospital"
City
Petrozavodsk
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "I. I. Mechnikov North-West State Medical University"
City
Saint Petersburg
Country
Russian Federation
Facility Name
Limited Liability Company Baltic Medicine
City
Saint Petersburg
Country
Russian Federation
Facility Name
Limited Liability Company BioEq
City
Saint Petersburg
Country
Russian Federation
Facility Name
Private Medical Institution Evromedservis
City
Saint Petersburg
Country
Russian Federation
Facility Name
Saint Petersburg State Budgetary Institution of Healthcare "Clinical Rheumatological Hospital 25"
City
Saint Petersburg
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare "Leningrad Region Clinical Hospital"
City
Saint Petersburg
Country
Russian Federation
Facility Name
Non-state Healthcare Institution "Road Clinical Hospital at Saratov II Station of Russian Railways Open Joint-Stock Company"
City
Saratov
Country
Russian Federation
Facility Name
State Institution of Healthcare "Regional Clinical Hospital"
City
Saratov
Country
Russian Federation
Facility Name
North-Western State Medical University n.a. I.I.Mechnikov
City
St.Petersburg
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University"
City
Tomsk
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare of Tyumen Region "Regional Clinical Hospital No. 1"
City
Tyumen
Country
Russian Federation
Facility Name
State Institution of Healthcare "Municipal Clinical Emergency Hospital 25"
City
Volgograd
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31292709
Citation
Lila AM, Mazurov VI, Denisov LN, Nesmeyanova OB, Ilivanova EP, Eremeeva AV, Usacheva JV, Dokukina EA, Chernyaeva EV, Ivanov RA. A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study. Rheumatol Int. 2019 Sep;39(9):1537-1546. doi: 10.1007/s00296-019-04359-9. Epub 2019 Jul 10.
Results Reference
derived

Learn more about this trial

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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