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

NCT02762838 | Completed Phase 3

• 1 other identifier: BCD-055-3
• Study Type: interventional
• Target: 426
• Locations: 3 countries
• Sites: 39

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

  Week 14

Secondary Outcomes (17)

• Ratio of patients with ACR20 response after 30 and 54 weeks of therapy

  Week 30, Week 54

• Ratio of patients with ACR50 and 70 response 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 DAS28-CRP(4) 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

  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

  Week 14, Week 30, Week 54

Study Arms (2)

BCD-055

EXPERIMENTAL

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; Drug: Methotrexate; Drug: Folic acid

Remicade®

ACTIVE COMPARATOR

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®; Drug: Methotrexate; Drug: Folic acid

Interventions

BCD-055 BIOLOGICAL

BCD-055 is infliximab biosimilar

Also known as: infliximab

BCD-055

Remicade® BIOLOGICAL

Also known as: infliximab

Remicade®

Methotrexate DRUG

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

BCD-055; Remicade®

Folic acid DRUG

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

BCD-055; Remicade®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocad: lead

Study Sites (39)

Institution of Healthcare "9th Municipal Clinical Hospital"

Minsk, Belarus

Location

Institution of Healthcare "First Municipal Clinical Hospital"

Minsk, Belarus

Location

Institution of Healthcare "Ordena Trudovogo Krasnogo Znameni Regional Clinical Hospital"

Minsk, Belarus

Location

Institution of Healthcare "Clinical Hospital of Vitebsk Region"

Vitebsk, Belarus

Location

Shalby Hospital

Ahmedabad, India

Location

Sapthagiri Institute of Medical Sciences and Research Centre

Bangalore, India

Location

S.P Medical College & A.G. of Hospitals

Bīkaner, India

Location

Apollo Gleneagles Hospital

Kolkata, India

Location

Noble Hospital

Pune, India

Location

Ruby Hall Clinic

Pune, India

Location

Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University"

Barnaul, Russia

Location

Federal State Autonomous Educational Institution of Higher Professional Education "Belgorod State National Research University"

Belgorod, Russia

Location

State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Hospital"

Chelyabinsk, Russia

Location

Regional State Autonomous Institution of Healthcare "Irkutsk Municipal Clinical Hospital No. 1"

Irkutsk, Russia

Location

State Autonomous Institution of Healthcare of Kemerovo Region "S. V. Belayev Kemerovo Regional Clinical Hospital"

Kemerovo, Russia

Location

Budgetary Institution of Khanty-Mansi Autonomous Region - Yugra "Regional Clinical Hospital"

Khanty-Mansiysk, Russia

Location

State Budgetary Institution of Healthcare "Research Institute - S. V. Ochapovskiy Regional Clinical Hospital 1

Krasnodar, Russia

Location

Budgetary Medical Institution "Kursk Regional Clinical Hospital"

Kursk, Russia

Location

Federal State Budgetary Scientific Institution "V. A. Nasonova Research Institute of Rheumatology"

Moscow, Russia

Location

State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University

Moscow, Russia

Location

State Budgetary Institution of Moscow "O. M. Filatov Municipal Clinical Hospital 15" of the Moscow Healthcare Department

Moscow, Russia

Location

Private Institution of Healthcare "Railway Clinical Hospital at Nizhniy Novgorod Station of Russian Railways Open-Joint Stock Company"

Nizhny Novgorod, Russia

Location

State Budgetary Institution of Healthcare of Nizhniy Novgorod Region "N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital"

Nizhny Novgorod, Russia

Location

State Autonomous Healthcare Institution of Novosibirsk Region, Municipal Clinic No 1

Novosibirsk, Russia

Location

Budgetary Institution of Healthcare of Omsk Region "Regional Clinical Hospital"

Omsk, Russia

Location

State Budgetary Institution of Healthcare of the Republic of Karelia "V. A. Baranov Republican Hospital"

Petrozavodsk, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"

Rostov-on-Don, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "I. I. Mechnikov North-West State Medical University"

Saint Petersburg, Russia

Location

Limited Liability Company Baltic Medicine

Saint Petersburg, Russia

Location

Limited Liability Company BioEq

Saint Petersburg, Russia

Location

North-Western State Medical University n.a. I.I.Mechnikov

Saint Petersburg, Russia

Location

Private Medical Institution Evromedservis

Saint Petersburg, Russia

Location

Saint Petersburg State Budgetary Institution of Healthcare "Clinical Rheumatological Hospital 25"

Saint Petersburg, Russia

Location

State Budgetary Institution of Healthcare "Leningrad Region Clinical Hospital"

Saint Petersburg, Russia

Location

Non-state Healthcare Institution "Road Clinical Hospital at Saratov II Station of Russian Railways Open Joint-Stock Company"

Saratov, Russia

Location

State Institution of Healthcare "Regional Clinical Hospital"

Saratov, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University"

Tomsk, Russia

Location

State Budgetary Institution of Healthcare of Tyumen Region "Regional Clinical Hospital No. 1"

Tyumen, Russia

Location

State Institution of Healthcare "Municipal Clinical Emergency Hospital 25"

Volgograd, Russia

Location

Related Publications (1)

• 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.

  PMID: 31292709 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

BCD-055; Infliximab; Methotrexate; Folic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Roman Ivanov, PhD

  JSC BIOCAD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: May 5, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 14, 2019

Record last verified: 2019-06

Locations

RU (29); BE (4); IN (6)