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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762838
• Other study ID #: BCD-055-3
• Status: Completed
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: July 2018

Study information

• Verified date: June 2019
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• BCD-055
BCD-055 is infliximab biosimilar
• Remicade®

Drug:
• Methotrexate
All patients will receive methotrexate in a dose from 10 to 25 mg per week.
• Folic acid
All patients will receive folic acid in a dose of 5 mg per week.

Locations

Country	Name	City	State
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"	Minsk
Belarus	Institution of Healthcare "Clinical Hospital of Vitebsk Region"	Vitebsk
India	Shalby Hospital	Ahmedabad
India	Sapthagiri Institute of Medical Sciences and Research Centre	Bangalore
India	S.P Medical College & A.G. of Hospitals	Bikaner
India	Apollo Gleneagles Hospital	Kolkata
India	Noble Hospital	Pune
India	Ruby Hall Clinic	Pune
Russian Federation	Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University"	Barnaul
Russian Federation	Federal State Autonomous Educational Institution of Higher Professional Education "Belgorod State National Research University"	Belgorod
Russian Federation	State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Hospital"	Chelyabinsk
Russian Federation	Regional State Autonomous Institution of Healthcare "Irkutsk Municipal Clinical Hospital No. 1"	Irkutsk
Russian Federation	State Autonomous Institution of Healthcare of Kemerovo Region "S. V. Belayev Kemerovo Regional Clinical Hospital"	Kemerovo
Russian Federation	Budgetary Institution of Khanty-Mansi Autonomous Region - Yugra "Regional Clinical Hospital"	Khanty-Mansiysk
Russian Federation	State Budgetary Institution of Healthcare "Research Institute - S. V. Ochapovskiy Regional Clinical Hospital 1	Krasnodar
Russian Federation	Budgetary Medical Institution "Kursk Regional Clinical Hospital"	Kursk
Russian Federation	Federal State Budgetary Scientific Institution "V. A. Nasonova Research Institute of Rheumatology"	Moscow
Russian Federation	State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University	Moscow
Russian Federation	State Budgetary Institution of Moscow "O. M. Filatov Municipal Clinical Hospital 15" of the Moscow Healthcare Department	Moscow
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"	Nizhny Novgorod
Russian Federation	State Autonomous Healthcare Institution of Novosibirsk Region, Municipal Clinic No 1	Novosibirsk
Russian Federation	Budgetary Institution of Healthcare of Omsk Region "Regional Clinical Hospital"	Omsk
Russian Federation	State Budgetary Institution of Healthcare of the Republic of Karelia "V. A. Baranov Republican Hospital"	Petrozavodsk
Russian Federation	Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"	Rostov-on-Don
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"	Saint Petersburg
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"	Saratov
Russian Federation	North-Western State Medical University n.a. I.I.Mechnikov	St.Petersburg
Russian Federation	Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University"	Tomsk
Russian Federation	State Budgetary Institution of Healthcare of Tyumen Region "Regional Clinical Hospital No. 1"	Tyumen
Russian Federation	State Institution of Healthcare "Municipal Clinical Emergency Hospital 25"	Volgograd

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Countries where clinical trial is conducted

Belarus,  India,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Week 30, Week 54
Secondary	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	Week 14, Week 30, Week 54
Secondary	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.	Week 14, Week 30, Week 54
Secondary	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.	Week 14, Week 30, Week 54
Secondary	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.	Week 14, Week 30, Week 54
Secondary	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.	Week 14, Week 30, Week 54
Secondary	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.	Week 14, Week 30, Week 54
Secondary	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.	Week 14, Week 30, Week 54
Secondary	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.	Week 14, Week 30, Week 54
Secondary	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.	Screening, Week 14, Week 30, Week 54
Secondary	CRP	Dynamics of blood level of C-reactive protein (CRP)	Screening, Week 14, Week 30, Week 54
Secondary	ESR	Dynamics of Erythrocyte Sedimentation Rate	Screening, Week 14, Week 30, Week 54
Secondary	Roentgenologic characteristics of abnormal joints after 54 weeks of therapy		Week 54
Secondary	Frequency of AE/SAE		54 weeks
Secondary	Frequency of AE 3-4 grade CTCAE		54 weeks
Secondary	Frequency of early withdrawals due to AE/SAE		54 weeks
Secondary	Percentage of patients who developed binding and neutralizing antibodies to infliximab		Screening, Week 14, Week 30, Week 54