Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
NCT ID: NCT02762838
Last Updated: 2019-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
426 participants
INTERVENTIONAL
2016-01-31
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
BCD-055
BCD-055 is infliximab biosimilar
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.
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.
Remicade®
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.
Interventions
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BCD-055
BCD-055 is infliximab biosimilar
Remicade®
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Biocad
INDUSTRY
Responsible Party
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Principal Investigators
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Roman Ivanov, PhD
Role: STUDY_CHAIR
JSC BIOCAD
Locations
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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, , Belarus
Shalby Hospital
Ahmedabad, , India
Sapthagiri Institute of Medical Sciences and Research Centre
Bangalore, , India
S.P Medical College & A.G. of Hospitals
Bīkaner, , India
Apollo Gleneagles Hospital
Kolkata, , India
Noble Hospital
Pune, , India
Ruby Hall Clinic
Pune, , India
Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University"
Barnaul, , Russia
Federal State Autonomous Educational Institution of Higher Professional Education "Belgorod State National Research University"
Belgorod, , Russia
State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, , Russia
Regional State Autonomous Institution of Healthcare "Irkutsk Municipal Clinical Hospital No. 1"
Irkutsk, , Russia
State Autonomous Institution of Healthcare of Kemerovo Region "S. V. Belayev Kemerovo Regional Clinical Hospital"
Kemerovo, , Russia
Budgetary Institution of Khanty-Mansi Autonomous Region - Yugra "Regional Clinical Hospital"
Khanty-Mansiysk, , Russia
State Budgetary Institution of Healthcare "Research Institute - S. V. Ochapovskiy Regional Clinical Hospital 1
Krasnodar, , Russia
Budgetary Medical Institution "Kursk Regional Clinical Hospital"
Kursk, , Russia
Federal State Budgetary Scientific Institution "V. A. Nasonova Research Institute of Rheumatology"
Moscow, , Russia
State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
Moscow, , Russia
State Budgetary Institution of Moscow "O. M. Filatov Municipal Clinical Hospital 15" of the Moscow Healthcare Department
Moscow, , Russia
Private Institution of Healthcare "Railway Clinical Hospital at Nizhniy Novgorod Station of Russian Railways Open-Joint Stock Company"
Nizhny Novgorod, , Russia
State Budgetary Institution of Healthcare of Nizhniy Novgorod Region "N. A. Semashko Nizhniy Novgorod Regional Clinical Hospital"
Nizhny Novgorod, , Russia
State Autonomous Healthcare Institution of Novosibirsk Region, Municipal Clinic No 1
Novosibirsk, , Russia
Budgetary Institution of Healthcare of Omsk Region "Regional Clinical Hospital"
Omsk, , Russia
State Budgetary Institution of Healthcare of the Republic of Karelia "V. A. Baranov Republican Hospital"
Petrozavodsk, , Russia
Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"
Rostov-on-Don, , Russia
Federal State Budgetary Educational Institution of Higher Education "I. I. Mechnikov North-West State Medical University"
Saint Petersburg, , Russia
Limited Liability Company Baltic Medicine
Saint Petersburg, , Russia
Limited Liability Company BioEq
Saint Petersburg, , Russia
North-Western State Medical University n.a. I.I.Mechnikov
Saint Petersburg, , Russia
Private Medical Institution Evromedservis
Saint Petersburg, , Russia
Saint Petersburg State Budgetary Institution of Healthcare "Clinical Rheumatological Hospital 25"
Saint Petersburg, , Russia
State Budgetary Institution of Healthcare "Leningrad Region Clinical Hospital"
Saint Petersburg, , Russia
Non-state Healthcare Institution "Road Clinical Hospital at Saratov II Station of Russian Railways Open Joint-Stock Company"
Saratov, , Russia
State Institution of Healthcare "Regional Clinical Hospital"
Saratov, , Russia
Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University"
Tomsk, , Russia
State Budgetary Institution of Healthcare of Tyumen Region "Regional Clinical Hospital No. 1"
Tyumen, , Russia
State Institution of Healthcare "Municipal Clinical Emergency Hospital 25"
Volgograd, , Russia
Countries
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References
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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.
Other Identifiers
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BCD-055-3
Identifier Type: -
Identifier Source: org_study_id
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