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

PHASE3CompletedINTERVENTIONAL
Enrollment

426

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

July 31, 2018

Study Completion Date

July 31, 2018

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

BCD-055

BCD-055 is infliximab biosimilar

BIOLOGICAL

Remicade®

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.

Trial Locations (39)

Unknown

"Institution of Healthcare 9th Municipal Clinical Hospital", Minsk

"Institution of Healthcare First Municipal Clinical Hospital", Minsk

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

"Institution of Healthcare Clinical Hospital of Vitebsk Region", Vitebsk

Shalby Hospital, Ahmedabad

Sapthagiri Institute of Medical Sciences and Research Centre, Bangalore

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

Apollo Gleneagles Hospital, Kolkata

Noble Hospital, Pune

Ruby Hall Clinic, Pune

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

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

"State Budgetary Institution of Healthcare Chelyabinsk Regional Clinical Hospital", Chelyabinsk

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

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

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

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

"Budgetary Medical Institution Kursk Regional Clinical Hospital", Kursk

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

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

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

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

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

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

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

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

"Federal State Budgetary Educational Institution of Higher Education Rostov State Medical University", Rostov-on-Don

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

Limited Liability Company Baltic Medicine, Saint Petersburg

Limited Liability Company BioEq, Saint Petersburg

North-Western State Medical University n.a. I.I.Mechnikov, Saint Petersburg

Private Medical Institution Evromedservis, Saint Petersburg

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

"State Budgetary Institution of Healthcare Leningrad Region Clinical Hospital", Saint Petersburg

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

"State Institution of Healthcare Regional Clinical Hospital", Saratov

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

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

"State Institution of Healthcare Municipal Clinical Emergency Hospital 25", Volgograd

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocad

INDUSTRY

NCT02762838 - Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter