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

Phase 3 Completed 426 enrolled Biocad

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2016-01
Primary completion: 2018-07
Completion: 2018-07

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BCD-055	Unknown	3 mg/kg	—
Comparator	Infliximab	Monoclonal antibody	3 mg/kg	—
Background	Methotrexate	Small molecule	10 mg	—
Background	Methotrexate	Small molecule	25 mg	—
Background	folic acid	Other / unclassified	5 mg	—

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

Summary

Timeline

Publications

Drugs

Indications