Репозиторий Винницкого национального медицинского университета имени Н. И. Пирогова

A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study

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dc.contributor.author Yoo, Dae Hyun en
dc.contributor.author Hrycaj, P. en
dc.contributor.author Miranda, P. en
dc.contributor.author Ramiterre, E. en
dc.contributor.author Piotrowski, M. en
dc.contributor.author Shevchuk, S. en
dc.contributor.author Kovalenko, V. en
dc.contributor.author Prodanovic, N. en
dc.contributor.author Abello-Banfi, M. en
dc.contributor.author Gutierrez-Ureña, S. en
dc.contributor.author Morales-Olazabal, L. en
dc.contributor.author Tee, M. en
dc.contributor.author Jimenez, R. en
dc.contributor.author Zamani, O. en
dc.contributor.author Lee, Sang Joon en
dc.contributor.author Kim, Ho Ung en
dc.contributor.author Park, Won en
dc.contributor.author Müller-Ladner, U. en
dc.date.accessioned 2017-12-05T10:41:49Z
dc.date.available 2017-12-05T10:41:49Z
dc.date.issued 2013
dc.identifier.citation A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study / D. H. Yoo, P. Hrycaj, P. Miranda [et al.] // Annals of the Rheumatic Diseases. – 2013. – Vol. 72 (10). – P. 1613-1620. en
dc.identifier.uri https://dspace.vnmu.edu.ua/123456789/1589
dc.description.abstract To compare the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment. Phase III randomised, double-blind, multicentre, multinational, parallel-group study. Patients with active disease despite MTX (12.5-25 mg/week) were randomized to receive 3 mg/kg of CT-P13 (n=302) or INX (n=304) with MTX and folic acid. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 30. Therapeutic equivalence of clinical response according to ACR20 criteria was concluded if the 95% CI for the treatment difference was within ±15%. Secondary endpoints included ACR response criteria, European League Against Rheumatism (EULAR) response criteria, change in Disease Activity Score 28 (DAS28), Medical Outcomes Study Short-Form Health Survey (SF-36), Simplified Disease Activity Index, Clinical Disease Activity Index, as well as pharmacokinetic (PK) and pharmacodynamic (PD) parameters, safety and immunogenicity. At week 30, ACR20 responses were 60.9% for CT-P13 and 58.6% for INX (95% CI − 6% to 10%) in the intention-to-treat population. The proportions in CT-P13 and INX groups achieving good or moderate EULAR responses (C reactive protein (CRP)) at week 30 were 85.8% and 87.1%, respectively. Low disease activity or remission according to DAS28-CRP, ACR-EULAR remission rates, ACR50/ACR70 responses and all other PK and PD endpoints were highly similar at week 30. Incidence of drug-related adverse events (35.2% vs 35.9%) and detection of antidrug antibodies (48.4% vs 48.2%) were highly similar for CT-P13 and INX, respectively. CT-P13 demonstrated equivalent efficacy to INX at week 30, with a comparable PK profile and immunogenicity. CT-P13 was well tolerated, with a safety profile comparable with that of INX. en
dc.language.iso en en
dc.subject study randomised, double-blind, parallel-group en
dc.subject CT-P13
dc.subject infliximab (INX) en
dc.subject methotrexate (MTX) en
dc.subject rheumatoid arthritis active en
dc.subject PLANETRA study en
dc.subject efficacy en
dc.subject safety en
dc.subject parameters pharmacokinetic (PK) en
dc.subject parameters pharmacodynamic (PD) en
dc.title A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study en
dc.type Article en


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