FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2883406108> ?p ?o ?g. }

• W2883406108 endingPage "943" @default.
• W2883406108 startingPage "934" @default.
• W2883406108 abstract "This multinational, randomized, double-blind trial, (ClinicalTrials.gov identifier NCT02149121) was designed to demonstrate equivalence in pharmacokinetics and efficacy between CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA). Adults with active RA were treated with CT-P10, United States-sourced RTX (US-RTX; Rituxan®), or European Union-sourced RTX (EU-RTX; MabThera®) at weeks 0 and 2. The co-primary pharmacokinetic endpoints were area under the serum concentration–time curve (AUC) from time zero to last measurable concentration (AUC0–last), AUC from time zero to infinity (AUC0–∞), and maximum concentration (Cmax) after two infusions. The primary efficacy endpoint was change from baseline to week 24 in Disease Activity Score using 28 joints-C-reactive protein (DAS28-CRP). Pharmacodynamics, immunogenicity, and safety were also assessed. 372 patients were randomly assigned to CT-P10 (n = 161) or RTX (n = 211 [US-RTX, n = 151; EU-RTX, n = 60]). For the co-primary pharmacokinetic endpoints, 90% confidence intervals (CI) for ratios of geometric means (CT-P10/US-RTX, CT-P10/EU-RTX or EU-RTX/US-RTX) all fell within the equivalence margin of 80–125%. Adjusted least squares (LS) mean (standard error) change from baseline in DAS28-CRP at week 24 was −2.13 (0.175) for CT-P10 and −2.09 (0.176) for RTX. The 95% CI (−0.29, 0.21) of the estimated treatment difference between CT-P10 and RTX (−0.04) was entirely within the efficacy equivalence margin of ±0.5. Pharmacodynamics, immunogenicity, and safety profiles were similar for CT-P10 and RTX. The pharmacokinetics of CT-P10, US-RTX, and EU-RTX were equivalent. CT-P10 and RTX were also equivalent in terms of efficacy and displayed similar pharmacodynamic, immunogenicity, and safety profiles up to week 24." @default.
• W2883406108 created "2018-08-03" @default.
• W2883406108 creator A5002226800 @default.
• W2883406108 creator A5003040843 @default.
• W2883406108 creator A5003254047 @default.
• W2883406108 creator A5004670805 @default.
• W2883406108 creator A5005653295 @default.
• W2883406108 creator A5006303399 @default.
• W2883406108 creator A5007364793 @default.
• W2883406108 creator A5010317229 @default.
• W2883406108 creator A5017006258 @default.
• W2883406108 creator A5024934467 @default.
• W2883406108 creator A5028916428 @default.
• W2883406108 creator A5032940273 @default.
• W2883406108 creator A5036530922 @default.
• W2883406108 creator A5043732079 @default.
• W2883406108 creator A5048311947 @default.
• W2883406108 creator A5052206707 @default.
• W2883406108 creator A5057669105 @default.
• W2883406108 creator A5059844029 @default.
• W2883406108 creator A5064707258 @default.
• W2883406108 creator A5066408904 @default.
• W2883406108 creator A5072419462 @default.
• W2883406108 creator A5076575654 @default.
• W2883406108 creator A5076995360 @default.
• W2883406108 creator A5078360050 @default.
• W2883406108 creator A5084395370 @default.
• W2883406108 creator A5089561583 @default.
• W2883406108 creator A5090693306 @default.
• W2883406108 date "2018-07-16" @default.
• W2883406108 modified "2023-10-14" @default.
• W2883406108 title "Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial" @default.
• W2883406108 cites W1974096487 @default.
• W2883406108 cites W2001917088 @default.
• W2883406108 cites W2013797706 @default.
• W2883406108 cites W2024644107 @default.
• W2883406108 cites W2077158310 @default.
• W2883406108 cites W2118994799 @default.
• W2883406108 cites W2129671292 @default.
• W2883406108 cites W2142004396 @default.
• W2883406108 cites W2151444904 @default.
• W2883406108 cites W2152348310 @default.
• W2883406108 cites W2163100333 @default.
• W2883406108 cites W2165459235 @default.
• W2883406108 cites W2185272193 @default.
• W2883406108 cites W2519049669 @default.
• W2883406108 cites W2546839065 @default.
• W2883406108 cites W2606245581 @default.
• W2883406108 cites W2623304866 @default.
• W2883406108 cites W2625118180 @default.
• W2883406108 cites W2736281699 @default.
• W2883406108 cites W2971217817 @default.
• W2883406108 doi "https://doi.org/10.1080/19420862.2018.1487912" @default.
• W2883406108 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/6152436" @default.
• W2883406108 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/30010481" @default.
• W2883406108 hasPublicationYear "2018" @default.
• W2883406108 type Work @default.
• W2883406108 sameAs 2883406108 @default.
• W2883406108 citedByCount "41" @default.
• W2883406108 countsByYear W28834061082019 @default.
• W2883406108 countsByYear W28834061082020 @default.
• W2883406108 countsByYear W28834061082021 @default.
• W2883406108 countsByYear W28834061082022 @default.
• W2883406108 countsByYear W28834061082023 @default.
• W2883406108 crossrefType "journal-article" @default.
• W2883406108 hasAuthorship W2883406108A5002226800 @default.
• W2883406108 hasAuthorship W2883406108A5003040843 @default.
• W2883406108 hasAuthorship W2883406108A5003254047 @default.
• W2883406108 hasAuthorship W2883406108A5004670805 @default.
• W2883406108 hasAuthorship W2883406108A5005653295 @default.
• W2883406108 hasAuthorship W2883406108A5006303399 @default.
• W2883406108 hasAuthorship W2883406108A5007364793 @default.
• W2883406108 hasAuthorship W2883406108A5010317229 @default.
• W2883406108 hasAuthorship W2883406108A5017006258 @default.
• W2883406108 hasAuthorship W2883406108A5024934467 @default.
• W2883406108 hasAuthorship W2883406108A5028916428 @default.
• W2883406108 hasAuthorship W2883406108A5032940273 @default.
• W2883406108 hasAuthorship W2883406108A5036530922 @default.
• W2883406108 hasAuthorship W2883406108A5043732079 @default.
• W2883406108 hasAuthorship W2883406108A5048311947 @default.
• W2883406108 hasAuthorship W2883406108A5052206707 @default.
• W2883406108 hasAuthorship W2883406108A5057669105 @default.
• W2883406108 hasAuthorship W2883406108A5059844029 @default.
• W2883406108 hasAuthorship W2883406108A5064707258 @default.
• W2883406108 hasAuthorship W2883406108A5066408904 @default.
• W2883406108 hasAuthorship W2883406108A5072419462 @default.
• W2883406108 hasAuthorship W2883406108A5076575654 @default.
• W2883406108 hasAuthorship W2883406108A5076995360 @default.
• W2883406108 hasAuthorship W2883406108A5078360050 @default.
• W2883406108 hasAuthorship W2883406108A5084395370 @default.
• W2883406108 hasAuthorship W2883406108A5089561583 @default.
• W2883406108 hasAuthorship W2883406108A5090693306 @default.
• W2883406108 hasBestOaLocation W28834061081 @default.
• W2883406108 hasConcept C105639569 @default.
• W2883406108 hasConcept C111113717 @default.
• W2883406108 hasConcept C112705442 @default.
• W2883406108 hasConcept C126322002 @default.
• W2883406108 hasConcept C126894567 @default.

• next