✓ Translated by DotMD AI Clinical Council Source: Annals of hematology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #34398258 ↗

Phase III Randomized Trial: Randomized multicenter noninferiority phase III clinical trial of the first biosimilar of eculizumab (N = 16)

Original Paper Title: “Randomized multicenter noninferiority phase III clinical trial of the first biosimilar of eculizumab”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
N = 16
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • The data obtained confirm that the Biosimilar is not inferior to the Originator in terms of the main efficacy parameter, and is also comparable with it in terms of safety and additional efficacy parameters. Clinicaltrials.gov identifier: NCT04463056.
  • Study Design & Sample: Phase III Randomized Trial published in Annals of hematology (N = 16 human participants).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Annals of hematology (2021), this phase iii randomized trial evaluating 16 human participants investigated: Currently, eculizumab is the main effective treatment for paroxysmal nocturnal hemoglobinuria (PNH). Key clinical takeaway: The data obtained confirm that the Biosimilar is not inferior to the Originator in terms of the main efficacy parameter, and is also comparable with it in terms of safety and additional efficacy parameters. Clinicaltrials.gov identifier: NCT04463056.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Annals of hematology, 2021-11-15; N = 16; Rigor 82/100): The data obtained confirm that the Biosimilar is not inferior to the Originator in terms of the main efficacy parameter, and is also comparable with it in terms of safety and additional efficacy parameters. Clinicaltrials.gov identifier: NCT04463056.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: eculizumab → Condition: hydronephrosis → Condition: priapism →
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