✓ Translated by DotMD AI Clinical Council Source: Clinical and experimental rheumatology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #39808286 ↗

Phase III Randomized Trial: A Phase 3, 56-week, randomised, double-blind, placebo-controlled study (OA-11) utilising patient-reported and radiographic outcomes evaluating the efficacy and safety of a lorecivivint injection in patients with moderate to severe knee osteoarthritis (N = 513)

Original Paper Title: “A Phase 3, 56-week, randomised, double-blind, placebo-controlled study (OA-11) utilising patient-reported and radiographic outcomes evaluating the efficacy and safety of a lorecivivint injection in patients with moderate to severe knee osteoarthritis”

Elena Rostova (AI Quant) Rigor Score
93 / 100
Sample Size (Participants)
N = 513
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • 513 patients were randomised. Baseline mean medial JSW was 2.61 (±0.7) mm. The mean change from baseline in weekly average of daily Pain NRS at Week 12 was LOR -2.24 (± 0.13) compared with PBO -2.49 (± 0.13); p=0.185, 95% confidence interval (CI) (-0.12, 0.62).
  • Study Design & Sample: Phase III Randomized Trial published in Clinical and experimental rheumatology (N = 513 human participants).
  • Biostatistical Rigor Score: 93/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Clinical and experimental rheumatology (2025), this phase iii randomized trial evaluating 513 human participants investigated: To determine the efficacy, safety, and tolerability of intraarticular (IA) lorecivivint (LOR) in the treatment of knee osteoarthritis (OA). Key clinical takeaway: 513 patients were randomised. Baseline mean medial JSW was 2.61 (±0.7) mm. The mean change from baseline in weekly average of daily Pain NRS at Week 12 was LOR -2.24 (± 0.13) compared with PBO -2.49 (± 0.13); p=0.185, 95% confidence interval (CI) (-0.12, 0.62).

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

Primary Endpoint & Quantitative Summary (Clinical and experimental rheumatology, 2025-05-15; N = 513; Rigor 93/100): 513 patients were randomised. Baseline mean medial JSW was 2.61 (±0.7) mm. The mean change from baseline in weekly average of daily Pain NRS at Week 12 was LOR -2.24 (± 0.13) compared with PBO -2.49 (± 0.13); p=0.185, 95% confidence interval (CI) (-0.12, 0.62).

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.

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