✓ Translated by DotMD AI Clinical Council Source: Modern rheumatology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #39657989 ↗

Phase III Randomized Trial: Laboratory markers predicting tofacitinib efficacy in Japanese patients with rheumatoid arthritis: A pooled analysis of Phase 2/3 randomised controlled clinical trials (N = 467)

Original Paper Title: “Laboratory markers predicting tofacitinib efficacy in Japanese patients with rheumatoid arthritis: A pooled analysis of Phase 2/3 randomised controlled clinical trials”

Elena Rostova (AI Quant) Rigor Score
93 / 100
Sample Size (Participants)
N = 467
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Changes in laboratory parameters at M1 could potentially be used to assess whether tofacitinib therapy will be effective at M3; however, further investigation is needed.
  • Study Design & Sample: Phase III Randomized Trial published in Modern rheumatology (N = 467 human participants).
  • Biostatistical Rigor Score: 93/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Modern rheumatology (2025), this phase iii randomized trial evaluating 467 human participants investigated: We characterised early changes in laboratory parameters in Japanese patients with rheumatoid arthritis and assessed whether these changes at Month (M)1 were predictive of tofacitinib efficacy at M3. Key clinical takeaway: Changes in laboratory parameters at M1 could potentially be used to assess whether tofacitinib therapy will be effective at M3; however, further investigation is needed.

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

Primary Endpoint & Quantitative Summary (Modern rheumatology, 2025-04-08; N = 467; Rigor 93/100): Changes in laboratory parameters at M1 could potentially be used to assess whether tofacitinib therapy will be effective at M3; however, further investigation is needed.

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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