Brief report: enhancement of patient recruitment in rheumatoid arthritis clinical trials using a multi-biomarker disease activity score as an inclusion criterion.
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Objective Rheumatoid arthritis (RA) clinical trials often exclude patients with low C-reactive protein (CRP), slowing trial enrollment. We evaluated whether RA patients with a high multi-biomarker disease activity (MBDA) score (>44) among those with low CRP (≤10 mg/L) could complement patients with CRP >10mg/L to enhance patient recruitment without affecting clinical trial outcomes. Methods We evaluated patients from the Swedish pharmacotherapy (SWEFOT) trial, which had no CRP selection criteria. Clinical outcomes were assessed after 3 months of methotrexate (MTX) monotherapy for MTX-naïve patients (N=220) and after add-on therapy from Months 3 to 12 for MTX-inadequate responder (IR) patients (N=127). Radiographic outcomes were assessed at 1 year for all patients. Within each cohort, outcomes were compared between patients with CRP ≤10 mg/L and MBDA score >44 at the start of the respective treatment interval versus those with CRP >10 mg/L. Results Patients with baseline CRP ≤10 mg/L and MBDA score >44 at baseline had comparable clinical and radiographic outcomes to those for patients with CRP>10 mg/L. This broadened definition of inclusion criteria identified an additional 24% MTX-naïve and 47% MTX-IR patients. Conclusion Patient recruitment of RA clinical trials may be substantially enhanced by using "CRP >10 mg/L and/or MBDA score >44" as an inclusion criterion, without diminishing clinical or radiographic outcomes. This article is protected by copyright. All rights reserved.
|Research areas and keywords||
Subject classification (UKÄ) – MANDATORY
|Journal||Arthritis & Rheumatology|
|Publication status||Published - 2015|
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