A Phase 2a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Burfiralimab (hzVSF-v13) added to disease-modifying antirheumatic drugs in patient with moderate to severe Rheumatoid Arthritis

rheumatoid arthritis

Proportion of participants achieving clinical response according to the American College of Rheumatology (ACR) 20 criteria at Week 12

Clinical response at Week 12, assessed as the percentage of participants achieving low disease activity (LDA) as measured by: o ACR50 (70) = 50% (70%) improvement in the ACR core set values o Disease Activity Score 28 for Rheumatoid Arthritis with C-reactive protein (DAS28-CRP) <3.2 o Clinical Disease Activity Index (CDAI) ≤10, Clinical response at Week 12, assessed as the percentage of participants attaining remission as measured by: o DAS28-CRP ≤2.6 o CDAI ≤2.8, Clinical response at Week 12, assessed as (mean) change from Baseline in: o DAS28-CRP o CDAI, Clinical response at Week 12, assessed as the (mean) hybrid ACR score, Improvement in physical function at Week 12, assessed as the percentage of participants with: o A ≥0.22 decrease in patient reported ACR Core Set Values in participant’s assessment of physical function using Health Assessment Questionnaire-Disability Index (HAQ-DI) o A <0.5 in participant’s assessment of physical function using the HAQ DI, Pain relief at Week 12, assessed by the (mean) change from Baseline of the 11 point numeric scale (NRS 11), Health-related quality of life at Week 12 as assessed by (mean) change from baseline of the EQ-5D-5L Health Questionnaire (EuroQoL)

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