The goal of this clinical trial is to evaluate the efficacy and safety of intravenous infusions of burfiralimab (hzVSF-v13) when added to Disease-Modifying Antirheumatic Drug (DMARD) treatment as Standard of Care (SOC) in participants with moderate to severe Rheumatoid Arthritis (RA).
This study is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled. Efficacy and safety of biweekly intravenous infusions of burfiralimab (hzVSF-v13), added to DMARD treatment as standard of care, is evaluated in comparison with placebo. Participants of either sex, aged, 18\~80years, are enrolled it they have moderate to severe RA and had an inadequate response to disease-modifying antirheumatic drug(DMARD) treatments. The study consists of a screening period for up to 4 weeks, a treatment period of 10 weeks. Eligible participants are randomized in a 1:1:1 ratio to 1 of the 3 treatment groups: 200mg burfiralimab (hzVSF-v13) + SOC (study group 1), 600mg burfiralimab (hzVSF-v13) + SOC (study group 2), or placebo + SOC (control group). The primary focus of the study is to evaluate preliminary of the 2 doses of burfiralimab (hzVSF-v13, 200mg to 600mg) administered by IV infusion biweekly for 10 weeks when compared to placebo in lowering disease activity in participants. Efficacy analyses evaluate disease and health-related quality of life improvements at week 12 and week 18. Safety is assessed at up to 18 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Humanized monoclonal antibody.
The following medications listed are allowed to be administered during the course of the clinical study. 1. biologic disease-modifying antirheumatic drug (bDMARD) 2. conventional synthetic disease-modifying antirheumatic drug (csDMARD)
The placebo for Burfiralimab (hzVSF-v13)
University Medical Center Urtrecht
Utrecht, GA, Netherlands
Proportion of participants achieving clinical response according to the ACR 20 criteria at Week 12
Participants who met following 2 conditions for improvement from baseline were classified as meeting the ACR(American College of Rheumatology) 20 response criteria: * ≥ 20% improvement in 66-swollen joint count * ≥ 20% improvement in 68-tender joint count
Time frame: Baseline and Week 12
Clinical response at Week 12, assessed as the attainment of an LDA (Low Disease Activity) state defined
* ACR 50 and ACR 70 * DAS28-CRP \< 3.2 * CDAI (Clinical Disease Activity Index) ≤ 10
Time frame: Baseline and Week 12
Clinical response at Week 12, assessed as remission defined
* DAS28-CRP ≤ 2.6 * CDAI ≤ 2.8
Time frame: Baseline and Week 12
Improvement of physical function at Week 12
* ≥ 0.22 decrease in patient-reported ACR Core Set Values in participant's assessment of physical function using the HAQ-DI (Health Assessment Questionnaire - Disability Index) * \<0.5 in participant's assessment of physical function using the HAQ-DI
Time frame: Baseline and Week 12
Pain relief at Week 12 assessed by the (mean) change from Baseline
\- NRS-11 (11-point numeric scale)
Time frame: Baseline and Week 12
Health-related quality of life at Week 12, assessed as the change from Baseline
EuroQoL (EQ-5D-5L)
Time frame: Baseline and Week 12
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