In this 12-month multi-center prospective, site-randomized, two-arm trial, approximately 318 biologic-naïve subjects with RA who are candidates for treatment intensification due to inadequate response to MTX monotherapy will be enrolled at up to 60 study sites.
To determine whether a strategy of Vectra DA guided care (Arm A), compared with usual care (Arm B), achieves non-inferior clinical outcomes while reducing the cost of treatment in patients with active RA and an inadequate response to MTX monotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
318
Change in DAS28 at Month 6
Time frame: Baseline to 6 months
Percentage of subjects using any biologic DMARD or JAK inhibitor to Month 6
Time frame: Baseline to 6 months
Percentage of subjects with ACR20 response at Month 6
Time frame: Baseline to 6 months
Change in HAQ-DI score at Month 6
Time frame: Baseline to 6 months
Percentage of subjects with radiographic non-progression at 12 months
Radiographic non-progression will be defined as change in modified total Sharp score (ΔmTSS) ≤0.5 units from baseline to Month 12
Time frame: Baseline to 12 months
Total cost of RA-related treatment, in US dollars, at Month 6
Time frame: Baseline to 6 months
Total cost of RA-related treatment, in US dollars, at Month 12
Time frame: Baseline to 12 months
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