Study design and population
large-vessel vasculitis
PMR, GCA
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 52-week study with a 24-week post-treatment follow-up phase (NCT03600805) (Fig. Study design. Patients were included in the study if they had a diagnosis of GCA according to the following criteria: ≥ 50 years of age; history of erythrocyte sedimentation rate (ESR) ≥ 50 mm/h (or C-reactive protein [CRP] > 25 mg/L); unequivocal cranial symptoms of GCA or PMR; and presence of at least one of the following: temporal artery biopsy (TAB) revealing features of GCA, evidence of large-vessel vasculitis by angiography or cross-sectional imaging (angiography, computed tomography angiography [CTA], magnetic resonance angiography [MRA], or positron emission tomography-computed tomography [PET-CT], ultrasound, etc.). Patients either had new-onset active GCA (diagnosis within 6 weeks of baseline) or refractory active GCA (diagnosis > 6 weeks before baseline and previous treatment with ≥ 40 mg/day prednisone [or equivalent] for at least consecutive 2 weeks at a time). The detailed inclusion and exclusion criteria are summarized in Additional file 