Objectives | Endpoints |
---|---|
Primary | |
• To evaluate the efficacy of guselkumab treatment in patients with active PsA axial disease by assessing reduction in axial symptoms | Mean change from baseline in BASDAI at week 24a |
Major secondary | |
• To evaluate the efficacy of guselkumab on additional measures of axial symptoms, reduction in axial inflammation, and other signs and symptoms of PsA, psoriasis, and patient well-being | Mean change from baseline at week 24 in: • ASDASa • DAPSA scorea • HAQ-DI scorea • SPARCC score for MRI SI joints (among patients with positive MRI of SI joints at baseline)a • SPARCC score for MRI spine (among patients with positive spinal MRI at baseline) At week 24, proportion of patients achieving: • BASDAI50 response • ASDAS clinically important improvement (change ≥ 1.1) • ASDAS major improvement (change ≥ 2.0) • ASDAS inactive disease (score < 1.3) • ASAS40 response • IGA 0/1 response (among patients with ≥ 3% body surface area affected with psoriasis involvement at baseline)a |
Other secondary | |
• To evaluate the safety of guselkumab in patients with active PsA | For the duration of the study, through week 60: • Frequency and type of AEs, SAEs, AEs leading to discontinuation of study intervention, infections, and injection-site reactions • Frequency of laboratory abnormalities (chemistry, hematology) maximum toxicity (Common Terminology Criteria for Adverse Events [CTCAE 5.0]) grades |
• To evaluate the PK and immunogenicity of guselkumab in patients with active PsA | Through week 60: • Mean/median serum guselkumab concentrations over time • Incidence of antibodies to guselkumab |
Additional assessments | |
Mean change from baseline through week 52 in: • CAN-DEN score for spine MRI (among patients with baseline CAN-DEN score ≥ 3) • OMERACT PsAMRIS score for MRI of the hands and feet (exploratory analysis in a subset of patients) by visitb |