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Table 1 Study objectives and endpoints

From: Efficacy and safety of guselkumab in biologic-naïve patients with active axial psoriatic arthritis: study protocol for STAR, a phase 4, randomized, double-blinded, placebo-controlled trial

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

  1. AE adverse event, AS ankylosing spondylitis, ASAS40 ≥40% improvement in Assessment of SpondyloArthritis international Society response criteria, ASDAS AS Disease Activity Score utilizing C-reactive protein, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BASDAI50 ≥50% improvement in Bath Ankylosing Spondylitis Disease Activity Index score, CAN-DEN Canada-Denmark, CTCAE 5.0 Common Terminology Criteria for Adverse Events, DAPSA Disease Activity Index for Psoriatic Arthritis, HAQ-DI Health Assessment Questionnaire – Disability Index, IGA Investigator’s Global Assessment, MRI magnetic resonance imaging, OMERACT Outcome Measures in Rheumatology, PK pharmacokinetics, PsA psoriatic arthritis, PsAMRIS Psoriatic Arthritis MRI Scoring System, SAE serious adverse event, SI sacroiliac, SPARCC Spondyloarthritis Research Consortium of Canada
  2. aMultiplicity controlled endpoints that have been identified as important and assess different attributes of disease
  3. bFor this study, the investigator will select the most inflamed hand and the most inflamed foot; the selected hand and foot will be assessed by MRI at baseline, week 24, and week 52