STAR: Guselkumab in Psoriatic Arthritis Axial Disease
Research type
Research Study
Full title
A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants with Active Psoriatic Arthritis Axial Disease
IRAS ID
302259
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-000465-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 16 days
Research summary
This is a research study in 405 adults with Psoriatic Arthritis Axial Disease (PsA).
PsA is an inflammatory joint disease affecting a variety of joints causing them to become swollen resulting in stiffness, pain and lack of movement in the affected areas. Axial Disease, is a type inflammation primarily affecting the spine and sacroiliac joints (which connect the lower spine to the pelvis), which results in pain in the lower back, hips, and buttocks. About half the patients with PSA have axial disease, although some do not always present with symptoms, despite it being seen on imaging scans.
The Investigational study drug is called Guselkumab (marketed as TREMFYA) and is licensed for the treatment of plaque psoriasis and psoriatic arthritis. Previous studies have shown that treatment with Guselkumab has demonstrated improvement in axial symptoms in a subset of patients with PSA, and so this study is designed to test whether the study drug is safe and effective in treating PSA Axial Disease both in terms of reducing symptoms and in reducing visible inflammation on the imaging scans.
This study will last for a maximum of 66 weeks and is divided into 3 parts:
Screening Phase: 1 or more visits (upto 6 weeks)
Treatment Phase: 14 visits (52 weeks)
Safety Follow-Up Phase: 1 visit (8 weeks)During study visits a variety of tests will be carried out including, but not limited to, BP, ECG, physical exam, chest x-ray, MRI Scans, questionnaires and blood samples. Patients will be randomly assigned to receive either Guselkumab 100mmg 4-weekly, Guselkumab 100mg 8-weekly or Placebo for the first 24 weeks. After Week 24, all patients will receive Guselkumab until the end of the treatment phase. If at week 16, a participant is showing <10% improvement from baseline then there is an option to initiate/increase the dose of an allowed concomitant medication.
REC name
London - Hampstead Research Ethics Committee
REC reference
21/LO/0627
Date of REC Opinion
15 Oct 2021
REC opinion
Further Information Favourable Opinion