Inflammatory and immune system, Musculoskeletal Other
Conditions
Interventions
Participants with psoriatic disease who are planned to commence Bimekizumab treatment (a dual IL-17A&F inhibitor) as part of routine NHS standard of care will be recruited and followed prospectively.
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Confirmed diagnosis of Psoriasis or Psoriatic Arthritis, and are eligible and due to start systemic treatment with Bimekizumab as part of routine NHS care 3. Willing and able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Any contraindication to magnetic resonance imaging (MRI) (including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia) or any other disorder which may put the participant at risk 2. Previous IL-17 inhibitor therapy for any indication 3. Regular alcohol intake of >28 units/week and/or a history of binge drinking 4. Patients with known or suspected autoimmune hepatitis, viral hepatitis or Wilson’s disease 5. Participating or planning to participate in another interventional clinical study/trial during the study period that, in the opinion of the investigator, could affect BALANCE outcomes 6. Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the trial, or may influence the participant’s ability to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver cT1 level and Liver proton density fat fraction (PDFF) measured using MRI scans obtained using the CoverScan™ at pre-treatment and 24 weeks post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| MRI biomarkers of fibro-inflammation in heart, lungs, kidneys, pancreas and spleen measured using MRI scans obtained using the CoverScan™ at pre-treatment and 24 weeks post-treatment;Disease activity measures measured using clinical data and patient-reported questionnaire at pre-treatment and 24-weeks post-treatment;Symptoms and quality of life measured using SF-36, DLQI (PsO only), HAQ (PsA only), BASDAI (PsA and axial disease only), PsAID (PsA only), spinal Pain VAS (PsA and axial disease only) at pre-treatment and 24-week post treatment;Effects on the immune system, inflammation, gut bacteria and diet measured using blood and stool samples will be used to study different types of immune cells, inflammatory markers and genetic material from gut bacteria. Participants will also complete a questionnaire about their diet at pre-treatment and 24-week post treatment | — |
Countries
England, United Kingdom
Contacts
Public Contact- BALANCE Trial Manager
Outcome results
None listed