SATURN: Effect of Secukinumab in the treatment of psoriatic arthritis
Research type
Research Study
Full title
SATURN: An exploration of the dynamic interaction between IL-17, IL-17 inhibition with (secukinumab) and neutrophils in psoriatic arthritis in vitro and ex vivo with exploratory study on the potential role of Vitamin D
IRAS ID
189178
Contact name
ROBERT MOOTS
Contact email
Sponsor organisation
University of Liverpool
Eudract number
2015-004502-42
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
This research is being carried out to investigate the effects of a drug called secukinumab on patients with psoriatic arthritis. The study will also look at (1) the effect this drug has on vitamin D levels in the blood, (2) white blood cell involvement (cells that are important in protecting and fighting infection), as we already know that these cells play an important role in causing diseases such as psoriatic arthritis, (3) comparing and contrasting white blood cells in patients with psoriatic arthritis to those from healthy controls and (4) examine whether there is a relationship between vitamin D and cytokine (these are small proteins that help cells communicate with each other) levels.
The main patient inclusion criteria are; active psoriatic arthritis, aged 18 years and over and previously responded to at least two standard DMARDs.
We aim to recruit 25 patients and 10 healthy controls. There will be 2 patient groups and 1 healthy control group. Patient groups will be allocated to either Arm A - Secukinumab will be 150mg subcutaneous injection once weekly for the first 4 weeks then 4 weekly for up to 11 months plus DMARD therapy or Arm B - Patients will continue to take standard DMARD therapy. Healthy controls will provide one 30 ml blood sample (equivalent to 6 teaspoons).
The study will be conducted as a single sit at the Rheumatology clinic at University Hospital Aintree, Liverpool.
The study duration is 24 months total, 12 months of therapy for patients and 12 months for staggered recruitment and laboratory investigations.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0006
Date of REC Opinion
10 Feb 2016
REC opinion
Further Information Favourable Opinion