Dear All,
We are currently looking for statistician to take a role on the oversight committee for the SATURN study.
Details are given below, if you are interested please contact either [log in to unmask]<mailto:[log in to unmask]> or [log in to unmask]<mailto:[log in to unmask]> for more details.
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.
Phase: Phase 2 CTIMP
Sample Size: 25 Patients plus 10 healthy controls ae to be enrolled on the study.
Randomisation: Patients will be randomised in ration of 4:1 to ARM A – secukinumab + standard DMARD therapy (20 patients) or ARM B – Standard DMARD therapy (5 patients)
Main Inclusion Criteria: For both Arms patients with active psoriatic arthritis (fulfilling CASPAR criteria) affecting > 2 peripheral joints (swollen and tender) that have not responded to at least two standard DMARDS
Main Exclusion Criteria: Active or chronic infection including mycobacterium tuberculosis, Absence of active psoriatic arthritis, Patients who are startin Anti-TNF therapy for treating PsA, Pregnancy or planning conception or pregnancy, Malignancy and significant comorbity that, in the opinion of the investigator, would impact on ability to participate.
Number of Sites: 1
Study Duration: 24 months in total with 12 months of therapy, and 12 months for staggered enrolment and laboratory investigations.
Primary Aim: To determine the molecular effects of IL-17 and inhibition of IL-17 with secukinumab on neutrophil phenotype, lifespan, function and production of IL-17
Dr Richard Jackson
Senior Statistician
Cancer Research UK Liverpool Cancer Trials Unit
University of Liverpool
1st floor Block C, Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
Tel: +44(0)151 794 8834
Fax: +44(0)151 794 8930/8931
Email: [log in to unmask]<mailto:[log in to unmask]>.uk
Web: http://www.lctu.org.uk<http://www.lctu.org.uk/>
http://www.liv.ac.uk/cancerstudies/CRUK_centre.htm
http://www.lctu.org.uk/lecmc/
http://www.liv.ac.uk/Surgery/
[cid:E382F07A-2234-413E-AF65-DA47ABA74A80@liv.ac.uk]
