NCT02559622

Trial name or title	Evaluation of cardiovascular risk markers in psoriasis patients treated with secukinumab (CARIMA)
Methods	RCT, placebo‐controlled, double‐blind study Date of study: September 2015 ‐ Location: Germany Phase 4
Participants	Randomised: 151 participants Key inclusion criteria Chronic moderate‐severe plaque type psoriasis for ≥ 6 months prior to randomisation with a PASI score ≥ 10 at randomisation Inadequate response, intolerance or contraindication to ciclosporin, methotrexate and psoralen plus ultraviolet A light treatment (PUVA) as documented in the patient's medical history or reported by the patient or determined by the investigator at screening. Relative contraindications such as interference of patient's lifestyle with the treatment are accepted Key exclusion criteria Forms of psoriasis other than chronic plaque‐type (e.g. pustular, erythrodermic and guttata psoriasis) at screening or randomisation Ongoing use of prohibited psoriasis and non‐psoriasis treatments. Washout periods have to be adhered to
Interventions	Intervention Secukinumab 300 (300 mg every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48) Control interventions Secukinumab 150 (150 mg every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48) Placebo
Outcomes	At week 12, Primary outcome Flow Mediated Dilation (FMD) Secondary outcomes Aortic Augmentation Index at heart rate of 75 Pulse wave velocity Biomarkers PASI IGA
Starting date	April 2014
Contact information	Novartis Pharmaceuticals
Notes	On ClinicalTrials.gov, Primary completion date: April 2016 (final data collection date for primary outcome measure) Still ongoing