CAIN457A3403 (SERENA) Secukinumab real-life use in Pso, PsA and AS
Research type
Research Study
Full title
Long-term observational, prospective study to collect in a real life setting data on the retention, effectiveness, safety, treatment pattern, quality of life, and efficiency of secukinumab in adult patients with moderate to severe plaque psoriasis, psoriatic arthritis or ankylosing spondylitis
IRAS ID
218606
Contact name
Yusuf Patel
Contact email
Sponsor organisation
Novartis Pharma AG
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Novartis is conducting this non-interventional study called SERENA to assess moderate to severe plaque psoriasis, psoriatic arthritis (PsA) or ankylosing spondylitis (AS) patients who have been prescribed Secukinumab (Cosentyx®) for the treatment of their disease. As this is a non-interventional study, patients are only observed and certain outcomes are measured. The primary outcome observed will be treatment retention, to investigate how long patients are taking Secukinumab and what the reasons are to stop or change this treatment. This allows for assessing how doctors prescribe Cosentyx®, how patients take it, but also how well the treatment works in patients with Pso, PsA or AS, and how well patients tolerate the treatment.
Approximately 5000 patients across Europe will participate in the study. Approximately 250 of these patients will be recruited from sites in the UK. The study recruited its first patient 14th October 2016 at a site in Belgium. The last patient last visit for the study is expected 25th March 2022.
Summary of study results:
A lay summary will not be published. Plain Language Trial Summary (PLTS) is not applicable for this study, per Novartis SOPs.
REC name
East of England - Essex Research Ethics Committee
REC reference
17/EE/0196
Date of REC Opinion
25 May 2017
REC opinion
Further Information Favourable Opinion