Prose - Cosentyx®/Secukinumab/AIN457
Research type
Research Study
Full title
An open-label, prospective, non-randomized, multicenter study to evaluate clear skin effect on health-related quality of life outcomes at 16 and 52 weeks in patients with moderate to severe plaque psoriasis treated with secukinumab 300 mg s.c. with or without previous exposure to systemic therapy
IRAS ID
199083
Contact name
Andrew Wright
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2015-003701-42
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The purpose of this study is to assess the effect of treatment with secukinumab on patient quality of life over 16 and 52 weeks. In particular, there will be an evaluation of whether the effect on quality of life is different in patients who received different types of treatment before starting secukinumab, i.e. patients who received no prior systemic treatment, patients who received prior treatment with a non-biologic systemic treatment, and patients who received prior treatment with a biologic systemic treatment for psoriasis.
Quality of life will be assessed using a combination of dermatology-related, general health-related and psoriasis-related questionnaires most of which will be completed by the patient and some by a family member. The choice of quality of life questionnaires was discussed and agreed with dermatologist and patient representatives.
The study will also explore whether the presence of other diseases; duration of disease; localization of psoriasis plaques; and concomitant treatment with topical psoriasis treatment alter the effects of secukinumab.REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/0240
Date of REC Opinion
3 Mar 2016
REC opinion
Further Information Favourable Opinion