SAIL NIS Study M/14745/43
Research type
Research Study
Full title
Observational study to assess the effectiveness, safety profile and real-life prescribing and utilization patterns of tildrakizumab (Ilumetri®) in patients with moderate to severe plaque psoriasis in routine clinical practice.
IRAS ID
271893
Contact name
Agustin Martin-Clavijo
Contact email
Sponsor organisation
Almirall S.A.
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Psoriasis is a chronic immune mediated disease affecting the skin and joints. It affects an estimated 7.8 million adults in Europe and approximately 125 million people worldwide. It is a non-contagious disorder that accelerates the growth cycle of skin cells and results in thickening and scaling of skin areas. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed. Despite different treatment options existing, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease. Tildrakizumab (a monoclonal antibody) was approved by the European Medicines Agency on September 2018 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Therefore, this study will provide the opportunity to continue the follow-up of these patients (cohort 1) treated for more than 4 years in clinical trials providing long-term data. In addition, the study will help to confirm the efficacy, maintenance of response and safety profile on new patients (cohort 2) over 18 years of age diagnosed with severe chronic plaque psoriasis in routine clinical practice. The decision to prescribe Tildrakizumab for a particular patient is made exclusively by the physician and is therefore NOT made in advance by the Observation Plan, but is subject to medical practice. In this study, the visit structure is not defined by the study protocol, but is driven by routine clinical practice in accordance to the SmPC. Ideally, the visit structure would include roughly 10 visits over 2 years. During that time, patients will be asked to complete a variety of standardised Questionnaires. The study will be performed at approximately 76 study sites across seven European countries including the UK.
REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/0454
Date of REC Opinion
14 Apr 2020
REC opinion
Further Information Favourable Opinion