PRESTO
Research type
Research Study
Full title
PRESTO – Characterization and clinical outcomes of Alopecia Areata (AA) patients treated with ritlecitinib in a real-world (RW) cohort: A multinational, prospective observational study.
IRAS ID
351818
Contact name
Leila Asfour
Contact email
Sponsor organisation
Pfizer Pharma GmbH
Clinicaltrials.gov Identifier
NCT06531109, http://www.ClinicalTrials.gov
Duration of Study in the UK
2 years, 11 months, 1 days
Research summary
This is a prospective, multi-centre, non-interventional cohort study to evaluate the effectiveness of ritlecitinib in patients aged 12 and older diagnosed with severe Alopecia Areata (AA) and who were prescribed ritlecitinib for their AA in the real-world clinical setting.
The study consists of 96-weeks of follow-up after starting treatment, and an additional 28-day safety follow-up period (only for patients that discontinue ritlecitinib treatment during the study).
Eligible patients will be recruited from hospitals in the United States, Japan, France, China, Italy and the United Kingdom which have experience in managing AA patients. The entire study will enrol approximately 850 patients from approximately 85 sites, with up to 100 patients recruited in the UK.
Patients will attend the study site for scheduled standard of care visits as part of their normal clinical practice and data will be collected accordingly. Patients will be asked to complete patient reported outcomes questionnaires at 24, 48, 72, and 96 weeks after starting ritlecitinib. As this study is observational in nature, if any of the defined assessments are missing, it will not constitute a protocol deviation.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
25/SW/0004
Date of REC Opinion
21 Jan 2025
REC opinion
Favourable Opinion