| Autor: |
Kristian Reich, Kilian Eyerich, Knut Schäkel, Peter Weisenseel, Andreas Pinter, Khusru Asadullah, Sven Wegner, Ernesto J Muñoz-Elias, Holger Bartz, Friedmann J H Taut |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
|
| Zdroj: |
BMJ Open, Vol 11, Iss 9 (2021) |
| Druh dokumentu: |
article |
| ISSN: |
2044-6055 |
| DOI: |
10.1136/bmjopen-2021-049822 |
| Popis: |
Background Guselkumab is an interleukin (IL)-23 pathway blocker with proven efficacy in patients with moderate-to-severe plaque psoriasis. Early intervention with guselkumab may result in changes to the clinical disease course versus later intervention.Methods and analysis Here we present the rationale and design of a phase 3b, randomised, double-blind, multicentre study (GUIDE), comparing treatment effects of guselkumab in patients with short (≤2 years) or longer (>2 years) duration of plaque-type psoriasis, measured from first appearance of psoriatic plaques. Participants achieving skin clearance (Psoriasis Area and Severity Index (PASI)=0) by week 20 and maintaining complete clearance at week 28 visit (‘super-responders’ (SRe)) will be randomised to continue approved maintenance dosing every 8 weeks (q8w) versus an investigational maintenance dosing interval of 16 weeks (q16w) until week 68. Primary endpoint: proportion of participants in the q8w vs q16w arms with absolute PASI |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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