Clinical trial NCT02740218: A Study of Real-World Experience of Psoriasis Patients Treated With Apremilast in Clinical Dermatology Practice
Official title: APPRECIATE (Apremilast Clinical Treatment Experience in Psoriasis): A Multi-center, Retrospective Observational Study of Real-World Experience of Psoriasis Patients Treated With Apremilast in Clinical Dermatology Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
Apremilast
APPRECIATE
Dermatology
Retrospective
Observational
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient charts will be selected for data abstraction by participating dermatologists and will be determined eligible for study enrollment based on the inclusion criteria. All consecutive adult psoriasis patients who can be contacted 6 months (+/- 1 month) following initiation of treatment with apremilast will be approached for entry to minimize bias in patient selection. All eligible patients will be included in consecutive order regarding the date of the signed Informed Consent.

Brief summary: This is a retrospective, multi-center observational cohort study. This study will be implemented first in Germany (approximately 50 sites), the United Kingdom (approximately 20 sites) and Sweden (approximately 25 sites), followed by a selected number of countries in Europe, depending on apremilast local availability. The design of this apremilast retrospective study aims to provide clinical information regarding the treatment initiation and outcomes in psoriasis patients when prescribed apremilast in real world settings. In addition, this study is aiming at capturing physicians' and patients' treatment goals when initiating apremilast and whether these goals are achieved following apremilast use. This study is primarily descriptive in nature, and no a priori hypotheses are specified. Patients must voluntarily sign an informed consent form, be 18 or over, have been diagnosed with plaque psoriasis and have been treated with apremilast during the previous 5-7 months to participate in this study. They must not be involved in any other clinical study involving apremilast.


Eligibility criteria: Inclusion Criteria:

1. Must have understood and voluntarily signed the Informed Consent Form (ICF).
2. Age ≥ 18 years at the time of signing the ICF.
3. Diagnosed with plaque psoriasis.
4. Initiated treatment with apremilast 6 months (+/- 1 month) previously (patients may or may not have completed 6 months of apremilast treatment)

Exclusion Criteria:

1. Refusal to participate in this study or current participation in the treatment phase of an interventional clinical trial.
2. Started apremilast as part of a clinical trial.

Primary outcomes:
measure: The Patient Benefit Index (PBI) outcome score
timeFrame: Up to approximately 7 months
Secondary outcomes:
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score
timeFrame: Up to approximately 7 months
measure: Percentage of patients achieving PASI75
timeFrame: Up to approximately 7 months
measure: Percentages of patients achieving PASI50
timeFrame: Up to approximately 7 months
measure: Mean change in Dermatology Life Quality Index (DLQI)
timeFrame: Up to approximately 7 months
measure: Percentages of patients achieving ≥5 point improvement in DLQI
timeFrame: Up to approximately 7 months
measure: Percentages of patients achieving PASI50 plus ≥5 point improvement in DLQI
timeFrame: Up to approximately 7 months
measure: Mean change in Body Surface Area (BSA)
timeFrame: Up to approximately 7 months
measure: Mean change in PGA
timeFrame: Up to approximately 7 months
measure: Percentage of patients achieving PGA 0/1 (clear/almost clear)
timeFrame: Up to approximately 7 months
measure: Adverse Events (AEs)
timeFrame: Up to approximately 7 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Großwarasdorf
country: Austria
facility: Praxis Dr. Wolfgang Fuchs
city: Klagenfurt
country: Austria
facility: Praxis Dr. Schicher
city: Landeck
country: Austria
facility: Praxis Dr. Wilhelm
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Linz
country: Austria
facility: Praxis Dr. Dunst-Huemer
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wiener Neustadt
city: Wien
country: Austria
facility: Krankenanstalt Rudolfstiftung
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Wien
country: Austria
facility: Praxis Dr. Göttfried
city: Wien
country: Austria
facility: Praxis Dr. Holub-Hoberger
city: Wien
country: Austria
facility: Krankenhaus Hietzing
city: Wien
country: Austria
facility: Praxis Dr. Nordberg
city: Wien
country: Austria
facility: Praxis Dr. Menzinger
city: Wien
country: Austria
facility: Praxis Dr. Sator
city: Wien
country: Austria
facility: Praxis Dr. Perl-Convalexius
city: Osijek
country: Croatia
facility: Klinički bolnički centar Osijek Zavod za dermatologiju i venerologiju
city: Rijeka
country: Croatia
facility: Klinički bolnički centar Rijeka Klinika za dermatovenerologiju
city: Split
country: Croatia
facility: Klinički bolnički centar Split Klinika za kožne i spolne bolesti
city: Zagreb
country: Croatia
facility: Klinički bolnički centar Sestre milosrdnice Klinika za kožne i spolne bolest
city: Zagreb
country: Croatia
facility: Klinički bolnički centar Zagreb Klinika za dermatovenerologiju
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové Klinika nemocí kožních a pohlavních
state: Novy Hradec Králové
city: Pardubice
country: Czechia
facility: Nemocnice Pardubického kraje
state: Pardubice IV
city: Praha
country: Czechia
facility: Sanatorium profesora Arenberger
state: Praha 1
city: Praha
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
state: Praha 2
city: Praha
country: Czechia
facility: Fakultní nemocnice v Motole
state: Praha 5
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava příspěvková organizace
city: Plzen
country: Czechia
facility: FN Plzen Bory Dermatovenerologické oddělení
city: Selters
country: Germany
facility: Company for Medical Study & Service
state: Westerwald
city: Aachen
country: Germany
facility: Praxis Dr. Harst
city: Aachen
country: Germany
facility: Praxis Dr. Wagner-Schiffler
city: Ampfing
country: Germany
facility: Praxis Dr. Dietz
city: Andernach
country: Germany
facility: Praxis Dr. Bell
city: Augsburg
country: Germany
facility: Licca Clinical Research Institute
city: Blaustein
country: Germany
facility: Gefäß- und Hautzentrum Blaustein
city: Bochum
country: Germany
facility: St. Josef und St. Elisabeth Hospital gGmbH
city: Bonn
country: Germany
facility: Rheinische Friedrich-Wilhelms-Universität Bonn
city: Brühl
country: Germany
facility: Praxis Dr. Jordan
city: Buxtehude
country: Germany
facility: Elbe Klinikum Buxtehude
city: Dachau
country: Germany
facility: Praxis Dr. Schneider
city: Delmenhorst
country: Germany
facility: Praxis Dr. Thelen
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Dresden
country: Germany
facility: Praxis Dr. Scheibner
city: Düren
country: Germany
facility: Praxis Dr. Korge
city: Eltville
country: Germany
facility: Praxis für Dermatologie und Venerologie, Allergologie
city: Endingen
country: Germany
facility: Praxis Dr. Schurhammer-Fuhrmann
city: Erlangen
country: Germany
facility: Uniklinikum Erlangen
city: Euskirchen
country: Germany
facility: Praxis Dr. Huerkamp
city: Euskirchen
country: Germany
facility: Praxis Dr. Swirski
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Freiberg
country: Germany
facility: Praxis Dr. Kämmerer
city: Freising
country: Germany
facility: Praxis Dr. Kurzen
city: Gelsenkirchen
country: Germany
facility: GP Dr. Rotterdam & Kollegen
city: Gilching
country: Germany
facility: Praxis Dr. med W. Klövekorn, Dr. med. A. Tepe, Dr. med. O. Wilde
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Kusel
country: Germany
facility: Praxis Dr. Schmidt
city: Malchow
country: Germany
facility: Praxis Birgit Zimmermann
city: Mechernich
country: Germany
facility: Praxis Dr. Piontek
city: Memmingen
country: Germany
facility: Dermatologische Praxis Dr. med. Schwinn
city: Memmingen
country: Germany
facility: Praxis Büchler
city: Mühldorf
country: Germany
facility: Praxis Dr. Antal
city: Mühlheim
country: Germany
facility: Praxis Dr. Cords
city: München
country: Germany
facility: Praxis Dr. Liebich
city: München
country: Germany
facility: Technische Universität München
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Rosenheim
country: Germany
facility: Praxis Dr. Prell
city: Rostock
country: Germany
facility: Praxis Dr. Blank
city: Rostock
country: Germany
facility: Praxis Dr. Hoene
city: Sankt Ingbert
country: Germany
facility: Praxis Dr. Schenkelberger
city: Stolberg
country: Germany
facility: Praxis Dr. Neisius
city: Straubing
country: Germany
facility: Praxis Dr. Steinborn
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Vilshofen
country: Germany
facility: Gemeinschaftspraxis Dr. Christian Fischer, Florian Kreuziger
city: Wasserburg am Inn
country: Germany
facility: Praxis Dr. Dehmel
city: Wesseling
country: Germany
facility: Praxis Dr. Schmeel
city: Wildau
country: Germany
facility: Praxis Dr. Buttgereit
city: Wittlich
country: Germany
facility: Praxis Dr. Süß
city: Tralee
country: Ireland
facility: Bon Secours Hospital
state: County Kerry
city: Dublin 7
country: Ireland
facility: Mater Misericordiae University Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Maribor
country: Slovenia
facility: Uniiverzitetni klinični center Maribor Oddelek za kožne in spolne bolezni
city: Alcorcón
country: Spain
facility: Hospital Fundacion Alcorcon, Madrid
state: Madrid
city: Benalmádena
country: Spain
facility: Vithas Xanit Iinternational Hospital
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio (PTS)
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Eskilstuna
country: Sweden
facility: Hudkliniken Mälarsjukhuset
city: Göteborg
country: Sweden
facility: Hudkliniken SU/ Sahlgrenska
city: Karlskoga
country: Sweden
facility: Hudmottagningen Karlskoga Lasarett
city: Lindesberg
country: Sweden
facility: Hudmottagningen Lindesbergs Lasarett
city: Lund
country: Sweden
facility: Capio Citykliniken Lund
city: Malmö
country: Sweden
facility: Diagnostiskt Centrum Hud Malmö
city: Malmö
country: Sweden
facility: SUS Malmö Hudkliniken
city: Norrköping
country: Sweden
facility: Hudkliniken Vrinnevisjukhuset Norrköping
city: Stockholm
country: Sweden
facility: Diagnostiskt Centrum Hud Stockholm
city: Stockholm
country: Sweden
facility: Cutisgruppen/Stockholm Hud
city: Stockholm
country: Sweden
facility: Hudkliniken SÖS
city: Stockholm
country: Sweden
facility: Hudcentrum Hagastaden
city: Stockholm
country: Sweden
facility: Karolinska Psoriasis Center
city: Stockholm
country: Sweden
facility: Hudkliniken Danderyds Sjukhus
city: Trelleborg
country: Sweden
facility: Hudmottagningen Trelleborg
city: Västervik
country: Sweden
facility: Hudmottagningen Västervik
city: Basel
country: Switzerland
facility: Dermatologie Aesche
city: Basel
country: Switzerland
facility: Somamedica
city: Bellinzona
country: Switzerland
facility: Ospedale Bellinzona e Valli EOC
city: Bern
country: Switzerland
facility: Insel Gruppe AG
city: Genève
country: Switzerland
facility: Clinique dermatologie du Seujet
city: Herzogenbuchsee
country: Switzerland
facility: Hautarzt Oberaargau AG
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire Vaudois (CHUV)
city: Lugano
country: Switzerland
facility: Studio medico Dr. Pelloni
city: Martigny
country: Switzerland
facility: Practice Dr. Niklaus
city: Olten
country: Switzerland
facility: Pallas Klinik Olten
city: St. Gallen
country: Switzerland
facility: Haut und Laserzentrum Dr. Zuder
city: St. Gallen
country: Switzerland
facility: Praxis Dr. med. Christian Schuster
city: Uster
country: Switzerland
facility: Haut und Allergiezentrum Brunnehof
city: Weinfelden
country: Switzerland
facility: Dr. Tomi Haut- und Laserzentrum
city: Winterthur
country: Switzerland
facility: Hautpraxis Dermateam
city: Wohlen
country: Switzerland
facility: Praxisgemeinschaft Bünz AG
city: Zug
country: Switzerland
facility: Zug Hautarzt
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS
city: Bury St Edmunds
country: United Kingdom
facility: West Suffolk NHS Foundation
city: Canterbury
country: United Kingdom
facility: East Kent & Canterbury Hospital
city: Dumfries
country: United Kingdom
facility: NHS Dumfries and Galloway
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter NHS Foundation Trust
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas's NHS Foundation Trust
city: London
country: United Kingdom
facility: Chelsea & Westminster NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Salford
country: United Kingdom
facility: University of Manchester
city: Warwick
country: United Kingdom
facility: Warwick Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Pedro Herranza, Lidia Trasobaresb, Almudena Mateuc, Esperanza Martínezd, Ricardo Ruiz-Villaverdee, Ofelia Baniandrésf, Javier Mataixg, Natalia Jiménez-Gómezh, Marta Serrai, Diana Patricia Ruiz Genaoj, Noelia Riverak, Jesús Tercedor-Sánchezl, Carmen Garciam, Myriam Cordeyn, Enrique Herrera-Acostao. Characterization and outcomes of patients treated with apremilast in the Spanish routine clinical practice: Results from the APPRECIATE study. Actas Dermosifiliogr.
citation: Cetkovska P, Dediol I, Sola M, Kojanova M, Trcko K, Carija A, Ceovic R, Ledic-Drvar D, Kastelan M, Hrabar A, Missoup MC, Mamun K. Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe. Adv Ther. 2023 Apr;40(4):1787-1802. doi: 10.1007/s12325-023-02468-3. Epub 2023 Mar 2.