A Study of Real-World Experience of Psoriasis Patients Treated With Apremilast in Clinical Dermatology Practice

NCT ID: NCT02740218

Last Updated: 2024-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-10-27

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Psoriasis patients

Single cohort of psoriasis patients treated with OTEZLA (apremilast)

Patient questionnaire

Intervention Type OTHER

Patients will be asked to complete a questionnaire regarding their expectations, experience and satisfaction in taking OTEZLA (apremilast) treatment

Interventions

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Patient questionnaire

Patients will be asked to complete a questionnaire regarding their expectations, experience and satisfaction in taking OTEZLA (apremilast) treatment

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Medizinische Universität Graz

Graz, , Austria

Site Status

Praxis Dr. Wolfgang Fuchs

Grosswarasdorf, , Austria

Site Status

Praxis Dr. Schicher

Klagenfurt, , Austria

Site Status

Praxis Dr. Wilhelm

Landeck, , Austria

Site Status

Kepler Universitätsklinikum

Linz, , Austria

Site Status

Praxis Dr. Dunst-Huemer

Linz, , Austria

Site Status

Krankenanstalt Rudolfstiftung

Vienna, , Austria

Site Status

Medizinische Universität Wien

Vienna, , Austria

Site Status

Praxis Dr. Göttfried

Vienna, , Austria

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Praxis Dr. Holub-Hoberger

Vienna, , Austria

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Krankenhaus Hietzing

Vienna, , Austria

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Praxis Dr. Nordberg

Vienna, , Austria

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Praxis Dr. Menzinger

Vienna, , Austria

Site Status

Praxis Dr. Sator

Vienna, , Austria

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Praxis Dr. Perl-Convalexius

Vienna, , Austria

Site Status

Klinikum Wels-Grieskirchen GmbH

Wels, , Austria

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Landesklinikum Wiener Neustadt

Wiener Neustadt, , Austria

Site Status

Klinički bolnički centar Osijek Zavod za dermatologiju i venerologiju

Osijek, , Croatia

Site Status

Klinički bolnički centar Rijeka Klinika za dermatovenerologiju

Rijeka, , Croatia

Site Status

Klinički bolnički centar Split Klinika za kožne i spolne bolesti

Split, , Croatia

Site Status

Klinički bolnički centar Sestre milosrdnice Klinika za kožne i spolne bolest

Zagreb, , Croatia

Site Status

Klinički bolnički centar Zagreb Klinika za dermatovenerologiju

Zagreb, , Croatia

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Fakultní nemocnice Hradec Králové Klinika nemocí kožních a pohlavních

Hradec Králové, Novy Hradec Králové, Czechia

Site Status

Nemocnice Pardubického kraje

Pardubice, Pardubice IV, Czechia

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Sanatorium profesora Arenberger

Prague, Praha 1, Czechia

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Všeobecná fakultní nemocnice v Praze

Prague, Praha 2, Czechia

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Fakultní nemocnice v Motole

Prague, Praha 5, Czechia

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Nemocnice Jihlava příspěvková organizace

Jihlava, , Czechia

Site Status

FN Plzen Bory Dermatovenerologické oddělení

Pilsen, , Czechia

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Company for Medical Study & Service

Selters, Westerwald, Germany

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Praxis Dr. Harst

Aachen, , Germany

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Praxis Dr. Wagner-Schiffler

Aachen, , Germany

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Praxis Dr. Dietz

Ampfing, , Germany

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Praxis Dr. Bell

Andernach, , Germany

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Licca Clinical Research Institute

Augsburg, , Germany

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Gefäß- und Hautzentrum Blaustein

Blaustein, , Germany

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St. Josef und St. Elisabeth Hospital gGmbH

Bochum, , Germany

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Rheinische Friedrich-Wilhelms-Universität Bonn

Bonn, , Germany

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Praxis Dr. Jordan

Brühl, , Germany

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Elbe Klinikum Buxtehude

Buxtehude, , Germany

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Praxis Dr. Schneider

Dachau, , Germany

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Praxis Dr. Thelen

Delmenhorst, , Germany

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Klinikum Dortmund

Dortmund, , Germany

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Praxis Dr. Scheibner

Dresden, , Germany

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Praxis Dr. Korge

Düren, , Germany

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Praxis für Dermatologie und Venerologie, Allergologie

Eltville, , Germany

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Praxis Dr. Schurhammer-Fuhrmann

Endingen, , Germany

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Uniklinikum Erlangen

Erlangen, , Germany

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Praxis Dr. Huerkamp

Euskirchen, , Germany

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Praxis Dr. Swirski

Euskirchen, , Germany

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Universitätsklinikum Frankfurt

Frankfurt, , Germany

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Praxis Dr. Kämmerer

Freiberg, , Germany

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Praxis Dr. Kurzen

Freising, , Germany

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GP Dr. Rotterdam & Kollegen

Gelsenkirchen, , Germany

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Praxis Dr. med W. Klövekorn, Dr. med. A. Tepe, Dr. med. O. Wilde

Gilching, , Germany

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Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

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Praxis Dr. Schmidt

Kusel, , Germany

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Praxis Birgit Zimmermann

Malchow, , Germany

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Praxis Dr. Piontek

Mechernich, , Germany

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Dermatologische Praxis Dr. med. Schwinn

Memmingen, , Germany

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Praxis Büchler

Memmingen, , Germany

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Praxis Dr. Antal

Mühldorf, , Germany

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Praxis Dr. Cords

Mühlheim, , Germany

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Praxis Dr. Liebich

München, , Germany

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Technische Universität München

München, , Germany

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Universitätsklinikum Regensburg

Regensburg, , Germany

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Praxis Dr. Prell

Rosenheim, , Germany

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Praxis Dr. Blank

Rostock, , Germany

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Praxis Dr. Hoene

Rostock, , Germany

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Praxis Dr. Schenkelberger

Sankt Ingbert, , Germany

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Praxis Dr. Neisius

Stolberg, , Germany

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Praxis Dr. Steinborn

Straubing, , Germany

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Universitätsklinikum Tübingen

Tübingen, , Germany

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Gemeinschaftspraxis Dr. Christian Fischer, Florian Kreuziger

Vilshofen, , Germany

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Praxis Dr. Dehmel

Wasserburg am Inn, , Germany

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Praxis Dr. Schmeel

Wesseling, , Germany

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Praxis Dr. Buttgereit

Wildau, , Germany

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Praxis Dr. Süß

Wittlich, , Germany

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Bon Secours Hospital

Tralee, County Kerry, Ireland

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Mater Misericordiae University Hospital

Dublin, , Ireland

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University Hospital Galway

Galway, , Ireland

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Uniiverzitetni klinični center Maribor Oddelek za kožne in spolne bolezni

Maribor, , Slovenia

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Hospital Fundacion Alcorcon, Madrid

Alcorcón, Madrid, Spain

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Vithas Xanit Iinternational Hospital

Benalmádena, , Spain

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Hospital Universitario San Cecilio (PTS)

Granada, , Spain

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Hospital Virgen de la Victoria

Málaga, , Spain

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Hudkliniken Mälarsjukhuset

Eskilstuna, , Sweden

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Hudkliniken SU/ Sahlgrenska

Gothenburg, , Sweden

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Hudmottagningen Karlskoga Lasarett

Karlskoga, , Sweden

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Hudmottagningen Lindesbergs Lasarett

Lindesberg, , Sweden

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Capio Citykliniken Lund

Lund, , Sweden

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Diagnostiskt Centrum Hud Malmö

Malmo, , Sweden

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SUS Malmö Hudkliniken

Malmo, , Sweden

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Hudkliniken Vrinnevisjukhuset Norrköping

Norrköping, , Sweden

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Diagnostiskt Centrum Hud Stockholm

Stockholm, , Sweden

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Cutisgruppen/Stockholm Hud

Stockholm, , Sweden

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Hudkliniken SÖS

Stockholm, , Sweden

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Hudcentrum Hagastaden

Stockholm, , Sweden

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Karolinska Psoriasis Center

Stockholm, , Sweden

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Hudkliniken Danderyds Sjukhus

Stockholm, , Sweden

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Hudmottagningen Trelleborg

Trelleborg, , Sweden

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Hudmottagningen Västervik

Västervik, , Sweden

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Dermatologie Aesche

Basel, , Switzerland

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Somamedica

Basel, , Switzerland

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Ospedale Bellinzona e Valli EOC

Bellinzona, , Switzerland

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Insel Gruppe AG

Bern, , Switzerland

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Clinique dermatologie du Seujet

Geneva, , Switzerland

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Hautarzt Oberaargau AG

Herzogenbuchsee, , Switzerland

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Centre hospitalier universitaire Vaudois (CHUV)

Lausanne, , Switzerland

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Studio medico Dr. Pelloni

Lugano, , Switzerland

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Practice Dr. Niklaus

Martigny-Ville, , Switzerland

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Pallas Klinik Olten

Olten, , Switzerland

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Haut und Laserzentrum Dr. Zuder

Sankt Gallen, , Switzerland

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Praxis Dr. med. Christian Schuster

Sankt Gallen, , Switzerland

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Haut und Allergiezentrum Brunnehof

Uster, , Switzerland

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Dr. Tomi Haut- und Laserzentrum

Weinfelden, , Switzerland

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Hautpraxis Dermateam

Winterthur, , Switzerland

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Praxisgemeinschaft Bünz AG

Wohlen, , Switzerland

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Zug Hautarzt

Zug, , Switzerland

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Universitätsspital Zürich

Zurich, , Switzerland

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Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

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Bradford Teaching Hospitals NHS

Bradford, , United Kingdom

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West Suffolk NHS Foundation

Bury St Edmunds, , United Kingdom

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East Kent & Canterbury Hospital

Canterbury, , United Kingdom

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NHS Dumfries and Galloway

Dumfries, , United Kingdom

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Royal Devon & Exeter NHS Foundation Trust

Exeter, , United Kingdom

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West Middlesex University Hospital

Isleworth, , United Kingdom

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Chapel Allerton Hospital

Leeds, , United Kingdom

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Guy's and St Thomas's NHS Foundation Trust

London, , United Kingdom

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Chelsea & Westminster NHS Foundation Trust

London, , United Kingdom

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Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

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University of Manchester

Salford, , United Kingdom

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Warwick Hospital

Warwick, , United Kingdom

Site Status

Countries

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Austria Croatia Czechia Germany Ireland Slovenia Spain Sweden Switzerland United Kingdom

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 36862361 (View on PubMed)

da Silva Burger N, Tran KV, Typou M, Sommer R, Neasham D, Cordey M, Augustin M. Benefits and Satisfaction with Apremilast Treatment in Patients with Psoriasis Affecting the Genital Area: Secondary Analysis of the APPRECIATE Study. Dermatol Ther (Heidelb). 2025 Mar;15(3):681-695. doi: 10.1007/s13555-025-01360-y. Epub 2025 Feb 19.

Reference Type DERIVED
PMID: 39969771 (View on PubMed)

Jonak C, Gottfried I, Perl-Convalexius S, Gruber B, Schutz-Bergmayr M, Vujic I, Weger W, Schicher N, Semlin L, Hemetsberger M, Cordey M, Sator P. Characteristics and outcomes of patients with psoriasis treated with apremilast in the real-world in Austria - results the APPRECIATE study. Ther Adv Chronic Dis. 2023 Feb 7;14:20406223231152785. doi: 10.1177/20406223231152785. eCollection 2023.

Reference Type DERIVED
PMID: 36777399 (View on PubMed)

Related Links

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Other Identifiers

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CC-10004-PSOR-013

Identifier Type: -

Identifier Source: org_study_id

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