NCT02740218

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
610

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
10 countries

133 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2021

Completed
Last Updated

March 4, 2024

Status Verified

March 1, 2024

Enrollment Period

5.3 years

First QC Date

April 12, 2016

Last Update Submit

March 1, 2024

Conditions

Keywords

PsoriasisApremilastAPPRECIATEDermatologyRetrospectiveObservational

Outcome Measures

Primary Outcomes (1)

  • The Patient Benefit Index (PBI) outcome score

    Is a questionnaire regarding patient expectations and benefit of psoriasis treatment with apremilast, eg, effect on specific symptoms.

    Up to approximately 7 months

Secondary Outcomes (10)

  • Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score

    Up to approximately 7 months

  • Percentage of patients achieving PASI75

    Up to approximately 7 months

  • Percentages of patients achieving PASI50

    Up to approximately 7 months

  • Mean change in Dermatology Life Quality Index (DLQI)

    Up to approximately 7 months

  • Percentages of patients achieving ≥5 point improvement in DLQI

    Up to approximately 7 months

  • +5 more secondary outcomes

Study Arms (1)

Psoriasis patients

Single cohort of psoriasis patients treated with OTEZLA (apremilast)

Other: Patient questionnaire

Interventions

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

Psoriasis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (133)

Medizinische Universität Graz

Graz, 8036, Austria

Location

Praxis Dr. Wolfgang Fuchs

Grosswarasdorf, 7304, Austria

Location

Praxis Dr. Schicher

Klagenfurt, 9020, Austria

Location

Praxis Dr. Wilhelm

Landeck, 6500, Austria

Location

Kepler Universitätsklinikum

Linz, 4021, Austria

Location

Praxis Dr. Dunst-Huemer

Linz, 4040, Austria

Location

Krankenanstalt Rudolfstiftung

Vienna, 1030, Austria

Location

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Praxis Dr. Göttfried

Vienna, 1100, Austria

Location

Praxis Dr. Holub-Hoberger

Vienna, 1100, Austria

Location

Krankenhaus Hietzing

Vienna, 1130, Austria

Location

Praxis Dr. Nordberg

Vienna, 1170, Austria

Location

Praxis Dr. Menzinger

Vienna, 1190, Austria

Location

Praxis Dr. Sator

Vienna, 1190, Austria

Location

Praxis Dr. Perl-Convalexius

Vienna, 1200, Austria

Location

Klinikum Wels-Grieskirchen GmbH

Wels, 4600, Austria

Location

Landesklinikum Wiener Neustadt

Wiener Neustadt, 2700, Austria

Location

Klinički bolnički centar Osijek Zavod za dermatologiju i venerologiju

Osijek, 31 000, Croatia

Location

Klinički bolnički centar Rijeka Klinika za dermatovenerologiju

Rijeka, 51000, Croatia

Location

Klinički bolnički centar Split Klinika za kožne i spolne bolesti

Split, 21 000, Croatia

Location

Klinički bolnički centar Sestre milosrdnice Klinika za kožne i spolne bolest

Zagreb, 10 000, Croatia

Location

Klinički bolnički centar Zagreb Klinika za dermatovenerologiju

Zagreb, 10 000, Croatia

Location

Fakultní nemocnice Hradec Králové Klinika nemocí kožních a pohlavních

Hradec Králové, Novy Hradec Králové, 500 05, Czechia

Location

Nemocnice Pardubického kraje

Pardubice, Pardubice IV, 530 03, Czechia

Location

Sanatorium profesora Arenberger

Prague, Praha 1, 110 00, Czechia

Location

Všeobecná fakultní nemocnice v Praze

Prague, Praha 2, 128 08, Czechia

Location

Fakultní nemocnice v Motole

Prague, Praha 5, 150 06, Czechia

Location

Nemocnice Jihlava příspěvková organizace

Jihlava, 586 33, Czechia

Location

FN Plzen Bory Dermatovenerologické oddělení

Pilsen, 301 00, Czechia

Location

Company for Medical Study & Service

Selters, Westerwald, 56242, Germany

Location

Praxis Dr. Harst

Aachen, 52062, Germany

Location

Praxis Dr. Wagner-Schiffler

Aachen, 52066, Germany

Location

Praxis Dr. Dietz

Ampfing, 84539, Germany

Location

Praxis Dr. Bell

Andernach, 56626, Germany

Location

Licca Clinical Research Institute

Augsburg, 86179, Germany

Location

Gefäß- und Hautzentrum Blaustein

Blaustein, 89134, Germany

Location

St. Josef und St. Elisabeth Hospital gGmbH

Bochum, 44791, Germany

Location

Rheinische Friedrich-Wilhelms-Universität Bonn

Bonn, 53127, Germany

Location

Praxis Dr. Jordan

Brühl, 50321, Germany

Location

Elbe Klinikum Buxtehude

Buxtehude, 21614, Germany

Location

Praxis Dr. Schneider

Dachau, 85221, Germany

Location

Praxis Dr. Thelen

Delmenhorst, 27753, Germany

Location

Klinikum Dortmund

Dortmund, 44137, Germany

Location

Praxis Dr. Scheibner

Dresden, 01217, Germany

Location

Praxis Dr. Korge

Düren, 52349, Germany

Location

Praxis für Dermatologie und Venerologie, Allergologie

Eltville, 65343, Germany

Location

Praxis Dr. Schurhammer-Fuhrmann

Endingen, 79346, Germany

Location

Uniklinikum Erlangen

Erlangen, 91054, Germany

Location

Praxis Dr. Huerkamp

Euskirchen, 53879, Germany

Location

Praxis Dr. Swirski

Euskirchen, 53879, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Praxis Dr. Kämmerer

Freiberg, 09599, Germany

Location

Praxis Dr. Kurzen

Freising, 85354, Germany

Location

GP Dr. Rotterdam & Kollegen

Gelsenkirchen, 45883, Germany

Location

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

Gilching, 82205, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Praxis Dr. Schmidt

Kusel, 66869, Germany

Location

Praxis Birgit Zimmermann

Malchow, 17231, Germany

Location

Praxis Dr. Piontek

Mechernich, 53894, Germany

Location

Dermatologische Praxis Dr. med. Schwinn

Memmingen, 87700, Germany

Location

Praxis Büchler

Memmingen, 87700, Germany

Location

Praxis Dr. Antal

Mühldorf, 84453, Germany

Location

Praxis Dr. Cords

Mühlheim, 56218, Germany

Location

Praxis Dr. Liebich

München, 80331, Germany

Location

Technische Universität München

München, 80802, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Praxis Dr. Prell

Rosenheim, 83022, Germany

Location

Praxis Dr. Blank

Rostock, 18055, Germany

Location

Praxis Dr. Hoene

Rostock, 18059, Germany

Location

Praxis Dr. Schenkelberger

Sankt Ingbert, 66386, Germany

Location

Praxis Dr. Neisius

Stolberg, 52222, Germany

Location

Praxis Dr. Steinborn

Straubing, 94315, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Gemeinschaftspraxis Dr. Christian Fischer, Florian Kreuziger

Vilshofen, 94474, Germany

Location

Praxis Dr. Dehmel

Wasserburg am Inn, 83512, Germany

Location

Praxis Dr. Schmeel

Wesseling, 50389, Germany

Location

Praxis Dr. Buttgereit

Wildau, 15745, Germany

Location

Praxis Dr. Süß

Wittlich, 54516, Germany

Location

Bon Secours Hospital

Tralee, County Kerry, Ireland

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

University Hospital Galway

Galway, H91 YR71, Ireland

Location

Uniiverzitetni klinični center Maribor Oddelek za kožne in spolne bolezni

Maribor, 2000, Slovenia

Location

Hospital Fundacion Alcorcon, Madrid

Alcorcón, Madrid, 28922, Spain

Location

Vithas Xanit Iinternational Hospital

Benalmádena, 29631, Spain

Location

Hospital Universitario San Cecilio (PTS)

Granada, 18016, Spain

Location

Hospital Virgen de la Victoria

Málaga, 29010, Spain

Location

Hudkliniken Mälarsjukhuset

Eskilstuna, 631 88, Sweden

Location

Hudkliniken SU/ Sahlgrenska

Gothenburg, 413 45, Sweden

Location

Hudmottagningen Karlskoga Lasarett

Karlskoga, 69181, Sweden

Location

Hudmottagningen Lindesbergs Lasarett

Lindesberg, 711 35, Sweden

Location

Capio Citykliniken Lund

Lund, 222 21, Sweden

Location

Diagnostiskt Centrum Hud Malmö

Malmo, 211 18, Sweden

Location

SUS Malmö Hudkliniken

Malmo, 214 28, Sweden

Location

Hudkliniken Vrinnevisjukhuset Norrköping

Norrköping, 601 82, Sweden

Location

Diagnostiskt Centrum Hud Stockholm

Stockholm, 111 37, Sweden

Location

Cutisgruppen/Stockholm Hud

Stockholm, 113 22, Sweden

Location

Hudkliniken SÖS

Stockholm, 118 83, Sweden

Location

Hudcentrum Hagastaden

Stockholm, 133 30, Sweden

Location

Karolinska Psoriasis Center

Stockholm, 17176, Sweden

Location

Hudkliniken Danderyds Sjukhus

Stockholm, 182 88, Sweden

Location

Hudmottagningen Trelleborg

Trelleborg, 231 85, Sweden

Location

Hudmottagningen Västervik

Västervik, 593 33, Sweden

Location

Dermatologie Aesche

Basel, 4051, Switzerland

Location

Somamedica

Basel, 4052, Switzerland

Location

Ospedale Bellinzona e Valli EOC

Bellinzona, 6500, Switzerland

Location

Insel Gruppe AG

Bern, 3010, Switzerland

Location

Clinique dermatologie du Seujet

Geneva, 1201, Switzerland

Location

Hautarzt Oberaargau AG

Herzogenbuchsee, 3360, Switzerland

Location

Centre hospitalier universitaire Vaudois (CHUV)

Lausanne, 1011, Switzerland

Location

Studio medico Dr. Pelloni

Lugano, 6900, Switzerland

Location

Practice Dr. Niklaus

Martigny-Ville, 1920, Switzerland

Location

Pallas Klinik Olten

Olten, 4600, Switzerland

Location

Haut und Laserzentrum Dr. Zuder

Sankt Gallen, 9000, Switzerland

Location

Praxis Dr. med. Christian Schuster

Sankt Gallen, 9000, Switzerland

Location

Haut und Allergiezentrum Brunnehof

Uster, 8610, Switzerland

Location

Dr. Tomi Haut- und Laserzentrum

Weinfelden, 8570, Switzerland

Location

Hautpraxis Dermateam

Winterthur, 8400, Switzerland

Location

Praxisgemeinschaft Bünz AG

Wohlen, 5610, Switzerland

Location

Zug Hautarzt

Zug, 6300, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZB, United Kingdom

Location

Bradford Teaching Hospitals NHS

Bradford, BD9 6RJ, United Kingdom

Location

West Suffolk NHS Foundation

Bury St Edmunds, IP33 2QZ, United Kingdom

Location

East Kent & Canterbury Hospital

Canterbury, CT1 3NG, United Kingdom

Location

NHS Dumfries and Galloway

Dumfries, DG1 4AP, United Kingdom

Location

Royal Devon & Exeter NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

West Middlesex University Hospital

Isleworth, TW7 6AF, United Kingdom

Location

Chapel Allerton Hospital

Leeds, LS9 7TF, United Kingdom

Location

Guy's and St Thomas's NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Chelsea & Westminster NHS Foundation Trust

London, SW10 9NH, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

University of Manchester

Salford, M6 8HD, United Kingdom

Location

Warwick Hospital

Warwick, CV34 5BW, United Kingdom

Location

Related Publications (4)

  • 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.

    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.

    PMID: 36862361BACKGROUND
  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Psoriasis

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 15, 2016

Study Start

June 30, 2016

Primary Completion

October 27, 2021

Study Completion

October 27, 2021

Last Updated

March 4, 2024

Record last verified: 2024-03

Locations