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PsoriasisAPPRECIATENCT02740218

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

An observational study of Psoriasis, run by Amgen at 133 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Patient questionnaire
How many people
610 participants
Where
133 sitesin 10 countries
Study dates
30 Jun 2016to 27 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

133 sites in 10 countries.

133 sites in 10 countries

Germany49 sites

  • Praxis Dr. Harst

    Aachen, 52062

  • Praxis Dr. Wagner-Schiffler

    Aachen, 52066

  • Praxis Dr. Dietz

    Ampfing, 84539

  • Praxis Dr. Bell

    Andernach, 56626

  • Licca Clinical Research Institute

    Augsburg, 86179

  • Gefäß- und Hautzentrum Blaustein

    Blaustein, 89134

  • St. Josef und St. Elisabeth Hospital gGmbH

    Bochum, 44791

  • Rheinische Friedrich-Wilhelms-Universität Bonn

    Bonn, 53127

  • Praxis Dr. Jordan

    Brühl, 50321

  • Elbe Klinikum Buxtehude

    Buxtehude, 21614

  • Praxis Dr. Schneider

    Dachau, 85221

  • Praxis Dr. Thelen

    Delmenhorst, 27753

  • Klinikum Dortmund

    Dortmund, 44137

  • Praxis Dr. Scheibner

    Dresden, 01217

  • Praxis Dr. Korge

    Düren, 52349

  • Praxis für Dermatologie und Venerologie, Allergologie

    Eltville, 65343

  • Praxis Dr. Schurhammer-Fuhrmann

    Endingen, 79346

  • Uniklinikum Erlangen

    Erlangen, 91054

  • Praxis Dr. Huerkamp

    Euskirchen, 53879

  • Praxis Dr. Swirski

    Euskirchen, 53879

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

  • Praxis Dr. Kämmerer

    Freiberg, 09599

  • Praxis Dr. Kurzen

    Freising, 85354

  • GP Dr. Rotterdam & Kollegen

    Gelsenkirchen, 45883

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

    Gilching, 82205

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Praxis Dr. Schmidt

    Kusel, 66869

  • Praxis Birgit Zimmermann

    Malchow, 17231

  • Praxis Dr. Piontek

    Mechernich, 53894

  • Dermatologische Praxis Dr. med. Schwinn

    Memmingen, 87700

  • Praxis Büchler

    Memmingen, 87700

  • Praxis Dr. Antal

    Mühldorf, 84453

  • Praxis Dr. Cords

    Mühlheim, 56218

  • Praxis Dr. Liebich

    München, 80331

  • Technische Universität München

    München, 80802

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Praxis Dr. Prell

    Rosenheim, 83022

  • Praxis Dr. Blank

    Rostock, 18055

  • Praxis Dr. Hoene

    Rostock, 18059

  • Praxis Dr. Schenkelberger

    Sankt Ingbert, 66386

  • Company for Medical Study & Service

    Selters, Westerwald, 56242

  • Praxis Dr. Neisius

    Stolberg, 52222

  • Praxis Dr. Steinborn

    Straubing, 94315

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Gemeinschaftspraxis Dr. Christian Fischer, Florian Kreuziger

    Vilshofen, 94474

  • Praxis Dr. Dehmel

    Wasserburg am Inn, 83512

  • Praxis Dr. Schmeel

    Wesseling, 50389

  • Praxis Dr. Buttgereit

    Wildau, 15745

  • Praxis Dr. Süß

    Wittlich, 54516

Other trials in Germany

Switzerland18 sites

  • Dermatologie Aesche

    Basel, 4051

  • Somamedica

    Basel, 4052

  • Ospedale Bellinzona e Valli EOC

    Bellinzona, 6500

  • Insel Gruppe AG

    Bern, 3010

  • Clinique dermatologie du Seujet

    Geneva, 1201

  • Hautarzt Oberaargau AG

    Herzogenbuchsee, 3360

  • Centre hospitalier universitaire Vaudois (CHUV)

    Lausanne, 1011

  • Studio medico Dr. Pelloni

    Lugano, 6900

  • Practice Dr. Niklaus

    Martigny-Ville, 1920

  • Pallas Klinik Olten

    Olten, 4600

  • Haut und Laserzentrum Dr. Zuder

    Sankt Gallen, 9000

  • Praxis Dr. med. Christian Schuster

    Sankt Gallen, 9000

  • Haut und Allergiezentrum Brunnehof

    Uster, 8610

  • Dr. Tomi Haut- und Laserzentrum

    Weinfelden, 8570

  • Hautpraxis Dermateam

    Winterthur, 8400

  • Praxisgemeinschaft Bünz AG

    Wohlen, 5610

  • Zug Hautarzt

    Zug, 6300

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Austria17 sites

  • Medizinische Universität Graz

    Graz, 8036

  • Praxis Dr. Wolfgang Fuchs

    Grosswarasdorf, 7304

  • Praxis Dr. Schicher

    Klagenfurt, 9020

  • Praxis Dr. Wilhelm

    Landeck, 6500

  • Kepler Universitätsklinikum

    Linz, 4021

  • Praxis Dr. Dunst-Huemer

    Linz, 4040

  • Krankenanstalt Rudolfstiftung

    Vienna, 1030

  • Medizinische Universität Wien

    Vienna, 1090

  • Praxis Dr. Göttfried

    Vienna, 1100

  • Praxis Dr. Holub-Hoberger

    Vienna, 1100

  • Krankenhaus Hietzing

    Vienna, 1130

  • Praxis Dr. Nordberg

    Vienna, 1170

  • Praxis Dr. Menzinger

    Vienna, 1190

  • Praxis Dr. Sator

    Vienna, 1190

  • Praxis Dr. Perl-Convalexius

    Vienna, 1200

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, 2700

Other trials in Austria

Sweden16 sites

  • Hudkliniken Mälarsjukhuset

    Eskilstuna, 631 88

  • Hudkliniken SU/ Sahlgrenska

    Gothenburg, 413 45

  • Hudmottagningen Karlskoga Lasarett

    Karlskoga, 69181

  • Hudmottagningen Lindesbergs Lasarett

    Lindesberg, 711 35

  • Capio Citykliniken Lund

    Lund, 222 21

  • Diagnostiskt Centrum Hud Malmö

    Malmö, 211 18

  • SUS Malmö Hudkliniken

    Malmö, 214 28

  • Hudkliniken Vrinnevisjukhuset Norrköping

    Norrköping, 601 82

  • Diagnostiskt Centrum Hud Stockholm

    Stockholm, 111 37

  • Cutisgruppen/Stockholm Hud

    Stockholm, 113 22

  • Hudkliniken SÖS

    Stockholm, 118 83

  • Hudcentrum Hagastaden

    Stockholm, 133 30

  • Karolinska Psoriasis Center

    Stockholm, 17176

  • Hudkliniken Danderyds Sjukhus

    Stockholm, 182 88

  • Hudmottagningen Trelleborg

    Trelleborg, 231 85

  • Hudmottagningen Västervik

    Västervik, 593 33

Other trials in Sweden

United Kingdom13 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZB

  • Bradford Teaching Hospitals NHS

    Bradford, BD9 6RJ

  • West Suffolk NHS Foundation

    Bury St Edmunds, IP33 2QZ

  • East Kent & Canterbury Hospital

    Canterbury, CT1 3NG

  • NHS Dumfries and Galloway

    Dumfries, DG1 4AP

  • Royal Devon & Exeter NHS Foundation Trust

    Exeter, EX2 5DW

  • West Middlesex University Hospital

    Isleworth, TW7 6AF

  • Chapel Allerton Hospital

    Leeds, LS9 7TF

  • Guy's and St Thomas's NHS Foundation Trust

    London, SE1 9RT

  • Chelsea & Westminster NHS Foundation Trust

    London, SW10 9NH

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE7 7DN

  • University of Manchester

    Salford, M6 8HD

  • Warwick Hospital

    Warwick, CV34 5BW

Other trials in United Kingdom

Czechia7 sites

  • Fakultní nemocnice Hradec Králové Klinika nemocí kožních a pohlavních

    Hradec Králové, Novy Hradec Králové, 500 05

  • Nemocnice Jihlava příspěvková organizace

    Jihlava, 586 33

  • Nemocnice Pardubického kraje

    Pardubice, Pardubice IV, 530 03

  • FN Plzen Bory Dermatovenerologické oddělení

    Pilsen, 301 00

  • Sanatorium profesora Arenberger

    Prague, Praha 1, 110 00

  • Všeobecná fakultní nemocnice v Praze

    Prague, Praha 2, 128 08

  • Fakultní nemocnice v Motole

    Prague, Praha 5, 150 06

Other trials in Czechia

Croatia5 sites

  • Klinički bolnički centar Osijek Zavod za dermatologiju i venerologiju

    Osijek, 31 000

  • Klinički bolnički centar Rijeka Klinika za dermatovenerologiju

    Rijeka, 51000

  • Klinički bolnički centar Split Klinika za kožne i spolne bolesti

    Split, 21 000

  • Klinički bolnički centar Sestre milosrdnice Klinika za kožne i spolne bolest

    Zagreb, 10 000

  • Klinički bolnički centar Zagreb Klinika za dermatovenerologiju

    Zagreb, 10 000

Other trials in Croatia

Spain4 sites

  • Hospital Fundacion Alcorcon, Madrid

    Alcorcón, Madrid, 28922

  • Vithas Xanit Iinternational Hospital

    Benalmádena, 29631

  • Hospital Universitario San Cecilio (PTS)

    Granada, 18016

  • Hospital Virgen de la Victoria

    Málaga, 29010

Other trials in Spain

Ireland3 sites

  • Mater Misericordiae University Hospital

    Dublin

  • University Hospital Galway

    Galway, H91 YR71

  • Bon Secours Hospital

    Tralee, County Kerry

Other trials in Ireland

Slovenia1 site

  • Uniiverzitetni klinični center Maribor Oddelek za kožne in spolne bolezni

    Maribor, 2000

Other trials in Slovenia

About this study

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

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.

Conditions
Psoriasis
Being tested
Patient questionnaire
Keywords
Psoriasis, Apremilast, APPRECIATE, Dermatology, Retrospective, Observational
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient questionnaireOther

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

Study groups in NCT02740218
Study groupRoleWhat they receive
Psoriasis patientsSingle cohort of psoriasis patients treated with OTEZLA (apremilast)
Receives: Other: Patient questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 7 months

Secondary outcomes (10)

  1. Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score

    The TSQM-9 is a self-administrated instrument to understand a subject's satisfaction on the current therapy

    Measured: Up to approximately 7 months

  2. Percentage of patients achieving PASI75

    PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.

    Measured: Up to approximately 7 months

  3. Percentages of patients achieving PASI50

    PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.

    Measured: Up to approximately 7 months

  4. Mean change in Dermatology Life Quality Index (DLQI)

    DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.

    Measured: Up to approximately 7 months

  5. Percentages of patients achieving ≥5 point improvement in DLQI

    DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.

    Measured: Up to approximately 7 months

  6. Percentages of patients achieving PASI50 plus ≥5 point improvement in DLQI

    PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.

    DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease

    Measured: Up to approximately 7 months

  7. Mean change in Body Surface Area (BSA)

    BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area.

    Measured: Up to approximately 7 months

  8. Mean change in PGA

    The PGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the assessor factors in areas that have already cleared (ie, have scores of 0) and not just remaining lesions for severity, ie, the severity of each sign was to be averaged across all areas of involvement, including cleared lesions

    Measured: Up to approximately 7 months

  9. Percentage of patients achieving PGA 0/1 (clear/almost clear)

    The PGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the assessor factors in areas that have already cleared (ie, have scores of 0) and not just remaining lesions for severity, ie, the severity of each sign was to be averaged across all areas of involvement, including cleared lesions

    Measured: Up to approximately 7 months

  10. Adverse Events (AEs)

    Number of patients with adverse events

    Measured: Up to approximately 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2016 (estimated)
  2. Study start30 Jun 2016
  3. Primary completion27 Oct 2021
  4. Study completion27 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
610 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02740218
Sponsor's protocol ID
CC-10004-PSOR-013
Acronym
APPRECIATE
Status last verified
Mar 2024
First submitted
12 Apr 2016
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
No

Publications

  • 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.

  • 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.

    PubMed 36862361

  • 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.

    PubMed 39969771

  • 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.

    PubMed 36777399

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis, run by Amgen at 133 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in Germany, Switzerland, Austria, Sweden, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Patient Benefit Index (PBI) outcome score (time frame: Up to approximately 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02740218, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.

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