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

Psoriasis Clinical Trial

— APPRECIATE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02740218
• Other study ID #: CC-10004-PSOR-013
• Status: Completed
• Start date: June 30, 2016
• Est. completion date: October 27, 2021

Study information

• Verified date: March 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
Austria	Praxis Dr. Wolfgang Fuchs	Großwarasdorf
Austria	Praxis Dr. Schicher	Klagenfurt
Austria	Praxis Dr. Wilhelm	Landeck
Austria	Kepler Universitätsklinikum	Linz
Austria	Praxis Dr. Dunst-Huemer	Linz
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Austria	Krankenanstalt Rudolfstiftung	Wien
Austria	Krankenhaus Hietzing	Wien
Austria	Medizinische Universität Wien	Wien
Austria	Praxis Dr. Göttfried	Wien
Austria	Praxis Dr. Holub-Hoberger	Wien
Austria	Praxis Dr. Menzinger	Wien
Austria	Praxis Dr. Nordberg	Wien
Austria	Praxis Dr. Perl-Convalexius	Wien
Austria	Praxis Dr. Sator	Wien
Austria	Landesklinikum Wiener Neustadt	Wiener Neustadt
Croatia	Klinicki bolnicki centar Osijek Zavod za dermatologiju i venerologiju	Osijek
Croatia	Klinicki bolnicki centar Rijeka Klinika za dermatovenerologiju	Rijeka
Croatia	Klinicki bolnicki centar Split Klinika za kožne i spolne bolesti	Split
Croatia	Klinicki bolnicki centar Sestre milosrdnice Klinika za kožne i spolne bolest	Zagreb
Croatia	Klinicki bolnicki centar Zagreb Klinika za dermatovenerologiju	Zagreb
Czechia	Fakultní nemocnice Hradec Králové Klinika nemocí kožních a pohlavních	Hradec Králové	Novy Hradec Králové
Czechia	Nemocnice Jihlava príspevková organizace	Jihlava
Czechia	Nemocnice Pardubického kraje	Pardubice	Pardubice IV
Czechia	FN Plzen Bory Dermatovenerologické oddelení	Plzen
Czechia	Fakultní nemocnice v Motole	Praha	Praha 5
Czechia	Sanatorium profesora Arenberger	Praha	Praha 1
Czechia	Všeobecná fakultní nemocnice v Praze	Praha	Praha 2
Germany	Praxis Dr. Harst	Aachen
Germany	Praxis Dr. Wagner-Schiffler	Aachen
Germany	Praxis Dr. Dietz	Ampfing
Germany	Praxis Dr. Bell	Andernach
Germany	Licca Clinical Research Institute	Augsburg
Germany	Gefäß- und Hautzentrum Blaustein	Blaustein
Germany	St. Josef und St. Elisabeth Hospital gGmbH	Bochum
Germany	Rheinische Friedrich-Wilhelms-Universität Bonn	Bonn
Germany	Praxis Dr. Jordan	Brühl
Germany	Elbe Klinikum Buxtehude	Buxtehude
Germany	Praxis Dr. Schneider	Dachau
Germany	Praxis Dr. Thelen	Delmenhorst
Germany	Klinikum Dortmund	Dortmund
Germany	Praxis Dr. Scheibner	Dresden
Germany	Praxis Dr. Korge	Düren
Germany	Praxis für Dermatologie und Venerologie, Allergologie	Eltville
Germany	Praxis Dr. Schurhammer-Fuhrmann	Endingen
Germany	Uniklinikum Erlangen	Erlangen
Germany	Praxis Dr. Huerkamp	Euskirchen
Germany	Praxis Dr. Swirski	Euskirchen
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	Praxis Dr. Kämmerer	Freiberg
Germany	Praxis Dr. Kurzen	Freising
Germany	GP Dr. Rotterdam & Kollegen	Gelsenkirchen
Germany	Praxis Dr. med W. Klövekorn, Dr. med. A. Tepe, Dr. med. O. Wilde	Gilching
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Praxis Dr. Schmidt	Kusel
Germany	Praxis Birgit Zimmermann	Malchow
Germany	Praxis Dr. Piontek	Mechernich
Germany	Dermatologische Praxis Dr. med. Schwinn	Memmingen
Germany	Praxis Büchler	Memmingen
Germany	Praxis Dr. Antal	Mühldorf
Germany	Praxis Dr. Cords	Mühlheim
Germany	Praxis Dr. Liebich	München
Germany	Technische Universität München	München
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Praxis Dr. Prell	Rosenheim
Germany	Praxis Dr. Blank	Rostock
Germany	Praxis Dr. Hoene	Rostock
Germany	Praxis Dr. Schenkelberger	Sankt Ingbert
Germany	Company for Medical Study & Service	Selters	Westerwald
Germany	Praxis Dr. Neisius	Stolberg
Germany	Praxis Dr. Steinborn	Straubing
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Gemeinschaftspraxis Dr. Christian Fischer, Florian Kreuziger	Vilshofen
Germany	Praxis Dr. Dehmel	Wasserburg am Inn
Germany	Praxis Dr. Schmeel	Wesseling
Germany	Praxis Dr. Buttgereit	Wildau
Germany	Praxis Dr. Süß	Wittlich
Ireland	Mater Misericordiae University Hospital	Dublin 7
Ireland	University Hospital Galway	Galway
Ireland	Bon Secours Hospital	Tralee	County Kerry
Slovenia	Uniiverzitetni klinicni center Maribor Oddelek za kožne in spolne bolezni	Maribor
Spain	Hospital Fundacion Alcorcon, Madrid	Alcorcón	Madrid
Spain	Vithas Xanit Iinternational Hospital	Benalmádena
Spain	Hospital Universitario San Cecilio (PTS)	Granada
Spain	Hospital Virgen de la Victoria	Malaga
Sweden	Hudkliniken Mälarsjukhuset	Eskilstuna
Sweden	Hudkliniken SU/ Sahlgrenska	Göteborg
Sweden	Hudmottagningen Karlskoga Lasarett	Karlskoga
Sweden	Hudmottagningen Lindesbergs Lasarett	Lindesberg
Sweden	Capio Citykliniken Lund	Lund
Sweden	Diagnostiskt Centrum Hud Malmö	Malmö
Sweden	SUS Malmö Hudkliniken	Malmö
Sweden	Hudkliniken Vrinnevisjukhuset Norrköping	Norrköping
Sweden	Cutisgruppen/Stockholm Hud	Stockholm
Sweden	Diagnostiskt Centrum Hud Stockholm	Stockholm
Sweden	Hudcentrum Hagastaden	Stockholm
Sweden	Hudkliniken Danderyds Sjukhus	Stockholm
Sweden	Hudkliniken SÖS	Stockholm
Sweden	Karolinska Psoriasis Center	Stockholm
Sweden	Hudmottagningen Trelleborg	Trelleborg
Sweden	Hudmottagningen Västervik	Västervik
Switzerland	Dermatologie Aesche	Basel
Switzerland	Somamedica	Basel
Switzerland	Ospedale Bellinzona e Valli EOC	Bellinzona
Switzerland	Insel Gruppe AG	Bern
Switzerland	Clinique dermatologie du Seujet	Genève
Switzerland	Hautarzt Oberaargau AG	Herzogenbuchsee
Switzerland	Centre hospitalier universitaire Vaudois (CHUV)	Lausanne
Switzerland	Studio medico Dr. Pelloni	Lugano
Switzerland	Practice Dr. Niklaus	Martigny
Switzerland	Pallas Klinik Olten	Olten
Switzerland	Haut und Laserzentrum Dr. Zuder	St. Gallen
Switzerland	Praxis Dr. med. Christian Schuster	St. Gallen
Switzerland	Haut und Allergiezentrum Brunnehof	Uster
Switzerland	Dr. Tomi Haut- und Laserzentrum	Weinfelden
Switzerland	Hautpraxis Dermateam	Winterthur
Switzerland	Praxisgemeinschaft Bünz AG	Wohlen
Switzerland	Zug Hautarzt	Zug
Switzerland	Universitätsspital Zürich	Zürich
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Bradford Teaching Hospitals NHS	Bradford
United Kingdom	West Suffolk NHS Foundation	Bury St Edmunds
United Kingdom	East Kent & Canterbury Hospital	Canterbury
United Kingdom	NHS Dumfries and Galloway	Dumfries
United Kingdom	Royal Devon & Exeter NHS Foundation Trust	Exeter
United Kingdom	West Middlesex University Hospital	Isleworth
United Kingdom	Chapel Allerton Hospital	Leeds
United Kingdom	Chelsea & Westminster NHS Foundation Trust	London
United Kingdom	Guy's and St Thomas's NHS Foundation Trust	London
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	University of Manchester	Salford
United Kingdom	Warwick Hospital	Warwick

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Austria,  Croatia,  Czechia,  Germany,  Ireland,  Slovenia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (2)

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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Up to approximately 7 months
Secondary	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.	Up to approximately 7 months
Secondary	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.	Up to approximately 7 months
Secondary	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.	Up to approximately 7 months
Secondary	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.	Up to approximately 7 months
Secondary	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	Up to approximately 7 months
Secondary	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.	Up to approximately 7 months
Secondary	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	Up to approximately 7 months
Secondary	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	Up to approximately 7 months
Secondary	Adverse Events (AEs)	Number of patients with adverse events	Up to approximately 7 months

External Links

•   AmgenTrials clinical trials website
•   Expanded Access for CC-10004