Clinical trial NCT02626793: A Study of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions
Official title: Long-term Documentation of the Utilization of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions (LAPIS-Pso)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Plaque psoriasis
Apremilast
Otezla®
LAPIS-Pso
Observational
CC-10004
non-interventional
Germany
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-12-10
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 500 patients with moderate to severe plaque psoriasis are planned to be enrolled in this NIS. In- and exclusion criteria are derived from the Summary of product characteristics (SmPC) of Apremilast.

Brief summary: The objective of this NIS is the collection of data on the utilization of Apremilast under routine conditions in Germany. Patients' quality-of-life and treatment satisfaction on treatment with Apremilast in daily practice will be documented. Moreover, physician's and patient's assessments of the effectiveness and safety of Apremilast will be recorded. FPI was 3rd August 2015, LPO was 14th of June 2018. A total of 391 patients have been enrolled.

Detailed description: The objective of this NIS (according to section 4(23) of the German Medicinal Products Act) is the documentation of data on the effectiveness and tolerability of an Apremilast treatment under routine clinical conditions in German patients with plaque psoriasis.

This NIS is intended to reflect the apremilast treatment of patients with plaque psoriasis who have received at least one prior conventional, systemic therapy or, if a contraindication is present, did not receive a systemic therapy so far, and who were diagnosed by their treating physicians to be eligible for an apremilast treatment. The treatment of Apremilast will be documented for a period of approximately 52 weeks.

Eligibility criteria: Inclusion Criteria:

* The decision for a therapy with Apremilast was made before enrolment and independent of this study.
* Patient ≥ 18 years of age
* Diagnosis of moderate to severe plaque psoriasis
* Inadequate response or intolerance to a previous systemic treatment, or contraindication for systemic therapies.
* Written informed consent by the patient for data recording, statistical analysis, filing and forwarding of the data

Exclusion Criteria:

* Pregnancy
* Hypersensitivity to apremilast or any of the excipients of the film-coated tablet
* Other criteria according to the Summary of product characteristics (SmPC).

Primary outcomes:
measure: Change from baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at Visit 2 from baseline
timeFrame: Approximately 4 months
Secondary outcomes:
measure: Change from Baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at all other visits from baseline.
timeFrame: Up to approximately 52 weeks
measure: Change in the Physician Global Assessment (PGA) Score
timeFrame: Up to approximately 52 weeks
measure: Percent Change in Percent of Affected Body Surface Area (BSA)
timeFrame: Up to approximately 52 weeks
measure: Percent Change in the Psoriasis Area Severity Index (PASI) Score
timeFrame: Up to approximately 52 weeks
measure: Change in the Patient's Global Assessment (PaGA)
timeFrame: Up to approximately 52 weeks
measure: Patient Preference Questionnaire (PPQ)
timeFrame: Approximately 4 months
measure: Patient Satisfaction (Systemic Therapy Adherence Questionnaire, STAQ)
timeFrame: Approximately 13 months
measure: Change in Pain (Visual Analogue Scale; VAS)
timeFrame: Up to approximately 52 weeks
measure: Adverse Events (AEs)
timeFrame: Up to approximately 52 weeks
measure: Change in Itch (Pruritus) (Visual Analogue Scale; VAS)
timeFrame: Up to approximately 52 weeks
measure: Change in Scalp Involvement -Physician's Global Assessment (PGA)
timeFrame: Up to approximately 52 weeks
measure: Change in Scalp Involvement - Patient's Global Assessment (PaGA)
timeFrame: Up to approximately 52 weeks
measure: Change in Nail Involvement - Target Nail Psoriasis Severity Index (NAPSI)
timeFrame: Up to approximately 52 weeks
measure: Change in Nail Involvement Fingernail - Patient's Global Assessment (PaGA)
timeFrame: Up to approximately 52 weeks
measure: Change in Palmoplantar involvement - Palmoplantar physician's global assessment (PGA)
timeFrame: Up to approximately 52 weeks
measure: Change in Palmoplantar involvement - Palmoplantar patient's global assessment (PaGA)
timeFrame: Up to approximately 52 weeks
Other outcomes:
Locations:
city: Blaubeuren
country: Germany
facility: Gertraud Krähn-Senftleben
state: Baden-Württemberg
city: Blaustein
country: Germany
facility: Ralf-Uwe Peter
state: Baden-Württemberg
city: Esslingen am Neckar
country: Germany
facility: Regina Renner
state: Baden-Württemberg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg - Hautklinik
state: Baden-Württemberg
city: Karlsruhe
country: Germany
facility: Ina Reitenbach-Blindt
state: Baden-Württemberg
city: Karlsruhe
country: Germany
facility: Kaiserstraße 231-233
state: Baden-Württemberg
city: Karlsruhe
country: Germany
facility: Naomi Gerhardus
state: Baden-Württemberg
city: Karlsruhe
country: Germany
facility: Johannes Glutsch
state: Baden-Württemberg
city: Langenau
country: Germany
facility: Beate Schwarz
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Astrid Schmieder
state: Baden-Württemberg
city: Spaichingen
country: Germany
facility: Katharina Wroblewska
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: Michael Sticherling
state: Bayern
city: Freising
country: Germany
facility: Hjalmar Kurzen
state: Bayern
city: Germering
country: Germany
facility: Claus Jung
state: Bayern
city: Hersbruck
country: Germany
facility: Clarissa Allmacher
state: Bayern
city: Krumbach
country: Germany
facility: Ildiko Sugar-Bunk
state: Bayern
city: München
country: Germany
facility: Sabine Anders
state: Bayern
city: München
country: Germany
facility: Hortensia Pfannenstiel
state: Bayern
city: München
country: Germany
facility: Technische Universität München - Kilian Eyerich
state: Bayern
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
state: Bayern
city: Würzburg
country: Germany
facility: Andreas Eggert
state: Bayern
city: Falkensee
country: Germany
facility: Lars Freitag
state: Brandenburg
city: Kleinmachnow
country: Germany
facility: Förster-Funke-Allee 104
state: Brandenburg
city: Schwedt
country: Germany
facility: Silke Thies
state: Brandenburg
city: Eltville
country: Germany
facility: Christoph Hartl
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
state: Hessen
city: Schwalmstadt
country: Germany
facility: Pia Freyschmidt-Paul
state: Hessen
city: Bergen
country: Germany
facility: Andreas Timmel
state: Mecklenburg-Vorpommern
city: Neubrandenburg
country: Germany
facility: Raimund Paech
state: Mecklenburg-Vorpommern
city: Braunschweig
country: Germany
facility: Jutta Ramaker-Brunke
state: Niedersachsen
city: Buxtehude
country: Germany
facility: Andreas Kleinheinz
state: Niedersachsen
city: Cloppenburg
country: Germany
facility: Marco Averbeck
state: Niedersachsen
city: Hannover
country: Germany
facility: Florian Schenck
state: Niedersachsen
city: Hannover
country: Germany
facility: Ulrike Stein
state: Niedersachsen
city: Hildesheim
country: Germany
facility: Holger Petering
state: Niedersachsen
city: Holzminden
country: Germany
facility: Silke Reinecke
state: Niedersachsen
city: Lüneburg
country: Germany
facility: Reinhard Knöll
state: Niedersachsen
city: Vechta
country: Germany
facility: Christian Kock
state: Niedersachsen
city: Winsen
country: Germany
facility: Gesundheitszentrum Winsen
state: Niedersachsen
city: Aachen
country: Germany
facility: Theaterplatz 9
state: Nordrhein-Westfalen
city: Bielefeld
country: Germany
facility: Isaak Effendy
state: Nordrhein-Westfalen
city: Duisburg
country: Germany
facility: Volker Riesopp
state: Nordrhein-Westfalen
city: Düren
country: Germany
facility: Bernhard Korge
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
facility: Herderstr.71 b
state: Nordrhein-Westfalen
city: Eschweiler
country: Germany
facility: Dechant-Deckers-Straße 5-7
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Euskirchen
country: Germany
facility: Christina Huerkamp
state: Nordrhein-Westfalen
city: Gelsenkirchen-Feldmark
country: Germany
facility: Sebastian Rotterdam
state: Nordrhein-Westfalen
city: Gladbeck
country: Germany
facility: Jörg Brinkmann
state: Nordrhein-Westfalen
city: Kleve
country: Germany
facility: Hautartzpraxis
state: Nordrhein-Westfalen
city: Minden
country: Germany
facility: Rudolf Stadler
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
facility: Rolf Ostendorf
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Athanasios Tsianakas
state: Nordrhein-Westfalen
city: Rheinbach
country: Germany
facility: Stefanie Montag
state: Nordrhein-Westfalen
city: Stolberg (Rheinland)
country: Germany
facility: Hautarztpraxis, Steinfeldstr. 5
state: Nordrhein-Westfalen
city: Velbert
country: Germany
facility: Oliver Mainusch
state: Nordrhein-Westfalen
city: Wesel
country: Germany
facility: Kurt-Kräcker-Str. 47
state: Nordrhein-Westfalen
city: Bendorf
country: Germany
facility: Ulrich Blaese
state: Rheinland Pfalz
city: Andernach
country: Germany
facility: Magnus Bell
state: Rheinland-Pfalz
city: Koblenz
country: Germany
facility: Schloss Straße 17
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: Petra Staubach-Renz
state: Rheinland-Pfalz
city: Maxdorf
country: Germany
facility: Dirk Maaßen
state: Rheinland-Pfalz
city: Neuwied
country: Germany
facility: Marktstr. 20
state: Rheinland-Pfalz
city: Prüm
country: Germany
facility: Praxis für Haut- und Geschlechtskrankheiten - Allergologie - Am Johannisborn
state: Rheinland-Pfalz
city: Selters
country: Germany
facility: Ralph von Kiedrowski
state: Rheinland-Pfalz
city: Simmern
country: Germany
facility: Mohammad Asefi
state: Rheinland-Pfalz
city: Eilenburg
country: Germany
facility: Puschkinstr. 110
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Franckestr. 1
state: Sachsen-Anhalt
city: Quedlinburg
country: Germany
facility: Jens Ulrich
state: Sachsen-Anhalt
city: Weißenfels
country: Germany
facility: Gabriela Fiedler
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Karolin Schneider
state: Sachsen
city: Dresden
country: Germany
facility: Beatrice Gerlach
state: Sachsen
city: Dresden
country: Germany
facility: Liane John
state: Sachsen
city: Dresden
country: Germany
facility: Mary-Krebs-Straße 1
state: Sachsen
city: Dresden
country: Germany
facility: Stefan Beissert
state: Sachsen
city: Leipzig
country: Germany
facility: Bernhard-Göring-Str. 162
state: Sachsen
city: Leipzig
country: Germany
facility: Riebeckstraße 65
state: Sachsen
city: Wurzen
country: Germany
facility: Schweizergartenstr. 2a
state: Sachsen
city: Kiel
country: Germany
facility: Harald Brüning
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Neumünster
country: Germany
facility: Christian Meewes
state: Schleswig-Holstein
city: Artern
country: Germany
facility: Jens Thieme
state: Thüringen
city: Heiligenstadt
country: Germany
facility: Mario Pawlak
state: Thüringen
city: Berlin
country: Germany
facility: Raoul Hasert
city: Berlin
country: Germany
facility: Klaus Spickermann
city: Berlin
country: Germany
facility: Jens Olaf Mielcke
city: Berlin
country: Germany
facility: Albert-Einstein-Str. 2
city: Berlin
country: Germany
facility: Hautarztpraxis Zahn
city: Berlin
country: Germany
facility: Maria Manasterski
city: Berlin
country: Germany
facility: Martin Miehe
city: Bremen
country: Germany
facility: Uwe Schwichtenberg
city: Hamburg
country: Germany
facility: Matthias Augustin
city: Hamburg
country: Germany
facility: Kristian Reich
city: Hamburg
country: Germany
facility: Christian Mensing
city: Königs Wusterhausen
country: Germany
facility: Johannes-R.-Becher-Straße 24
city: Vilshofen
country: Germany
facility: Florian Kreuziger
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Reich K, Korge B, Magnolo N, Manasterski M, Schwichtenberg U, Staubach-Renz P, Kaiser S, Roemmler-Zehrer J, Gomez NN, Lorenz-Baath K. Quality-of-Life Outcomes, Effectiveness and Tolerability of Apremilast in Patients with Plaque Psoriasis and Routine German Dermatology Care: Results from LAPIS-PSO. Dermatol Ther (Heidelb). 2022 Jan;12(1):203-221. doi: 10.1007/s13555-021-00658-x. Epub 2021 Dec 15.