A Study of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions

NCT ID: NCT02626793

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 391 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-03
• Study Completion Date: 2018-06-14

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.

Conditions

Psoriasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with ≤ 1 conventional, systemic pre-treatment

After failure (inadequate response/intolerance) to or contraindication for ≤ 1 conventional, systemic pre-treatment

No interventions assigned to this group

Patients with > 1 conventional, systemic pre-treatment

After failure (inadequate response/intolerance) to or contraindication for \> 1 conventional, systemic pre-treatment

No interventions assigned to this group

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Gertraud Krähn-Senftleben

Blaubeuren Abbey, Baden-Wurttemberg, Germany

Ralf-Uwe Peter

Blaustein, Baden-Wurttemberg, Germany

Regina Renner

Esslingen am Neckar, Baden-Wurttemberg, Germany

Universitätsklinikum Heidelberg - Hautklinik

Heidelberg, Baden-Wurttemberg, Germany

Ina Reitenbach-Blindt

Karlsruhe, Baden-Wurttemberg, Germany

Kaiserstraße 231-233

Karlsruhe, Baden-Wurttemberg, Germany

Naomi Gerhardus

Karlsruhe, Baden-Wurttemberg, Germany

Johannes Glutsch

Karlsruhe, Baden-Wurttemberg, Germany

Beate Schwarz

Langenau, Baden-Wurttemberg, Germany

Astrid Schmieder

Mannheim, Baden-Wurttemberg, Germany

Katharina Wroblewska

Spaichingen, Baden-Wurttemberg, Germany

Michael Sticherling

Erlangen, Bavaria, Germany

Hjalmar Kurzen

Freising, Bavaria, Germany

Claus Jung

Germering, Bavaria, Germany

Clarissa Allmacher

Hersbruck, Bavaria, Germany

Ildiko Sugar-Bunk

Krumbach, Bavaria, Germany

Sabine Anders

München, Bavaria, Germany

Hortensia Pfannenstiel

München, Bavaria, Germany

Technische Universität München - Kilian Eyerich

München, Bavaria, Germany

Universitätsklinikum Regensburg

Regensburg, Bavaria, Germany

Andreas Eggert

Würzburg, Bavaria, Germany

Lars Freitag

Falkensee, Brandenburg, Germany

Förster-Funke-Allee 104

Kleinmachnow, Brandenburg, Germany

Silke Thies

Schwedt, Brandenburg, Germany

Christoph Hartl

Eltville, Hesse, Germany

Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie

Frankfurt am Main, Hesse, Germany

Pia Freyschmidt-Paul

Schwalmstadt, Hesse, Germany

Jutta Ramaker-Brunke

Braunschweig, Lower Saxony, Germany

Andreas Kleinheinz

Buxtehude, Lower Saxony, Germany

Marco Averbeck

Cloppenburg, Lower Saxony, Germany

Florian Schenck

Hanover, Lower Saxony, Germany

Ulrike Stein

Hanover, Lower Saxony, Germany

Holger Petering

Hildesheim, Lower Saxony, Germany

Silke Reinecke

Holzminden, Lower Saxony, Germany

Reinhard Knöll

Lüneburg, Lower Saxony, Germany

Christian Kock

Vechta, Lower Saxony, Germany

Gesundheitszentrum Winsen

Winsen, Lower Saxony, Germany

Andreas Timmel

Bergen auf Rügen, Mecklenburg-Vorpommern, Germany

Raimund Paech

Neubrandenburg, Mecklenburg-Vorpommern, Germany

Theaterplatz 9

Aachen, North Rhine-Westphalia, Germany

Isaak Effendy

Bielefeld, North Rhine-Westphalia, Germany

Volker Riesopp

Duisburg, North Rhine-Westphalia, Germany

Bernhard Korge

Düren, North Rhine-Westphalia, Germany

Herderstr.71 b

Düsseldorf, North Rhine-Westphalia, Germany

Dechant-Deckers-Straße 5-7

Eschweiler, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Christina Huerkamp

Euskirchen, North Rhine-Westphalia, Germany

Sebastian Rotterdam

Gelsenkirchen-Feldmark, North Rhine-Westphalia, Germany

Jörg Brinkmann

Gladbeck, North Rhine-Westphalia, Germany

Hautartzpraxis

Kleve, North Rhine-Westphalia, Germany

Rudolf Stadler

Minden, North Rhine-Westphalia, Germany

Rolf Ostendorf

Mönchengladbach, North Rhine-Westphalia, Germany

Athanasios Tsianakas

Münster, North Rhine-Westphalia, Germany

Stefanie Montag

Rheinbach, North Rhine-Westphalia, Germany

Hautarztpraxis, Steinfeldstr. 5

Stolberg, North Rhine-Westphalia, Germany

Oliver Mainusch

Velbert, North Rhine-Westphalia, Germany

Kurt-Kräcker-Str. 47

Wesel, North Rhine-Westphalia, Germany

Magnus Bell

Andernach, Rhineland-Palatinate, Germany

Ulrich Blaese

Bendorf, Rhineland-Palatinate, Germany

Schloss Straße 17

Koblenz, Rhineland-Palatinate, Germany

Petra Staubach-Renz

Mainz, Rhineland-Palatinate, Germany

Dirk Maaßen

Maxdorf, Rhineland-Palatinate, Germany

Marktstr. 20

Neuwied, Rhineland-Palatinate, Germany

Praxis für Haut- und Geschlechtskrankheiten - Allergologie - Am Johannisborn

Prüm, Rhineland-Palatinate, Germany

Ralph von Kiedrowski

Selters, Rhineland-Palatinate, Germany

Mohammad Asefi

Simmern, Rhineland-Palatinate, Germany

Karolin Schneider

Chemnitz, Saxony, Germany

Beatrice Gerlach

Dresden, Saxony, Germany

Liane John

Dresden, Saxony, Germany

Mary-Krebs-Straße 1

Dresden, Saxony, Germany

Stefan Beissert

Dresden, Saxony, Germany

Bernhard-Göring-Str. 162

Leipzig, Saxony, Germany

Riebeckstraße 65

Leipzig, Saxony, Germany

Schweizergartenstr. 2a

Wurzen, Saxony, Germany

Puschkinstr. 110

Eilenburg, Saxony-Anhalt, Germany

Franckestr. 1

Magdeburg, Saxony-Anhalt, Germany

Jens Ulrich

Quedlinburg, Saxony-Anhalt, Germany

Gabriela Fiedler

Weißenfels, Saxony-Anhalt, Germany

Harald Brüning

Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Christian Meewes

Neumünster, Schleswig-Holstein, Germany

Jens Thieme

Artern, Thuringia, Germany

Mario Pawlak

Heilbad Heiligenstadt, Thuringia, Germany

Raoul Hasert

Berlin, , Germany

Klaus Spickermann

Berlin, , Germany

Jens Olaf Mielcke

Berlin, , Germany

Albert-Einstein-Str. 2

Berlin, , Germany

Hautarztpraxis Zahn

Berlin, , Germany

Maria Manasterski

Berlin, , Germany

Martin Miehe

Berlin, , Germany

Uwe Schwichtenberg

Bremen, , Germany

Matthias Augustin

Hamburg, , Germany

Kristian Reich

Hamburg, , Germany

Christian Mensing

Hamburg, , Germany

Johannes-R.-Becher-Straße 24

Königs Wusterhausen, , Germany

Florian Kreuziger

Vilshofen, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 34913153 (View on PubMed)

Related Links

https://clinicaltrials.gov/ct2/show/NCT02626793?term=CC-10004-PPSO-002&rank=1

Expanded Access for CC-10004

Other Identifiers

CC-10004-PPSO-002

Identifier Type: -

Identifier Source: org_study_id