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

NCT02626793 | Completed

• 1 other identifier: CC-10004-PPSO-002
• Study Type: observational
• Target: 391
• Locations: 1 country
• Sites: 96

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.

Conditions

Psoriasis

Keywords

Plaque psoriasis; Apremilast; Otezla®; LAPIS-Pso; Observational; CC-10004; non-interventional; Germany

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at Visit 2 from baseline

  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.

  Approximately 4 months

Secondary Outcomes (16)

• Change from Baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at all other visits from baseline.

  Up to approximately 52 weeks

• Change in the Physician Global Assessment (PGA) Score

  Up to approximately 52 weeks

• Percent Change in Percent of Affected Body Surface Area (BSA)

  Up to approximately 52 weeks

• Percent Change in the Psoriasis Area Severity Index (PASI) Score

  Up to approximately 52 weeks

• Change in the Patient's Global Assessment (PaGA)

  Up to approximately 52 weeks

Study Arms (2)

Patients with ≤ 1 conventional, systemic pre-treatment

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

Patients with > 1 conventional, systemic pre-treatment

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Amgen: lead

Study Sites (96)

Gertraud Krähn-Senftleben

Blaubeuren Abbey, Baden-Wurttemberg, 89143, Germany

Location

Ralf-Uwe Peter

Blaustein, Baden-Wurttemberg, 89134, Germany

Location

Regina Renner

Esslingen am Neckar, Baden-Wurttemberg, 73728, Germany

Location

Universitätsklinikum Heidelberg - Hautklinik

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Ina Reitenbach-Blindt

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

Kaiserstraße 231-233

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

Naomi Gerhardus

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

Johannes Glutsch

Karlsruhe, Baden-Wurttemberg, 76149, Germany

Location

Beate Schwarz

Langenau, Baden-Wurttemberg, 89129, Germany

Location

Astrid Schmieder

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Katharina Wroblewska

Spaichingen, Baden-Wurttemberg, 78549, Germany

Location

Michael Sticherling

Erlangen, Bavaria, 91054, Germany

Location

Hjalmar Kurzen

Freising, Bavaria, 85354, Germany

Location

Claus Jung

Germering, Bavaria, 82110, Germany

Location

Clarissa Allmacher

Hersbruck, Bavaria, 91217, Germany

Location

Ildiko Sugar-Bunk

Krumbach, Bavaria, 86381, Germany

Location

Sabine Anders

München, Bavaria, 80639, Germany

Location

Hortensia Pfannenstiel

München, Bavaria, 80802, Germany

Location

Technische Universität München - Kilian Eyerich

München, Bavaria, 80802, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Andreas Eggert

Würzburg, Bavaria, 97070, Germany

Location

Lars Freitag

Falkensee, Brandenburg, 14612, Germany

Location

Förster-Funke-Allee 104

Kleinmachnow, Brandenburg, 14532, Germany

Location

Silke Thies

Schwedt, Brandenburg, 16303, Germany

Location

Christoph Hartl

Eltville, Hesse, 65343, Germany

Location

Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie

Frankfurt am Main, Hesse, 60590, Germany

Location

Pia Freyschmidt-Paul

Schwalmstadt, Hesse, 34613, Germany

Location

Jutta Ramaker-Brunke

Braunschweig, Lower Saxony, 38114, Germany

Location

Andreas Kleinheinz

Buxtehude, Lower Saxony, 21614, Germany

Location

Marco Averbeck

Cloppenburg, Lower Saxony, 49661, Germany

Location

Florian Schenck

Hanover, Lower Saxony, 30159, Germany

Location

Ulrike Stein

Hanover, Lower Saxony, 30167, Germany

Location

Holger Petering

Hildesheim, Lower Saxony, 31134, Germany

Location

Silke Reinecke

Holzminden, Lower Saxony, 37603, Germany

Location

Reinhard Knöll

Lüneburg, Lower Saxony, 21335, Germany

Location

Christian Kock

Vechta, Lower Saxony, 49377, Germany

Location

Gesundheitszentrum Winsen

Winsen, Lower Saxony, 21423, Germany

Location

Andreas Timmel

Bergen auf Rügen, Mecklenburg-Vorpommern, 18528, Germany

Location

Raimund Paech

Neubrandenburg, Mecklenburg-Vorpommern, 17034, Germany

Location

Theaterplatz 9

Aachen, North Rhine-Westphalia, 52062, Germany

Location

Isaak Effendy

Bielefeld, North Rhine-Westphalia, 33647, Germany

Location

Volker Riesopp

Duisburg, North Rhine-Westphalia, 47249, Germany

Location

Bernhard Korge

Düren, North Rhine-Westphalia, 52349, Germany

Location

Herderstr.71 b

Düsseldorf, North Rhine-Westphalia, 40237, Germany

Location

Dechant-Deckers-Straße 5-7

Eschweiler, North Rhine-Westphalia, 52249, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Christina Huerkamp

Euskirchen, North Rhine-Westphalia, 53879, Germany

Location

Sebastian Rotterdam

Gelsenkirchen-Feldmark, North Rhine-Westphalia, 45883, Germany

Location

Jörg Brinkmann

Gladbeck, North Rhine-Westphalia, 45964, Germany

Location

Hautartzpraxis

Kleve, North Rhine-Westphalia, 47533, Germany

Location

Rudolf Stadler

Minden, North Rhine-Westphalia, 32429, Germany

Location

Rolf Ostendorf

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

Athanasios Tsianakas

Münster, North Rhine-Westphalia, 48149, Germany

Location

Stefanie Montag

Rheinbach, North Rhine-Westphalia, 53359, Germany

Location

Hautarztpraxis, Steinfeldstr. 5

Stolberg, North Rhine-Westphalia, 52222, Germany

Location

Oliver Mainusch

Velbert, North Rhine-Westphalia, 42551, Germany

Location

Kurt-Kräcker-Str. 47

Wesel, North Rhine-Westphalia, 46485, Germany

Location

Magnus Bell

Andernach, Rhineland-Palatinate, 56626, Germany

Location

Ulrich Blaese

Bendorf, Rhineland-Palatinate, 56170, Germany

Location

Schloss Straße 17

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

Petra Staubach-Renz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Dirk Maaßen

Maxdorf, Rhineland-Palatinate, 67133, Germany

Location

Marktstr. 20

Neuwied, Rhineland-Palatinate, 56564, Germany

Location

Praxis für Haut- und Geschlechtskrankheiten - Allergologie - Am Johannisborn

Prüm, Rhineland-Palatinate, 54595, Germany

Location

Ralph von Kiedrowski

Selters, Rhineland-Palatinate, 56242, Germany

Location

Mohammad Asefi

Simmern, Rhineland-Palatinate, 55469, Germany

Location

Karolin Schneider

Chemnitz, Saxony, 09116, Germany

Location

Beatrice Gerlach

Dresden, Saxony, 01097, Germany

Location

Liane John

Dresden, Saxony, 01159, Germany

Location

Mary-Krebs-Straße 1

Dresden, Saxony, 01219, Germany

Location

Stefan Beissert

Dresden, Saxony, 01307, Germany

Location

Bernhard-Göring-Str. 162

Leipzig, Saxony, 04277, Germany

Location

Riebeckstraße 65

Leipzig, Saxony, 04317, Germany

Location

Schweizergartenstr. 2a

Wurzen, Saxony, 04808, Germany

Location

Puschkinstr. 110

Eilenburg, Saxony-Anhalt, 04838, Germany

Location

Franckestr. 1

Magdeburg, Saxony-Anhalt, 39104, Germany

Location

Jens Ulrich

Quedlinburg, Saxony-Anhalt, 06484, Germany

Location

Gabriela Fiedler

Weißenfels, Saxony-Anhalt, 06667, Germany

Location

Harald Brüning

Kiel, Schleswig-Holstein, 24148, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Christian Meewes

Neumünster, Schleswig-Holstein, 24534, Germany

Location

Jens Thieme

Artern, Thuringia, 06556, Germany

Location

Mario Pawlak

Heilbad Heiligenstadt, Thuringia, 37308, Germany

Location

Raoul Hasert

Berlin, 10117, Germany

Location

Klaus Spickermann

Berlin, 10247, Germany

Location

Jens Olaf Mielcke

Berlin, 10777, Germany

Location

Albert-Einstein-Str. 2

Berlin, 12489, Germany

Location

Hautarztpraxis Zahn

Berlin, 13187, Germany

Location

Maria Manasterski

Berlin, 13507, Germany

Location

Martin Miehe

Berlin, 13507, Germany

Location

Uwe Schwichtenberg

Bremen, 28779, Germany

Location

Matthias Augustin

Hamburg, 20246, Germany

Location

Kristian Reich

Hamburg, 20354, Germany

Location

Christian Mensing

Hamburg, 22391, Germany

Location

Johannes-R.-Becher-Straße 24

Königs Wusterhausen, 15711, Germany

Location

Florian Kreuziger

Vilshofen, 94474, Germany

Location

Related Publications (1)

• 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.

  PMID: 34913153 DERIVED

Related Links

• Expanded Access for CC-10004

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: December 10, 2015
• Study Start: August 3, 2015
• Primary Completion: June 8, 2017
• Study Completion: June 14, 2018
• Last Updated: February 8, 2022

Record last verified: 2022-02

Locations

DE (96)