A Study of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions
- Conditions
- Psoriasis
- Registration Number
- NCT02626793
- Lead Sponsor
- Amgen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 391
- 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
- Pregnancy
- Hypersensitivity to apremilast or any of the excipients of the film-coated tablet
- Other criteria according to the Summary of product characteristics (SmPC).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at Visit 2 from baseline Approximately 4 months 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.
- Secondary Outcome Measures
Name Time Method Percent Change in the Psoriasis Area Severity Index (PASI) Score Up to approximately 52 weeks Psoriasis Area Severity Index (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 total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.
Change in the Patient's Global Assessment (PaGA) Up to approximately 52 weeks The PaGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the Plaque-Psoriasis by the patient.
Change in Itch (Pruritus) (Visual Analogue Scale; VAS) Up to approximately 52 weeks The Itch Visual Analog Scores (VAS) is used to measure the amount of itch a participant experiences. Participants are asked: How much itch do you actually experience? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease.
Change in Scalp Involvement -Physician's Global Assessment (PGA) Up to approximately 52 weeks PGA: 5-point scale for the physician's global assessment of the severity of scalp psoriasis.
Change in Pain (Visual Analogue Scale; VAS) Up to approximately 52 weeks The Pain Visual Analog Scores (VAS) is used to measure the amount of pain a participant experiences. Participants are asked: How much pain do you actually experience? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease.
Adverse Events (AEs) Up to approximately 52 weeks All Serious Adverse Events (SAEs), irrespective of relationship to Apremilast, and all non-serious AEs considered at least possibly related to Apremilast administration \[non-serious adverse drug reactions (NS ADRs)\], must be recorded within 24 hours of the physician's knowledge to the Sponsors' Drug Safety Department. AEs will be reported by the sponsor as required to Regulatory Authorities and Ethics Committees as applicable, in accordance with the national requirements for marketing authorization holders.
Change in Nail Involvement Fingernail - Patient's Global Assessment (PaGA) Up to approximately 52 weeks Fingernail Patient Global Assessment ; 5-point scale on the patient's global assessment of the fingernail involvement, substituted with a 0-100 Visual analog scale (VAS) for the assessment of the impairment caused by this nail involvement.
Change in Palmoplantar involvement - Palmoplantar physician's global assessment (PGA) Up to approximately 52 weeks PGA: 5-point scale for the physician's global assessment of the severity of palmoplantar involvement.
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 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.
Patient Preference Questionnaire (PPQ) Approximately 4 months PPQ is a questionnaire consisting of 5 questions. PPQ asks the patient for his preference of the actual therapy versus the previous systemic therapy.
Patient Satisfaction (Systemic Therapy Adherence Questionnaire, STAQ) Approximately 13 months STAQ; patient questionnaire on patient benefit, communication physician/patient, patient knowledge, and treatment satisfaction with the current systemic treatment (38 questions).
Change in the Physician Global Assessment (PGA) Score Up to approximately 52 weeks The PGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the Plaque-Psoriasis.
Percent Change in Percent of Affected Body Surface Area (BSA) Up to approximately 52 weeks BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmer surface or "handprint" excluding DIPs), which equates to approximately 1% of total body surface area.
Change in Scalp Involvement - Patient's Global Assessment (PaGA) Up to approximately 52 weeks PaGA: 5-point scale for the patient's global assessment of the severity of scalp psoriasis.
Change in Nail Involvement - Target Nail Psoriasis Severity Index (NAPSI) Up to approximately 52 weeks NAPSI: Assessment of target fingernail for nail bed and nail matrix involvement, each can be scored 0-4. Total score ranges from 0-8.
Change in Palmoplantar involvement - Palmoplantar patient's global assessment (PaGA) Up to approximately 52 weeks PaGA: 5-point scale for the patient's global assessment of the severity of palmoplantar involvement.
Trial Locations
- Locations (96)
Gertraud Krähn-Senftleben
🇩🇪Blaubeuren, Baden-Württemberg, Germany
Clarissa Allmacher
🇩🇪Hersbruck, Bayern, Germany
Ildiko Sugar-Bunk
🇩🇪Krumbach, Bayern, Germany
Hortensia Pfannenstiel
🇩🇪München, Bayern, Germany
Technische Universität München - Kilian Eyerich
🇩🇪München, Bayern, Germany
Florian Schenck
🇩🇪Hannover, Niedersachsen, Germany
Holger Petering
🇩🇪Hildesheim, Niedersachsen, Germany
Ulrike Stein
🇩🇪Hannover, Niedersachsen, Germany
Christian Kock
🇩🇪Vechta, Niedersachsen, Germany
Bernhard Korge
🇩🇪Düren, Nordrhein-Westfalen, Germany
Dechant-Deckers-Straße 5-7
🇩🇪Eschweiler, Nordrhein-Westfalen, Germany
Jörg Brinkmann
🇩🇪Gladbeck, Nordrhein-Westfalen, Germany
Hautartzpraxis
🇩🇪Kleve, Nordrhein-Westfalen, Germany
Rolf Ostendorf
🇩🇪Mönchengladbach, Nordrhein-Westfalen, Germany
Athanasios Tsianakas
🇩🇪Münster, Nordrhein-Westfalen, Germany
Rudolf Stadler
🇩🇪Minden, Nordrhein-Westfalen, Germany
Stefanie Montag
🇩🇪Rheinbach, Nordrhein-Westfalen, Germany
Hautarztpraxis, Steinfeldstr. 5
🇩🇪Stolberg (Rheinland), Nordrhein-Westfalen, Germany
Oliver Mainusch
🇩🇪Velbert, Nordrhein-Westfalen, Germany
Kurt-Kräcker-Str. 47
🇩🇪Wesel, Nordrhein-Westfalen, Germany
Magnus Bell
🇩🇪Andernach, Rheinland-Pfalz, Germany
Schloss Straße 17
🇩🇪Koblenz, Rheinland-Pfalz, Germany
Petra Staubach-Renz
🇩🇪Mainz, Rheinland-Pfalz, Germany
Dirk Maaßen
🇩🇪Maxdorf, Rheinland-Pfalz, Germany
Marktstr. 20
🇩🇪Neuwied, Rheinland-Pfalz, Germany
Praxis für Haut- und Geschlechtskrankheiten - Allergologie - Am Johannisborn
🇩🇪Prüm, Rheinland-Pfalz, Germany
Ralph von Kiedrowski
🇩🇪Selters, Rheinland-Pfalz, Germany
Mohammad Asefi
🇩🇪Simmern, Rheinland-Pfalz, Germany
Puschkinstr. 110
🇩🇪Eilenburg, Sachsen-Anhalt, Germany
Franckestr. 1
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
Jens Ulrich
🇩🇪Quedlinburg, Sachsen-Anhalt, Germany
Gabriela Fiedler
🇩🇪Weißenfels, Sachsen-Anhalt, Germany
Karolin Schneider
🇩🇪Chemnitz, Sachsen, Germany
Beatrice Gerlach
🇩🇪Dresden, Sachsen, Germany
Mary-Krebs-Straße 1
🇩🇪Dresden, Sachsen, Germany
Liane John
🇩🇪Dresden, Sachsen, Germany
Stefan Beissert
🇩🇪Dresden, Sachsen, Germany
Bernhard-Göring-Str. 162
🇩🇪Leipzig, Sachsen, Germany
Riebeckstraße 65
🇩🇪Leipzig, Sachsen, Germany
Schweizergartenstr. 2a
🇩🇪Wurzen, Sachsen, Germany
Christian Meewes
🇩🇪Neumünster, Schleswig-Holstein, Germany
Jens Olaf Mielcke
🇩🇪Berlin, Germany
Jens Thieme
🇩🇪Artern, Thüringen, Germany
Mario Pawlak
🇩🇪Heiligenstadt, Thüringen, Germany
Harald Brüning
🇩🇪Kiel, Schleswig-Holstein, Germany
Raoul Hasert
🇩🇪Berlin, Germany
Hautarztpraxis Zahn
🇩🇪Berlin, Germany
Albert-Einstein-Str. 2
🇩🇪Berlin, Germany
Uwe Schwichtenberg
🇩🇪Bremen, Germany
Christian Mensing
🇩🇪Hamburg, Germany
Klaus Spickermann
🇩🇪Berlin, Germany
Maria Manasterski
🇩🇪Berlin, Germany
Kristian Reich
🇩🇪Hamburg, Germany
Regina Renner
🇩🇪Esslingen am Neckar, Baden-Württemberg, Germany
Universitätsklinikum Heidelberg - Hautklinik
🇩🇪Heidelberg, Baden-Württemberg, Germany
Ralf-Uwe Peter
🇩🇪Blaustein, Baden-Württemberg, Germany
Naomi Gerhardus
🇩🇪Karlsruhe, Baden-Württemberg, Germany
Ina Reitenbach-Blindt
🇩🇪Karlsruhe, Baden-Württemberg, Germany
Raimund Paech
🇩🇪Neubrandenburg, Mecklenburg-Vorpommern, Germany
Christoph Hartl
🇩🇪Eltville, Hessen, Germany
Pia Freyschmidt-Paul
🇩🇪Schwalmstadt, Hessen, Germany
Kaiserstraße 231-233
🇩🇪Karlsruhe, Baden-Württemberg, Germany
Johannes Glutsch
🇩🇪Karlsruhe, Baden-Württemberg, Germany
Beate Schwarz
🇩🇪Langenau, Baden-Württemberg, Germany
Hjalmar Kurzen
🇩🇪Freising, Bayern, Germany
Claus Jung
🇩🇪Germering, Bayern, Germany
Astrid Schmieder
🇩🇪Mannheim, Baden-Württemberg, Germany
Katharina Wroblewska
🇩🇪Spaichingen, Baden-Württemberg, Germany
Michael Sticherling
🇩🇪Erlangen, Bayern, Germany
Sabine Anders
🇩🇪München, Bayern, Germany
Andreas Eggert
🇩🇪Würzburg, Bayern, Germany
Silke Thies
🇩🇪Schwedt, Brandenburg, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Bayern, Germany
Förster-Funke-Allee 104
🇩🇪Kleinmachnow, Brandenburg, Germany
Lars Freitag
🇩🇪Falkensee, Brandenburg, Germany
Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
🇩🇪Frankfurt am Main, Hessen, Germany
Andreas Timmel
🇩🇪Bergen, Mecklenburg-Vorpommern, Germany
Theaterplatz 9
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Jutta Ramaker-Brunke
🇩🇪Braunschweig, Niedersachsen, Germany
Andreas Kleinheinz
🇩🇪Buxtehude, Niedersachsen, Germany
Reinhard Knöll
🇩🇪Lüneburg, Niedersachsen, Germany
Marco Averbeck
🇩🇪Cloppenburg, Niedersachsen, Germany
Silke Reinecke
🇩🇪Holzminden, Niedersachsen, Germany
Herderstr.71 b
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany
Gesundheitszentrum Winsen
🇩🇪Winsen, Niedersachsen, Germany
Isaak Effendy
🇩🇪Bielefeld, Nordrhein-Westfalen, Germany
Volker Riesopp
🇩🇪Duisburg, Nordrhein-Westfalen, Germany
Universitätsklinikum Essen
🇩🇪Essen, Nordrhein-Westfalen, Germany
Christina Huerkamp
🇩🇪Euskirchen, Nordrhein-Westfalen, Germany
Sebastian Rotterdam
🇩🇪Gelsenkirchen-Feldmark, Nordrhein-Westfalen, Germany
Ulrich Blaese
🇩🇪Bendorf, Rheinland Pfalz, Germany
Matthias Augustin
🇩🇪Hamburg, Germany
Martin Miehe
🇩🇪Berlin, Germany
Johannes-R.-Becher-Straße 24
🇩🇪Königs Wusterhausen, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Schleswig-Holstein, Germany
Florian Kreuziger
🇩🇪Vilshofen, Germany