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

Psoriasis Clinical Trial

Official title:

Long-term Documentation of the Utilization of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions (LAPIS-Pso)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626793
• Other study ID #: CC-10004-PPSO-002
• Status: Completed
• Start date: August 3, 2015
• Est. completion date: June 14, 2018

Study information

• Verified date: February 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: June 14, 2018
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Germany	Theaterplatz 9	Aachen	Nordrhein-Westfalen
Germany	Magnus Bell	Andernach	Rheinland-Pfalz
Germany	Jens Thieme	Artern	Thüringen
Germany	Ulrich Blaese	Bendorf	Rheinland Pfalz
Germany	Andreas Timmel	Bergen	Mecklenburg-Vorpommern
Germany	Albert-Einstein-Str. 2	Berlin
Germany	Hautarztpraxis Zahn	Berlin
Germany	Jens Olaf Mielcke	Berlin
Germany	Klaus Spickermann	Berlin
Germany	Maria Manasterski	Berlin
Germany	Martin Miehe	Berlin
Germany	Raoul Hasert	Berlin
Germany	Isaak Effendy	Bielefeld	Nordrhein-Westfalen
Germany	Gertraud Krähn-Senftleben	Blaubeuren	Baden-Württemberg
Germany	Ralf-Uwe Peter	Blaustein	Baden-Württemberg
Germany	Jutta Ramaker-Brunke	Braunschweig	Niedersachsen
Germany	Uwe Schwichtenberg	Bremen
Germany	Andreas Kleinheinz	Buxtehude	Niedersachsen
Germany	Karolin Schneider	Chemnitz	Sachsen
Germany	Marco Averbeck	Cloppenburg	Niedersachsen
Germany	Beatrice Gerlach	Dresden	Sachsen
Germany	Liane John	Dresden	Sachsen
Germany	Mary-Krebs-Straße 1	Dresden	Sachsen
Germany	Stefan Beissert	Dresden	Sachsen
Germany	Volker Riesopp	Duisburg	Nordrhein-Westfalen
Germany	Bernhard Korge	Düren	Nordrhein-Westfalen
Germany	Herderstr.71 b	Düsseldorf	Nordrhein-Westfalen
Germany	Puschkinstr. 110	Eilenburg	Sachsen-Anhalt
Germany	Christoph Hartl	Eltville	Hessen
Germany	Michael Sticherling	Erlangen	Bayern
Germany	Dechant-Deckers-Straße 5-7	Eschweiler	Nordrhein-Westfalen
Germany	Universitätsklinikum Essen	Essen	Nordrhein-Westfalen
Germany	Regina Renner	Esslingen am Neckar	Baden-Württemberg
Germany	Christina Huerkamp	Euskirchen	Nordrhein-Westfalen
Germany	Lars Freitag	Falkensee	Brandenburg
Germany	Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie	Frankfurt am Main	Hessen
Germany	Hjalmar Kurzen	Freising	Bayern
Germany	Sebastian Rotterdam	Gelsenkirchen-Feldmark	Nordrhein-Westfalen
Germany	Claus Jung	Germering	Bayern
Germany	Jörg Brinkmann	Gladbeck	Nordrhein-Westfalen
Germany	Christian Mensing	Hamburg
Germany	Kristian Reich	Hamburg
Germany	Matthias Augustin	Hamburg
Germany	Florian Schenck	Hannover	Niedersachsen
Germany	Ulrike Stein	Hannover	Niedersachsen
Germany	Universitätsklinikum Heidelberg - Hautklinik	Heidelberg	Baden-Württemberg
Germany	Mario Pawlak	Heiligenstadt	Thüringen
Germany	Clarissa Allmacher	Hersbruck	Bayern
Germany	Holger Petering	Hildesheim	Niedersachsen
Germany	Silke Reinecke	Holzminden	Niedersachsen
Germany	Ina Reitenbach-Blindt	Karlsruhe	Baden-Württemberg
Germany	Johannes Glutsch	Karlsruhe	Baden-Württemberg
Germany	Kaiserstraße 231-233	Karlsruhe	Baden-Württemberg
Germany	Naomi Gerhardus	Karlsruhe	Baden-Württemberg
Germany	Harald Brüning	Kiel	Schleswig-Holstein
Germany	Förster-Funke-Allee 104	Kleinmachnow	Brandenburg
Germany	Hautartzpraxis	Kleve	Nordrhein-Westfalen
Germany	Schloss Straße 17	Koblenz	Rheinland-Pfalz
Germany	Johannes-R.-Becher-Straße 24	Königs Wusterhausen
Germany	Ildiko Sugar-Bunk	Krumbach	Bayern
Germany	Beate Schwarz	Langenau	Baden-Württemberg
Germany	Bernhard-Göring-Str. 162	Leipzig	Sachsen
Germany	Riebeckstraße 65	Leipzig	Sachsen
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	Reinhard Knöll	Lüneburg	Niedersachsen
Germany	Franckestr. 1	Magdeburg	Sachsen-Anhalt
Germany	Petra Staubach-Renz	Mainz	Rheinland-Pfalz
Germany	Astrid Schmieder	Mannheim	Baden-Württemberg
Germany	Dirk Maaßen	Maxdorf	Rheinland-Pfalz
Germany	Rudolf Stadler	Minden	Nordrhein-Westfalen
Germany	Rolf Ostendorf	Mönchengladbach	Nordrhein-Westfalen
Germany	Hortensia Pfannenstiel	München	Bayern
Germany	Sabine Anders	München	Bayern
Germany	Technische Universität München - Kilian Eyerich	München	Bayern
Germany	Athanasios Tsianakas	Münster	Nordrhein-Westfalen
Germany	Raimund Paech	Neubrandenburg	Mecklenburg-Vorpommern
Germany	Christian Meewes	Neumünster	Schleswig-Holstein
Germany	Marktstr. 20	Neuwied	Rheinland-Pfalz
Germany	Praxis für Haut- und Geschlechtskrankheiten - Allergologie - Am Johannisborn	Prüm	Rheinland-Pfalz
Germany	Jens Ulrich	Quedlinburg	Sachsen-Anhalt
Germany	Universitätsklinikum Regensburg	Regensburg	Bayern
Germany	Stefanie Montag	Rheinbach	Nordrhein-Westfalen
Germany	Pia Freyschmidt-Paul	Schwalmstadt	Hessen
Germany	Silke Thies	Schwedt	Brandenburg
Germany	Ralph von Kiedrowski	Selters	Rheinland-Pfalz
Germany	Mohammad Asefi	Simmern	Rheinland-Pfalz
Germany	Katharina Wroblewska	Spaichingen	Baden-Württemberg
Germany	Hautarztpraxis, Steinfeldstr. 5	Stolberg (Rheinland)	Nordrhein-Westfalen
Germany	Christian Kock	Vechta	Niedersachsen
Germany	Oliver Mainusch	Velbert	Nordrhein-Westfalen
Germany	Florian Kreuziger	Vilshofen
Germany	Gabriela Fiedler	Weißenfels	Sachsen-Anhalt
Germany	Kurt-Kräcker-Str. 47	Wesel	Nordrhein-Westfalen
Germany	Gesundheitszentrum Winsen	Winsen	Niedersachsen
Germany	Andreas Eggert	Würzburg	Bayern
Germany	Schweizergartenstr. 2a	Wurzen	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline in the Dermatology Life Quality Index (DLQI) = 5 or improvement in DLQI by = 5 points at all other visits 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.	Up to approximately 52 weeks
Secondary	Change in the Physician Global Assessment (PGA) Score	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.	Up to approximately 52 weeks
Secondary	Percent Change in Percent of Affected Body Surface Area (BSA)	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.	Up to approximately 52 weeks
Secondary	Percent Change in the Psoriasis Area Severity Index (PASI) Score	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.	Up to approximately 52 weeks
Secondary	Change in the Patient's Global Assessment (PaGA)	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.	Up to approximately 52 weeks
Secondary	Patient Preference Questionnaire (PPQ)	PPQ is a questionnaire consisting of 5 questions. PPQ asks the patient for his preference of the actual therapy versus the previous systemic therapy.	Approximately 4 months
Secondary	Patient Satisfaction (Systemic Therapy Adherence Questionnaire, STAQ)	STAQ; patient questionnaire on patient benefit, communication physician/patient, patient knowledge, and treatment satisfaction with the current systemic treatment (38 questions).	Approximately 13 months
Secondary	Change in Pain (Visual Analogue Scale; VAS)	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.	Up to approximately 52 weeks
Secondary	Adverse Events (AEs)	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.	Up to approximately 52 weeks
Secondary	Change in Itch (Pruritus) (Visual Analogue Scale; VAS)	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.	Up to approximately 52 weeks
Secondary	Change in Scalp Involvement -Physician's Global Assessment (PGA)	PGA: 5-point scale for the physician's global assessment of the severity of scalp psoriasis.	Up to approximately 52 weeks
Secondary	Change in Scalp Involvement - Patient's Global Assessment (PaGA)	PaGA: 5-point scale for the patient's global assessment of the severity of scalp psoriasis.	Up to approximately 52 weeks
Secondary	Change in Nail Involvement - Target Nail Psoriasis Severity Index (NAPSI)	NAPSI: Assessment of target fingernail for nail bed and nail matrix involvement, each can be scored 0-4. Total score ranges from 0-8.	Up to approximately 52 weeks
Secondary	Change in Nail Involvement Fingernail - Patient's Global Assessment (PaGA)	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.	Up to approximately 52 weeks
Secondary	Change in Palmoplantar involvement - Palmoplantar physician's global assessment (PGA)	PGA: 5-point scale for the physician's global assessment of the severity of palmoplantar involvement.	Up to approximately 52 weeks
Secondary	Change in Palmoplantar involvement - Palmoplantar patient's global assessment (PaGA)	PaGA: 5-point scale for the patient's global assessment of the severity of palmoplantar involvement.	Up to approximately 52 weeks

External Links

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