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PsoriasisNCT02626793

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

An observational study of Psoriasis, run by Amgen at 96 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
How many people
391 participants
Where
96 sitesGermany
Study dates
3 Aug 2015to 14 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

96 sites in 1 country.

96 sites in 1 country

Germany96 sites

  • Theaterplatz 9

    Aachen, North Rhine-Westphalia, 52062

  • Magnus Bell

    Andernach, Rhineland-Palatinate, 56626

  • Jens Thieme

    Artern, Thuringia, 06556

  • Ulrich Blaese

    Bendorf, Rhineland-Palatinate, 56170

  • Andreas Timmel

    Bergen auf Rügen, Mecklenburg-Vorpommern, 18528

  • Raoul Hasert

    Berlin, 10117

  • Klaus Spickermann

    Berlin, 10247

  • Jens Olaf Mielcke

    Berlin, 10777

  • Albert-Einstein-Str. 2

    Berlin, 12489

  • Hautarztpraxis Zahn

    Berlin, 13187

  • Maria Manasterski

    Berlin, 13507

  • Martin Miehe

    Berlin, 13507

  • Isaak Effendy

    Bielefeld, North Rhine-Westphalia, 33647

  • Gertraud Krähn-Senftleben

    Blaubeuren Abbey, Baden-Wurttemberg, 89143

  • Ralf-Uwe Peter

    Blaustein, Baden-Wurttemberg, 89134

  • Jutta Ramaker-Brunke

    Braunschweig, Lower Saxony, 38114

  • Uwe Schwichtenberg

    Bremen, 28779

  • Andreas Kleinheinz

    Buxtehude, Lower Saxony, 21614

  • Karolin Schneider

    Chemnitz, Saxony, 09116

  • Marco Averbeck

    Cloppenburg, Lower Saxony, 49661

  • Beatrice Gerlach

    Dresden, Saxony, 01097

  • Liane John

    Dresden, Saxony, 01159

  • Mary-Krebs-Straße 1

    Dresden, Saxony, 01219

  • Stefan Beissert

    Dresden, Saxony, 01307

  • Volker Riesopp

    Duisburg, North Rhine-Westphalia, 47249

  • Bernhard Korge

    Düren, North Rhine-Westphalia, 52349

  • Herderstr.71 b

    Düsseldorf, North Rhine-Westphalia, 40237

  • Puschkinstr. 110

    Eilenburg, Saxony-Anhalt, 04838

  • Christoph Hartl

    Eltville, Hesse, 65343

  • Michael Sticherling

    Erlangen, Bavaria, 91054

  • Dechant-Deckers-Straße 5-7

    Eschweiler, North Rhine-Westphalia, 52249

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Regina Renner

    Esslingen am Neckar, Baden-Wurttemberg, 73728

  • Christina Huerkamp

    Euskirchen, North Rhine-Westphalia, 53879

  • Lars Freitag

    Falkensee, Brandenburg, 14612

  • Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie

    Frankfurt am Main, Hesse, 60590

  • Hjalmar Kurzen

    Freising, Bavaria, 85354

  • Sebastian Rotterdam

    Gelsenkirchen-Feldmark, North Rhine-Westphalia, 45883

  • Claus Jung

    Germering, Bavaria, 82110

  • Jörg Brinkmann

    Gladbeck, North Rhine-Westphalia, 45964

  • Matthias Augustin

    Hamburg, 20246

  • Kristian Reich

    Hamburg, 20354

  • Christian Mensing

    Hamburg, 22391

  • Florian Schenck

    Hanover, Lower Saxony, 30159

  • Ulrike Stein

    Hanover, Lower Saxony, 30167

  • Universitätsklinikum Heidelberg - Hautklinik

    Heidelberg, Baden-Wurttemberg, 69120

  • Mario Pawlak

    Heilbad Heiligenstadt, Thuringia, 37308

  • Clarissa Allmacher

    Hersbruck, Bavaria, 91217

  • Holger Petering

    Hildesheim, Lower Saxony, 31134

  • Silke Reinecke

    Holzminden, Lower Saxony, 37603

  • Ina Reitenbach-Blindt

    Karlsruhe, Baden-Wurttemberg, 76133

  • Kaiserstraße 231-233

    Karlsruhe, Baden-Wurttemberg, 76133

  • Naomi Gerhardus

    Karlsruhe, Baden-Wurttemberg, 76133

  • Johannes Glutsch

    Karlsruhe, Baden-Wurttemberg, 76149

  • Harald Brüning

    Kiel, Schleswig-Holstein, 24148

  • Förster-Funke-Allee 104

    Kleinmachnow, Brandenburg, 14532

  • Hautartzpraxis

    Kleve, North Rhine-Westphalia, 47533

  • Schloss Straße 17

    Koblenz, Rhineland-Palatinate, 56068

  • Johannes-R.-Becher-Straße 24

    Königs Wusterhausen, 15711

  • Ildiko Sugar-Bunk

    Krumbach, Bavaria, 86381

  • Beate Schwarz

    Langenau, Baden-Wurttemberg, 89129

  • Bernhard-Göring-Str. 162

    Leipzig, Saxony, 04277

  • Riebeckstraße 65

    Leipzig, Saxony, 04317

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23562

  • Reinhard Knöll

    Lüneburg, Lower Saxony, 21335

  • Franckestr. 1

    Magdeburg, Saxony-Anhalt, 39104

  • Petra Staubach-Renz

    Mainz, Rhineland-Palatinate, 55131

  • Astrid Schmieder

    Mannheim, Baden-Wurttemberg, 68167

  • Dirk Maaßen

    Maxdorf, Rhineland-Palatinate, 67133

  • Rudolf Stadler

    Minden, North Rhine-Westphalia, 32429

  • Rolf Ostendorf

    Mönchengladbach, North Rhine-Westphalia, 41061

  • Sabine Anders

    München, Bavaria, 80639

  • Hortensia Pfannenstiel

    München, Bavaria, 80802

  • Technische Universität München - Kilian Eyerich

    München, Bavaria, 80802

  • Athanasios Tsianakas

    Münster, North Rhine-Westphalia, 48149

  • Raimund Paech

    Neubrandenburg, Mecklenburg-Vorpommern, 17034

  • Christian Meewes

    Neumünster, Schleswig-Holstein, 24534

  • Marktstr. 20

    Neuwied, Rhineland-Palatinate, 56564

  • Praxis für Haut- und Geschlechtskrankheiten - Allergologie - Am Johannisborn

    Prüm, Rhineland-Palatinate, 54595

  • Jens Ulrich

    Quedlinburg, Saxony-Anhalt, 06484

  • Universitätsklinikum Regensburg

    Regensburg, Bavaria, 93053

  • Stefanie Montag

    Rheinbach, North Rhine-Westphalia, 53359

  • Pia Freyschmidt-Paul

    Schwalmstadt, Hesse, 34613

  • Silke Thies

    Schwedt, Brandenburg, 16303

  • Ralph von Kiedrowski

    Selters, Rhineland-Palatinate, 56242

  • Mohammad Asefi

    Simmern, Rhineland-Palatinate, 55469

  • Katharina Wroblewska

    Spaichingen, Baden-Wurttemberg, 78549

  • Hautarztpraxis, Steinfeldstr. 5

    Stolberg, North Rhine-Westphalia, 52222

  • Christian Kock

    Vechta, Lower Saxony, 49377

  • Oliver Mainusch

    Velbert, North Rhine-Westphalia, 42551

  • Florian Kreuziger

    Vilshofen, 94474

  • Gabriela Fiedler

    Weißenfels, Saxony-Anhalt, 06667

  • Kurt-Kräcker-Str. 47

    Wesel, North Rhine-Westphalia, 46485

  • Gesundheitszentrum Winsen

    Winsen, Lower Saxony, 21423

  • Andreas Eggert

    Würzburg, Bavaria, 97070

  • Schweizergartenstr. 2a

    Wurzen, Saxony, 04808

Other trials in Germany

About this study

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

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.

Read the 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
Keywords
Plaque psoriasis, Apremilast, Otezla®, LAPIS-Pso, Observational, CC-10004, non-interventional, Germany
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02626793
Study groupRoleWhat they receive
Patients with ≤ 1 conventional, systemic pre-treatmentAfter failure (inadequate response/intolerance) to or contraindication for ≤ 1 conventional, systemic pre-treatment
Patients with > 1 conventional, systemic pre-treatmentAfter failure (inadequate response/intolerance) to or contraindication for > 1 conventional, systemic pre-treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately 4 months

Secondary outcomes (16)

  1. 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.

    Measured: Up to approximately 52 weeks

  2. 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.

    Measured: Up to approximately 52 weeks

  3. 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.

    Measured: Up to approximately 52 weeks

  4. 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.

    Measured: Up to approximately 52 weeks

  5. 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.

    Measured: Up to approximately 52 weeks

  6. 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.

    Measured: Approximately 4 months

  7. 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).

    Measured: Approximately 13 months

  8. 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.

    Measured: Up to approximately 52 weeks

  9. 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.

    Measured: Up to approximately 52 weeks

  10. 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.

    Measured: Up to approximately 52 weeks

  11. 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.

    Measured: Up to approximately 52 weeks

  12. 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.

    Measured: Up to approximately 52 weeks

  13. 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.

    Measured: Up to approximately 52 weeks

  14. 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.

    Measured: Up to approximately 52 weeks

  15. 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.

    Measured: Up to approximately 52 weeks

  16. 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.

    Measured: Up to approximately 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2015 (estimated)
  2. Study start3 Aug 2015
  3. Primary completion8 Jun 2017
  4. Study completion14 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
391 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02626793
Sponsor's protocol ID
CC-10004-PPSO-002
Status last verified
Feb 2022
First submitted
29 Jul 2015
Last updated
8 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34913153

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis, run by Amgen at 96 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at Visit 2 from baseline (time frame: Approximately 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02626793, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.

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