Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Psoriasis+1

+ Skin Diseases

+ Skin and Connective Tissue Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: August 2015
See protocol details

Summary

Principal SponsorAmgen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 3, 2015

Actual date on which the first participant was enrolled.

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.

Official TitleLong-term Documentation of the Utilization of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions (LAPIS-Pso)
NCT02626793
Principal SponsorAmgen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

391 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

PsoriasisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Papulosquamous

Criteria

5 inclusion criteria required to participate
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.
Show More Criteria
3 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 96 locations

Suspended

Marktstr. 20

Neuwied, GermanyOpen Marktstr. 20 in Google Maps
Suspended

Albert-Einstein-Str. 2

Berlin, Germany
Suspended

Hautarztpraxis Zahn

Berlin, Germany
Suspended

Gertraud Krähn-Senftleben

Blaubeuren Abbey, Germany
Completed96 Study Centers