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

Amgen

Status: Completed

Conditions: Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT02626793

CC-10004-PPSO-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 391 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

391 participants in 2 patient groups

Patients with ≤ 1 conventional, systemic pre-treatment

Description:

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

Patients with > 1 conventional, systemic pre-treatment

Description:

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