NCT02626793

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 391 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Timeline

• Start date: 2015-08-03
• Primary completion: 2017-06-08
• Completion: 2018-06-14
• First posted: 2015-12-10
• Last updated: 2022-02-08

Locations

96 sites across 1 country: Germany