Study to Evaluate the Benefits for the Patient Associated With the Treatment of Plaque Psoriasis With Apremilast After Other Systemic Treatment in Conditions of Clinical Practice in Spain (APPROPIATE)

Amgen

Status: Completed

Conditions: Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT03539419

U1111-1212-0643 (Registry Identifier)

CC-10004-PSOR-017

Details and patient eligibility

About

Observational, prospective and multicenter study in approximately 30 sites nationwide. The investigators participating in this study will be dermatologists specializing in this pathology.

The present study will include adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice. Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study. Therefore, the choice of the therapeutic strategy will be made independently by the physician.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male and female (≥ 18 years).
• Patients diagnosed with moderate to severe plaque psoriasis and for which treatment with apremilast is indicated according to the doctor's criteria (established before the patient enters the study) and according to the specifications of the medication's data sheet
• Patients with available data regarding the PASI and DLQI assessments at the moment of initiating treatment with apremilast.
• Patients for whom, according to the physician's criteria (established prior to patient's entry into the study) and according to the specifications of the drug's prescribing information, apremilast treatment is indicated.
• All patients who, according to the routine clinical practice, initiated apremilast treatment for the first time 3 months (+/- 4 weeks) before their inclusion in the study (patients may or may not have completed 3 months of apremilast treatment).
• Patients who have previously received at least one systemic treatment for moderate to severe plaque psoriasis.
• Patients who have not previously been treated with a biological agent for moderate to severe plaque psoriasis.
• Patients who agree to participate in the study by signing the informed consent.
• Patients who are able to understand and complete the questionnaires specified in the study protocol.

Exclusion criteria

• Patients participating in another study at the time of entering the study.

Trial design

153 participants in 1 patient group

Patients with plaque psoriasis on apremilast

Description:

Adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice.