Observational Study of Apremilast in Patients With Psoriasis in The Netherlands (APRIL)

Amgen

Status: Completed

Conditions: Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT02652494

CC-10004-PSOR-014

Details and patient eligibility

About

This is a multicenter, prospective, non-interventional, observational single arm study.

Two-hundred patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the SPC of apremilast (Otezla®). Recruitment will continue until 200 patients have entered the study. Each patient will be followed for 12 months.

Full description

Baseline Demographics, disease characteristics and medication history prior to start of treatment with apremilast will be collected. Patients will be asked to complete baseline DLQI, SF36, EQ5D, TSQM,WPAI and PBI questionnaires. Photographs of the finger nails will be taken.

Follow-up visits Follow-up assessments will take place at the regularly scheduled outpatient visits at 6 and 12 months (+/- 1 month) after initiation of apremilast.

• Skin-specific disease measures (Psoriasis Activity and Severity Index (PASI), (static) Physician Global Assessment (sPGA), Body Surface Area (BSA))
• Patients will be asked to complete the following questionnaires:
• DLQI
• TSQM
• EQ5D
• SF36- Itch Visual Analog Scale (VAS)
• WPAI Work Productivity and Activity Index
• Patient Benefit Index PBI

End of treatment Upon discontinuation of treatment with apremilast, the date, the dose and reason for discontinuation will be documented.

AE monitoring All patients will be monitored for adverse events throughout the study.

From the time of the patient signing informed consent until treatment with apremilast is permanently abrogated, all non-serious adverse events that are considered related to apremilast and all Serious Adverse Events (SAEs) regardless of causality will be reported.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form.
• Patients starting treatment for psoriasis with apremilast in clinical practice.

Exclusion criteria

• Refusal to participate in the study.
• Women who are pregnant or breast-feeding.
• Hypersensitivity to the active substance or to any of the excipients.
• Prior exposure to apremilast
• Psoriatic arthritis treated by a rheumatologist in the previous year

Trial design

154 participants in 1 patient group

Patients receiving Apremilast per daily clinical practice

Description:

Dutch patients receiving Apremilast according to daily clinical practice