Study of Apremilast Use in Patients With Psoriatic Arthritic in Practice Conditions (LAPIS-PsA)

Amgen

Status: Completed

Conditions: Arthritis, Psoriatic

Study type: Observational

Funder types: Industry

Identifiers

NCT03106051

CC-10004-PSA-008

Details and patient eligibility

About

A total of approximately 500 patients with active psoriatic arthritis in an estimated 80 to 100 trial centers are to be enrolled. Selection of centers will be made by the sponsor's medical section. To increase the quality of the data and to reduce distribution of the data collected, centers to be included will be those which can enroll at least 5 patients. Care will be taken to ensure a balanced regional distribution. The proposed observation period for the trial is approx. 52 weeks per patient. Estimated patient enrolment is also 52 weeks. The duration of the follow-up period will be extended from approx. 52 weeks to approx. 100 weeks to gain further information about the long-term use of Otezla®. For this extension of the follow-up period 2 new visits (visits 6 and 7) are proposed.Thus, proposed duration from first patient in (FPI) to last patient out (LPO) is 36 months-

Enrollment: 526 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The decision to treat with Otezla® has been made independently before inclusion in this study
• Patient age ≥ 18 years
• Existing diagnosis of active psoriatic arthritis
• At least moderately severe psoriatic arthritis (Physician's Global Assessment (PGA) scale ≥ 2)
• Insufficient response or intolerance to previous Disease-Modifying Anti-Rheumatic Drug (DMARD) treatment (disease modifying anti-rheumatic drugs)
• A written informed consent statement by the patient permitting data collection, evaluation, storage and transfer

Exclusion criteria

• Pregnancy
• Hypersensitivity to apremilast or one of the other ingredients in the film tablets
• Other criteria according to the summary of product characteristics Breast-feeding

Trial design

526 participants in 1 patient group

Patients with active psoriatic arthritis

Description:

Patients who suffer from active psoriatic arthritis with at least moderate disease corresponding to a PGA of ≥2