Study of Apremilast Use in Patients With Psoriatic Arthritic in Practice Conditions

Amgen526 enrolled

Overview

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-

Study Type

OBSERVATIONAL

Enrollment

526

Conditions

Arthritis, Psoriatic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visit 3 compared to baseline on the Physician's Global Assessment scale (PGA; scale from 0-4)

Physician's global assessment (PGA) will be measured on a VAS scale ranging from 0 to 4. Primary endpoint is the percentage of patients with an improvement of minimum 1 point on this VAS scale after about 6 months (visit 3)

Time frame: Up to approximately 7 months

Secondary Outcomes

Percentage of patients with an improvement of ≥ 1 points on the Patient Global Assessment (PaGA) scale on visits 1 to 7 compared to baseline

Patient Global Assessment will be measured on a VAS scale ranging from 0 to 5. The percentage of patients with an improvement of minimum 1 point will be measured throughout the study.