Study of apremilast use in patients with psoriatic arthritic in practice conditionsLAPIS-PsA
Study Details
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-
Protocol Summary
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)
Timeframe: Up to approximately 7 months
Percentage of patients with an improvement of ≥ 1 points on the Patient Global Assessment (PaGA) scale on visits 1 to 7 compared to baseline
Timeframe: Up to approximately 104 weeks
Percentage of patients with an improvement of ≥ 1 points on the Physician’s Global Assessment (PGA) scale on visits 1, 2, 4, 5, 6, 7 compared to baseline
Timeframe: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Tender Joint Count (TJC) on visits 1 to 7 compared to baseline
Timeframe: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Swollen Joint Count (SJC) on visits 1 to 7 compared to baseline
Timeframe: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Pain
Timeframe: Up to approximately 104 weeks
Psoriatic arthritis Impact of Disease (PsAID) questionnaire on visits 1, 2, 3, 5 and 7 compared to baseline
Timeframe: Up to approximately 104 weeks
Hannover Functional Ability Questionnaire (FFbH) on visits 1, 2, 3, 5 and 7 compared to baseline
Timeframe: Up to approximately 104 weeks
Patient Preference Questionnaire (PPQ) on visits 3, 5 and 7
Timeframe: Up to approximately 104 weeks
Assessment of psoriatic skin changes (Body Surface Area, BSA) on visits 1 to 7
Timeframe: Up to approximately 104 weeks
Adverse Events (AEs)
Timeframe: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Enthesitis
Timeframe: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Joints
Timeframe: Up to approximately 104 weeks