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

Study Overview
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Brief Summary
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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-

Official Title
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Long-term Documentation on the Use of Apremilast in Patients With Psoriatic Arthritis in Practice Conditions

Conditions
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Arthritis, Psoriatic

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with active psoriatic arthritis<br>Patients who suffer from active psoriatic arthritis with at least moderate disease corresponding to a PGA of ≥2 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Up to approximately 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Additionally to the primary endpoint the improvement of the PGA of minimum 1 point will be measured throughout the study. | 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 | Tender Joint Count will be measured throughout the study and compared to baseline. | 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 | Swollen Joint Count will be measured throughout the study and compared to baseline. | 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 | Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their pain (0 = no pain, 100 = worst imaginable pain) | Up to approximately 104 weeks | 
| Psoriatic arthritis Impact of Disease (PsAID) questionnaire on visits 1, 2, 3, 5 and 7 compared to baseline | Improvement of the Impact of Disease (PsAID) will be measured during visit 1, 2 and 5 and compared to baseline | Up to approximately 104 weeks | 
| Hannover Functional Ability Questionnaire (FFbH) on visits 1, 2, 3, 5 and 7 compared to baseline | Composite score to measure functional improvement will be measured during visits 1, 2 and 5 and compared to baseline | Up to approximately 104 weeks | 
| Patient Preference Questionnaire (PPQ) on visits 3, 5 and 7 | The therapy preference of the patient will be measured compared to his previous systemic therapy | Up to approximately 104 weeks | 
| Assessment of psoriatic skin changes (Body Surface Area, BSA) on visits 1 to 7 | Extension of the psoriatic plaques will be measured by body surface area (BSA) throughout the study | Up to approximately 104 weeks | 
| Adverse Events (AEs) | Number of subjects with adverse events | 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 | Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their enthesitis (0 = no enthesitis, 100 = worst imaginable enthesitis) | 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 | Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their joints (0 = no affected joints, 100 = heavily affected joints) | Up to approximately 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, Psoriatic, Observational, Apremilast