Arthritis, Psoriatic
Conditions
Keywords
Arthritis, Psoriatic, Observational, Apremilast
Brief summary
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-
Interventions
None listed
Sponsors
Amgen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Up to approximately 7 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to approximately 104 weeks | Additionally to the primary endpoint the improvement of the PGA of minimum 1 point will be measured throughout the study. |
| Efficacy of the treatment with regard to rheumatic changes measured with Tender Joint Count (TJC) on visits 1 to 7 compared to baseline | Up to approximately 104 weeks | Tender Joint Count will be measured throughout the study and compared to baseline. |
| Efficacy of the treatment with regard to rheumatic changes measured with Swollen Joint Count (SJC) on visits 1 to 7 compared to baseline | Up to approximately 104 weeks | Swollen Joint Count will be measured throughout the study and compared to baseline. |
| Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Pain | Up to approximately 104 weeks | Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their pain (0 = no pain, 100 = worst imaginable pain) |
| Psoriatic arthritis Impact of Disease (PsAID) questionnaire on visits 1, 2, 3, 5 and 7 compared to baseline | Up to approximately 104 weeks | Improvement of the Impact of Disease (PsAID) will be measured during visit 1, 2 and 5 and compared to baseline |
| Percentage of patients with an improvement of ≥ 1 points on the Patient Global Assessment (PaGA) scale on visits 1 to 7 compared to baseline | Up to approximately 104 weeks | 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. |
| Hannover Functional Ability Questionnaire (FFbH) on visits 1, 2, 3, 5 and 7 compared to baseline | Up to approximately 104 weeks | Composite score to measure functional improvement will be measured during visits 1, 2 and 5 and compared to baseline |
| Assessment of psoriatic skin changes (Body Surface Area, BSA) on visits 1 to 7 | Up to approximately 104 weeks | Extension of the psoriatic plaques will be measured by body surface area (BSA) throughout the study |
| Adverse Events (AEs) | Up to approximately 104 weeks | Number of subjects with adverse events |
| Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Enthesitis | Up to approximately 104 weeks | Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their enthesitis (0 = no enthesitis, 100 = worst imaginable enthesitis) |
| Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Joints | Up to approximately 104 weeks | 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) |
| Patient Preference Questionnaire (PPQ) on visits 3, 5 and 7 | Up to approximately 104 weeks | The therapy preference of the patient will be measured compared to his previous systemic therapy |
Countries
Germany
Outcome results
None listed