This study aims to evaluate more objectively, through an imaging technique such as ultrasound, changes in joints and entheses of patients with active psoriatic arthritis (PAs) who will start treatment with Apremilast after the failure of other therapies such as synthetic DMARD (metrotrexato , Leflunomide ...). The hypothesis of the study is that the technique of ultrasound can demonstrate the efficacy of Apremilast in the treatment of patients with active PAs
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
30 mg twice a day during 52 weeks. In the first 6 days will be a dose escalation
Reduction in the ultrasound index
Reduction in the ultrasound index at 12 months after the introduction of Apremilast in the study patients
Time frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Disease Activity Score (DAS 28)
Time frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Psoriasis activity and severity index (PASI)
Time frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Leeds Enthesitis Index (LEI)
Time frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Number of tender and swollen joints assessed by (Number of Tender Joints (NTJ) )
Time frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Patient Visual Analog Scale (VAS) for pain
Time frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Ultrasonic nail injuries
Time frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Clinical Disease Activity Index (CDAI)
Time frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Simple Disease Activity Index (SDAI)
Time frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Number of tender and swollen joints assessed by (Number os swollen joints (NSJ))
Time frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
doctor Visual Analog Scale (VAS) for pain
Time frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
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