Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study)

Launched by HOSPITAL DE GRANOLLERS · Aug 3, 2018

Keywords

ClinConnect Summary

Primary objective:

- Determine the percentage of patients with at least a 20% improvement over the baseline visit of the NAPPA-PBI scale in weeks 4, 16, 24, 38 and 52.

Secondary objectives:

* Determine the percentage of improvement with respect to the baseline visit of the NAPPA QoL and CLIN scale in weeks 4, 16, 24, 38 and 52
* Determine the percentage of patients, regarding baseline visit, who reach a NAPSI 50 and changes in the NAPSI scale, in weeks 4, 16, 24, 38 and 52
* Determine the percentage of improvement or change of the nail ultrasound variables with respect to the baseline vi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients older than 18 years old at the time of signing the IC
• • Patients with the diagnosis of plaque psoriasis, moderate to severe, at least 6 months before recruitment, with nail involvement and without active psoriatic arthropathy
• • Nail involvement with a minimum NAPSI of 12 for fingernails, and any NAPSI for toenails
• • Patients naïve to biological treatments
• • In pregnant women, pregnancy must be ruled out before treatment can be started and they must use an effective contraceptive method to prevent pregnancy during treatment
• Exclusion Criteria:
• • Other major or clinically uncontrolled diseases
• • Pregnancy or breastfeeding
• • History of allergy to any component of the study medication
• • Positivity for HBV surface antigen at the screening visit
• • Positivity for HCV serology at the screening visit
• • Active tuberculosis or inadequately treated history of tuberculosis
• • Significant abnormalities in electrocardiogram at the screening visit
• • Clinically significant abnormalities of the X-ray chest at the screening visit
• • History of HIV infection or other acquired or congenital immunodeficiencies
• • Active abuse or history of substance abuse 6 months prior to the screening visit
• • Bacterial infection that required oral or injectable antibiotics or important viral or fungal infections within 4 weeks prior to the screening visit
• • Malignancy or history of malignancy (other than cured in situ cutaneous squamous cell carcinoma or basal cell carcinoma, or in situ cérvix carcinoma without evidence of recurrence in the last 5 years)
• • Rebound or relapse of psoriasis in the 4 weeks prior to the screening visit
• • Presence of other cutaneous diseases that could interfere in the clinical assessment of the study
• • Use of topical treatments that include corticosteroids, salicylic acid, urea\> 10% or calcipotriol in the 2 weeks prior to the screening visit
• • Use of systemic treatments for psoriasis, including systemic corticosteroids and PUVA or UVB phototherapy, within 4 weeks prior to the screening visit
• • Previous or current use of biological treatments
• • Use of any investigational drug within 4 weeks prior to the screening visit
• • Previous treatment with apremilast