NCT03616561

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Hospital de Granollers · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Prospective open label non-randomized study, using Apremilast according to the manufacturer's Summary of Product Characteristics for 52 weeks, in patients with moderate to severe plaque psoriasis and nail psoriasis The study will be carried out in two hospital centers with experience in the management of patients with psoriasis and in the use of ultrasound of the nail apparatus. Visits and ultrasound would be performed by prescribing doctors themselves in their outpatient offices. Prior to the start of the study, the two doctors of each center will conduct a study to see the intraobserver and interobserver agreement on the ecographic parameters. The medication would be dispensed and controlled in the centers themselves and self-administered by patients at home. Each visit includes a ultrasound assessment of a target nail and measures of different scales: NAPSI, NAPPA.

Detailed description

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 visit in weeks 4, 16, 24, 38 and 52 * Explore the possible correlation between clinical (NAPSI / NAPPA-Clin) and ultrasound variables before and after treatment * Determine the percentage of patients with sonographic signs of enthesopathy of the distal interphalangeal joint before and after treatment * Determine differences in clinical and sonographic parameters before treatment in good responders (NAPSI 50) compared to non-responders

Conditions

• Nail Psoriasis

Interventions

Type	Name	Description
DRUG	Apremilast	Target nail ultrasound will be performed in patients on apremilast by two expert dermatologists and each one will determine the ecographic parameters described in the protocol. These variables would be measured in one target nail in each patient, the greatest and most severely affected, at the investigator's criterion. The same nail will be assessed in all visits of the study (baseline, weeks 4, 16, 24, 38 and 52) . The ultrasound study will be performed with the same device in both hospitals: Esaote's MyLab ultrasound with a 20 MHz transducer. Prior to the start of the study the investigators evaluated the ultrasonographic inter-intraobserver concordance.

Timeline

• Start date: 2018-02-23
• Primary completion: 2020-05-23
• Completion: 2020-07-23
• First posted: 2018-08-06
• Last updated: 2020-07-29

Locations

1 site across 1 country: Spain