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

NCT03616561 | Completed DMC

• 1 other identifier: 20172005
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nail Psoriasis

Keywords

Nail psoriasis; apremilast; ultrasound

Outcome Measures

Primary Outcomes (1)

• Questionnaire: NAPPA- PBI changes

  Nail assessment in psoriasis and psoriatic arthritis (NAPPA) is a modular instrument for the assessment of clinical and patient-reported outcomes in nail psoriasis. NAPPA comprises three components: NAPPA-QOL measuring nail-specific quality of life, NAPPA-PBI reflecting patient-relevant needs and treatment benefits, NAPPA-CLIN recording objective nail status. NAPPA-PBI questionnaire is a 24-item questionnaire which assesses patient-defined needs before and patient-rated benefits after treatment. The answers are given in Likert scales from 0 to 4, and a global score is calculated based on the importance-weighted benefit items. The principle of PBI is an advanced mode of goal attainment scaling with standardized goal items. range from 0 to 96. Higher values represent a better outcome.

  first visit and week 4, 16, 24, 38 and 52

Secondary Outcomes (4)

• Nail ultrasound: changes in nail plate, bed and matrix thickness

  baseline (first visit) and week 4, 16, 24, 38 and 52

• Questionnaire: NAPPA-QoL changes

  baseline (first visit) and week 4, 16, 24,38 and 52

• Questionnaire: NAPPA- Clinical changes

  baseline (first visit) and week 4, 16, 24, 38 and 52

• fingernail and toenail NAPSI score changes

  baseline (first visit) and week 4, 16, 24, 38 and 52

Study Arms (1)

Apremilast

The cohort will be recruited in Hospital General de Granollers and Hospital Moises Broggi

Drug: Apremilast

Interventions

Apremilast DRUG

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.

Also known as: Nail ultrasound

Apremilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with moderate to severe psoriasis vulgaris and nail involvement and are candidates for treatment with apremilast according to the product's summary of characteristics Moderate-severe psoriasis will be considered according to the consensus document of the Spanish group of psoriasis from the Spanish Academy of Dermatology and Venereology (AEDV, 2009)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Granollers: lead
• Hospital de Sant Joan Despí Moisès Broggi: collaborator

Study Sites (1)

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

MeSH Terms

Interventions

apremilast

Study Officials

• Carlos Muñoz, PhD

  Hospital General de Granollers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: August 6, 2018
• Study Start: February 23, 2018
• Primary Completion: May 23, 2020
• Study Completion: July 23, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

ES (1)