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

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

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.

Study Overview

• Status: Completed
• Conditions: Nail Psoriasis
• Intervention / Treatment: Drug: Apremilast

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

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Granollers, Barcelona, Spain, 08402
      • Hospital General de Granollers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.; Other Names: Nail ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nail ultrasound: changes in nail plate, bed and matrix thickness	change in nail ultrasound measures nail plate, bed and matrix thickness. Data will be displayed in millimeters. Higher values represent a worse outcome.	baseline (first visit) and week 4, 16, 24, 38 and 52
Questionnaire: NAPPA-QoL changes	NAPPA-QOL questionnaire is a 20-item nail specific quality of life questionnaire which assesses specific quality of life conditions in the past week. Answers are given in Likert scales from 0 to 4. Factor analysis revealed three scales named 'Signs' (nail status), 'Stigma' (nail impact: stigma and emotional status), and 'Everyday life' (nail impact: everyday life). For use in clinical trials, a global score including all items without weighting is used and mean values are determined. range from 0 to 80. Higher values represent a worse outcome	baseline (first visit) and week 4, 16, 24,38 and 52
Questionnaire: NAPPA- Clinical changes	NAPPA-CLIN score is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands, or both feet, respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16 respectively. Higher values represent a worse outcome	baseline (first visit) and week 4, 16, 24, 38 and 52
fingernail and toenail NAPSI score changes	Nail psoriasis severity index (NAPSI) is a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 8 criteria for each nail (0-8 point scale for every nail) .The NAPSI score will be determined using all 10 fingernails and toenails, on a 0-80 point scale (respectively). Higher values represent a worse outcome	baseline (first visit) and week 4, 16, 24, 38 and 52

Collaborators and Investigators

• Sponsor: Hospital de Granollers
• Collaborators: Hospital de Sant Joan Despí Moisès Broggi
• Investigators: Principal Investigator: Carlos Muñoz, PhD, Hospital General de Granollers

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2018
• Primary Completion (Actual): May 23, 2020
• Study Completion (Actual): July 23, 2020

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: ultrasound; apremilast; Nail psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: 20172005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No