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

July 28, 2020 updated by: Hospital de Granollers

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Questionnaire: NAPPA- PBI changes
Time Frame: first visit and week 4, 16, 24, 38 and 52
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nail ultrasound: changes in nail plate, bed and matrix thickness
Time Frame: baseline (first visit) and week 4, 16, 24, 38 and 52
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
Time Frame: baseline (first visit) and week 4, 16, 24,38 and 52
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
Time Frame: baseline (first visit) and week 4, 16, 24, 38 and 52
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
Time Frame: baseline (first visit) and week 4, 16, 24, 38 and 52
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Granollers

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital de Sant Joan Despí Moisès Broggi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carlos Muñoz, PhD, Hospital General de Granollers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 23, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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