Nail PsoriasisJUSTNCT03616561
Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study)
An observational study of Nail Psoriasis, run by Hospital de Granollers at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Psoriasis
- What is being tested?
- Apremilast
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 23 Feb 2018to 23 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Apremilast
- Keywords
- Nail psoriasis, apremilast, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called Nail ultrasound
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.
| Study group | Role | What they receive |
|---|---|---|
| Apremilast | The cohort will be recruited in Hospital General de Granollers and Hospital Moises Broggi Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: first visit and week 4, 16, 24, 38 and 52
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: baseline (first visit) and week 4, 16, 24, 38 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start23 Feb 2018
- Primary completion23 May 2020
- Study completion23 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Sant Joan Despí Moisès Broggi
- Responsible party
- Sponsor
- Investigators
- Carlos Muñoz, PhD, Principal investigator, Hospital General de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616561
- Sponsor's protocol ID
- 20172005
- Acronym
- JUST
- Status last verified
- Jul 2020
- First submitted
- 12 Apr 2018
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study)
- ClinicalTrials.gov ID
- NCT03616561
- Acronym / sponsor ID
- JUST / 20172005
- Conditions
- Nail Psoriasis
- Keywords
- Nail psoriasis, apremilast, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Collaborators
- Hospital de Sant Joan Despí Moisès Broggi
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 23 May 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apremilast | – | Drug: ApremilastThe cohort will be recruited in Hospital General de Granollers and Hospital Moises Broggi |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastAlso: Nail ultrasoundTarget 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. | Drug | Apremilast |
Primary outcome
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.
4 secondary outcomes
Nail ultrasound: changes in nail plate, bed and matrix thickness
Time frame: 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
Questionnaire: NAPPA- Clinical changes
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Muñoz, PhD principal investigator
Hospital General de Granollers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nail Psoriasis, run by Hospital de Granollers at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire: NAPPA- PBI changes (time frame: first visit and week 4, 16, 24, 38 and 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.