Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study) (JUST)
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|ClinicalTrials.gov Identifier: NCT03616561|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : March 18, 2019
|Condition or disease||Intervention/treatment|
|Nail Psoriasis||Drug: Apremilast|
- 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.
- 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|
|Estimated Enrollment :||50 participants|
|Official Title:||Observational Study on Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study)|
|Actual Study Start Date :||February 23, 2018|
|Estimated Primary Completion Date :||May 23, 2019|
|Estimated Study Completion Date :||February 23, 2020|
The cohort will be recruited in Hospital General de Granollers and Hospital Moises Broggi
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 Name: Nail ultrasound
- 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.
- 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.
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616561
|Contact: Carlos Muñoz, PhD||938425000 ext email@example.com|
|Contact: recerca recerca||938425000 ext firstname.lastname@example.org|
|Hospital General de Granollers||Recruiting|
|Granollers, Barcelona, Spain, 08402|
|Contact: recerca recerca 938425000 ext 2973 email@example.com|
|Principal Investigator: Carlos Muñoz Santos, PhD|
|Sub-Investigator: David Vidal Sarro, PhD|
|Principal Investigator:||Carlos Muñoz, PhD||Hospital General de Granollers|