Moderate to Severe Plaque Psoriasis
Conditions
Brief summary
Adverse Events: Type, frequency, severity, and relationship to apremilast from Week 0 (Visit 1) through end of Observational Follow-up for the entire study duration, Columbia-Suicide Severity Rating Scale (C-SSRS) Questionnaire to monitor depression, suicidal thoughts and behavior for the entire study duration, Tanner Staging. Assessment of sexual maturity at Week 0 (Visit 1) and then every 52 weeks. Also early termination visit., Body weight, height and BMI: Monitor growth - Height and body weight are measured at each visit
Detailed description
sPGA - Proportion of subjects with an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline
Interventions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events: Type, frequency, severity, and relationship to apremilast from Week 0 (Visit 1) through end of Observational Follow-up for the entire study duration, Columbia-Suicide Severity Rating Scale (C-SSRS) Questionnaire to monitor depression, suicidal thoughts and behavior for the entire study duration, Tanner Staging. Assessment of sexual maturity at Week 0 (Visit 1) and then every 52 weeks. Also early termination visit., Body weight, height and BMI: Monitor growth - Height and body weight are measured at each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| sPGA - Proportion of subjects with an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline | — |
Countries
Belgium, Czechia, Italy, Spain
Outcome results
None listed