Apremilast Pediatric Study in Children with Active Juvenile Psoriatic ArthritisPEAPOD
Study Details
The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.
Protocol Summary
Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16
Timeframe: Baseline to Week 16
Change from Baseline in Participants Assessment of Pain at Week 16
Timeframe: Baseline to Week 16
Number of Participants who Achieve ACR Pedi 20, ACR Pedi 50, ACR Pedi 70 and ACR Pedi 90 Response at Week 16
Timeframe: Baseline to Week 16
Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at Week 16
Timeframe: Baseline to Week 16
Change from Baseline in the Assessment of Overall Well-being at Week 16
Timeframe: Baseline to Week 16
Change from Baseline in the Number of Joints with Active Arthritis at Week 16
Timeframe: Baseline to Week 16
Change from Baseline in the Number of Joints with Limited Range of Motion at Week 16
Timeframe: Baseline to Week 16
Change from Baseline in the Laboratory Marker of Inflammation (C-reactive Protein) at Week 16
Timeframe: Baseline to Week 16
Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 16
Timeframe: Baseline to Week 16
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Week 16
Timeframe: Baseline to Week 16
Number of Participants who Experience Psoriatic Arthritis (PsA) Flares at Week 16
Timeframe: Baseline to Week 16
Psoriasis Area Severity Index (PASI)-75 Response at Week 16 for Participants With a Baseline Psoriasis Body Surface Area (BSA) ≥ 3 percent
Timeframe: Baseline to Week 16
Number of Participants who Experience One or More Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to Week 56
Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS)
Timeframe: Up to Week 56
Change from Baseline in Tanner Staging at Week 52
Timeframe: Baseline to Week 52
Change from Baseline in Body Weight at Week 56
Timeframe: Baseline to Week 56
Change from Baseline in Height at Week 56
Timeframe: Baseline to Week 56
Change from Baseline in Body Mass Index (BMI) at Week 56
Timeframe: Baseline to Week 56
Plasma Concentrations of Apremilast
Timeframe: Week 2: 0-5 hours post dose; Week 8: 2 hours post dose; Week 16: 4 hours post-dose; Week 28: pre dose; Week 40: pre dose; Week 52: pre dose
Taste and Acceptability of Apremilast
Timeframe: Baseline and Week 2