A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)
概览
- 阶段
- 3 期
- 干预措施
- Placebo
- 疾病 / 适应症
- Active Juvenile Psoriatic Arthritis
- 发起方
- Amgen
- 入组人数
- 60
- 试验地点
- 87
- 主要终点
- Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16
- 状态
- 招募中
- 最后更新
- 12天前
概览
简要总结
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.
研究者
入排标准
入选标准
- •Male or Female participants 5 to \< 18 years of age at the time of randomization.
- •Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration:
- •Arthritis and psoriasis, OR
- •Arthritis with at least 2 of the following:
- •Dactylitis
- •Nail pitting or onycholysis
- •Psoriasis in a first-degree relative
- •Active disease: at least 3 active joints.
- •Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate \[MTX\] or biologic agents).
排除标准
- •Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:
- •Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
- •Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
- •History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
- •Presence of systemic juvenile idiopathic arthritis (JIA).
- •Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.
- •Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
研究组 & 干预措施
Placebo to Apremilast
Participants will receive the matching placebo in the double-blind 16 week treatment phase. Then the participants will receive apremilast in the active 36 weeks treatment phase.
干预措施: Placebo
Apremilast
Participants will receive apremilast in the double-blind 16 week treatment phase. Then the participants will continue to receive apremilast in the active 36 weeks treatment phase.
干预措施: Apremilast
Placebo to Apremilast
Participants will receive the matching placebo in the double-blind 16 week treatment phase. Then the participants will receive apremilast in the active 36 weeks treatment phase.
干预措施: Apremilast
结局指标
主要结局
Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16
时间窗: Baseline to Week 16
The ACR Pedi 30 is defined as a minimum of 30 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by \>30 percent. The ACR Pedi consists of 6 core criteria: 1. physician global assessment (PGA) of disease activity (visual analog scale \[VAS\]) where 0 represents no disease activity and 100 represents the most disease activity 2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being 3. functional ability (assessed using the Childhood Health Assessment Questionnaire \[CHAQ\]); 4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) 5. number of joints with limited range of motion 6. laboratory marker of inflammation (C-reactive protein \[CRP\]).
次要结局
- Change from Baseline in the Laboratory Marker of Inflammation (C-reactive Protein) at Week 16(Baseline to Week 16)
- Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Week 16(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(Baseline to Week 16)
- Number of Participants who Experience One or More Treatment-Emergent Adverse Events (TEAEs)(Up to Week 56)
- Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS)(Up to Week 56)
- Change from Baseline in Tanner Staging at Week 52(Baseline to Week 52)
- Change from Baseline in Body Weight at Week 56(Baseline to Week 56)
- Change from Baseline in Height at Week 56(Baseline to Week 56)
- Change from Baseline in Body Mass Index (BMI) at Week 56(Baseline to Week 56)
- Plasma Concentrations of Apremilast(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(Baseline and Week 2)
- Change from Baseline in Body Weight at Week 56(Baseline to Week 56)
- Change from Baseline in Height at Week 56(Baseline to Week 56)
- Change from Baseline in Body Mass Index (BMI) at Week 56(Baseline to Week 56)
- Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at Week 16(Baseline to Week 16)
- Change from Baseline in Participants Assessment of Pain at Week 16(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(Baseline to Week 16)
- Change from Baseline in the Assessment of Overall Well-being at Week 16(Baseline to Week 16)
- Change from Baseline in the Number of Joints with Active Arthritis at Week 16(Baseline to Week 16)
- Change from Baseline in the Number of Joints with Limited Range of Motion at Week 16(Baseline to Week 16)
- Change from Baseline in the Laboratory Marker of Inflammation (C-reactive Protein) at Week 16(Baseline to Week 16)
- Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 16(Baseline to Week 16)
- Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Week 16(Baseline to Week 16)
- Number of Participants who Experience Psoriatic Arthritis (PsA) Flares at Week 16(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(Baseline to Week 16)
- Number of Participants who Experience One or More Treatment-Emergent Adverse Events (TEAEs)(Up to Week 56)
- Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS)(Up to Week 56)
- Change from Baseline in Tanner Staging at Week 52(Baseline to Week 52)
- Plasma Concentrations of Apremilast(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(Baseline and Week 2)