Estudo Pediátrico Apremilast em Crianças com Artrite Psoriática Juvenil Ativa (PEAPOD)
Um estudo de fase 3, multicêntrico, duplo-cego, randomizado, controlado por placebo, de grupo paralelo para avaliar a eficácia, segurança e farmacocinética do Apremilast em crianças de 5 a menos de 18 anos de idade com artrite psoriática juvenil ativa (PEAPOD)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Amgen Call Center
- Número de telefone: 866-572-6436
- E-mail: medinfo@amgen.com
Locais de estudo
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Berlin, Alemanha, 13353
- Recrutamento
- Charite - Universitaetsmedizin Berlin, Campus Virchow
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Dresden, Alemanha, 01307
- Rescindido
- Universitaetsklinikum Dresden
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Hamburg, Alemanha, 22081
- Rescindido
- An der Schoen Klinik Hamburg Eilbek
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Sankt Augustin, Alemanha, 53757
- Rescindido
- Asklepios Kinderklinik Sankt Augustin GmbH
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Ghent, Bélgica, 9000
- Rescindido
- Universitair Ziekenhuis Gent
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Liège, Bélgica, 4000
- Rescindido
- Centre Hospitalier Regional de la Citadelle
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Merksem, Bélgica, 2170
- Rescindido
- Ziekenhuis Netwerk Antwerpen Jan Palfijn
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Madrid, Espanha, 28034
- Recrutamento
- Hospital Universitario Ramon y Cajal
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Madrid, Espanha, 28046
- Rescindido
- Hospital Universitario La Paz
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Canary Islands
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San Cristóbal de La Laguna, Canary Islands, Espanha, 38320
- Recrutamento
- Hospital Universitario de Canarias
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Catalonia
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Barcelona, Catalonia, Espanha, 08035
- Recrutamento
- Hospital Universitari Vall d Hebron
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Esplugues de Llobregat, Catalonia, Espanha, 08950
- Recrutamento
- Hospital Sant Joan de Deu
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Valencia
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Valencia, Valencia, Espanha, 46026
- Recrutamento
- Hospital Universitari i Politecnic La Fe
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Bron, França, 69677
- Recrutamento
- Hospices Civils de Lyon Hopital Femme Mere Enfant
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Lille, França, 59037
- Recrutamento
- Hopital Jeanne de Flandre
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Athens, Grécia, 12462
- Rescindido
- Attikon University General Hospital
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Athens, Grécia, 11527
- Rescindido
- Agia Sofia Children Hospital
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Thessaloniki, Grécia, 54642
- Recrutamento
- General Hospital of Thessaloniki Ippokrateio
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Utrecht, Holanda, 3584 EA
- Recrutamento
- Universitair Medisch Centrum Utrecht
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Chieti, Itália, 66100
- Rescindido
- Ospedale Santissima Annunziata
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Genova, Itália, 16147
- Rescindido
- IRCCS Istituto Giannina Gaslini
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Milan, Itália, 20122
- Recrutamento
- Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
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Roma, Itália, 00165
- Rescindido
- IRCCS Ospedale Pediatrico Bambino Gesu
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Vilnius, Lituânia, 08406
- Recrutamento
- Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine
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Krakow, Polônia, 31-503
- Rescindido
- Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie
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Lodz, Polônia, 91-738
- Rescindido
- SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
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Warsaw, Polônia, 02-637
- Rescindido
- Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
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Lisbon, Portugal, 1649-035
- Recrutamento
- Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
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Lisbon, Portugal, 1349-019
- Rescindido
- Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz
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Ponte de Lima, Portugal, 4990-041
- Recrutamento
- Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos
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Porto, Portugal, 4200-319
- Rescindido
- Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
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Vila Nova de Gaia, Portugal, 4430-502
- Recrutamento
- Unidade Local de Saude de Gaia-Espinho, EPE
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Birmingham, Reino Unido, B4 6NH
- Rescindido
- Birmingham Childrens Hospital
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Liverpool, Reino Unido, L12 2AP
- Rescindido
- Alder Hey Childrens Hospital
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Nottingham, Reino Unido, NG7 2UH
- Recrutamento
- Nottingham Childrens Hospital
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Oxford, Reino Unido, OX3 7LD
- Recrutamento
- John Radcliffe Hospital
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Cluj-Napoca, Romênia, 400124
- Rescindido
- Spitalul Clinic de Urgenta pentru Copii Cluj
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Timișoara, Romênia, 300011
- Recrutamento
- Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
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Ankara, Turquia (Türkiye), 06100
- Recrutamento
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Istanbul, Turquia (Türkiye), 34098
- Recrutamento
- Istanbul Universitesi Cerrahpasa Tip Fakultesi
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Istanbul, Turquia (Türkiye), 34093
- Recrutamento
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
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Istanbul, Turquia (Türkiye), 34764
- Recrutamento
- Umraniye Egitim ve Arastirma Hastanesi
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Cape Town, África do Sul, 7935
- Rescindido
- Groote Schuur Hospital
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Western Cape
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Panorama, Western Cape, África do Sul, 7500
- Recrutamento
- Panorama Medical Centre
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Male or Female participants 5 to < 18 years of age at the time of randomization.
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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
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Active disease: at least 3 active joints.
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Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate [MTX] or biologic agents).
Exclusion Criteria:
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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).
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Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.
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Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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. |
Participants will receive apremilast orally.
Outros nomes:
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Comparador de Placebo: 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. |
Participants will receive apremilast orally.
Outros nomes:
Participants will receive the matching placebo orally. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16
Prazo: Baseline to Week 16
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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:
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Baseline to Week 16
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Alteração da linha de base no número de articulações com amplitude de movimento limitada na semana 16
Prazo: Linha de base até a semana 16
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Linha de base até a semana 16
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Alteração da linha de base no marcador laboratorial de inflamação (proteína C reativa) na semana 16
Prazo: Linha de base até a semana 16
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Linha de base até a semana 16
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Número de participantes que experimentaram um ou mais eventos adversos emergentes do tratamento (TEAEs)
Prazo: Até a semana 56
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Até a semana 56
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Mudança da linha de base no peso corporal na semana 56
Prazo: Linha de base até a semana 56
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Linha de base até a semana 56
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Mudança da linha de base em altura na semana 56
Prazo: Linha de base até a semana 56
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Linha de base até a semana 56
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Mudança da linha de base no Índice de Massa Corporal (IMC) na Semana 56
Prazo: Linha de base até a semana 56
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Linha de base até a semana 56
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Concentrações plasmáticas de Apremilast
Prazo: Semana 2: 0-5 horas após a dose; Semana 8: 2 horas após a dose; Semana 16: 4 horas após a dose; Semana 28: pré-dose; Semana 40: pré-dose; Semana 52: pré-dose
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Semana 2: 0-5 horas após a dose; Semana 8: 2 horas após a dose; Semana 16: 4 horas após a dose; Semana 28: pré-dose; Semana 40: pré-dose; Semana 52: pré-dose
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Change from Baseline in Participants Assessment of Pain at Week 16
Prazo: Baseline to Week 16
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The participants assessment of pain will be assessed using a visual analogue scale (VAS). Participants will be asked to place a vertical line on a 100-mm VAS where the left-hand boundary represents "no pain" and the right-hand boundary represents "worst possible pain". |
Baseline to Week 16
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Number of Participants who Achieve ACR Pedi 20, ACR Pedi 50, ACR Pedi 70 and ACR Pedi 90 Response at Week 16
Prazo: Baseline to Week 16
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The ACR Pedi 20, 50, 70 and 90 is defined as a minimum of either 20 percent, 50 percent. 70 percent or 90 percent improvement respectively from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >20 percent, >50 percent, >70 percent or >90 percent respectively. The ACR Pedi consists of 6 core criteria:
6. laboratory marker of inflammation (CRP). |
Baseline to Week 16
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Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at Week 16
Prazo: Baseline to Week 16
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PGA of disease activity is assessed using a visual analog scale (VAS), where 0 represents no disease activity and 100 represents the most disease activity. |
Baseline to Week 16
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Change from Baseline in the Assessment of Overall Well-being at Week 16
Prazo: Baseline to Week 16
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Assessment of overall well-being is assessed using a visual analog scale (VAS), where 0 represents very well and 100 represents very poor for overall well-being. This assessment can be completed by either the participant or the parent/caregiver. |
Baseline to Week 16
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Change from Baseline in the Number of Joints with Active Arthritis at Week 16
Prazo: Baseline to Week 16
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Active arthritis is defined as joints with swelling not caused by deformity of joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both. |
Baseline to Week 16
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Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 16
Prazo: Baseline to Week 16
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The CHAQ will be used to assess physical ability and functional status of participants as well as their quality of life. The CHAQ consists of 20 items concerning difficulty in performing the following 8 activities of daily living: dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping, and activities. Subjects will choose from 4 responses ranging from 0 (without any difficulty) to 3 (unable to do). A lower score indicates a better outcome. The subject's/parent's/caregiver's assessment of arthritis-related pain will also be assessed on a VAS that is part of the CHAQ. |
Baseline to Week 16
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Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Week 16
Prazo: Baseline to Week 16
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JADAS is a composite score of participant well-being visual analog scale (VAS) score, physician global assessment (PGA) VAS score, active joint count, and laboratory marker of inflammation (C-reactive protein [CRP]). There are 4 components of the JADAS:
The active joint count is taken from 71 joints: Temporomandibular joints, cervical spine, glenohumeral joints, acromioclavicular joints, sternoclavicular joints, elbows, wrists, metacarpophalangeal joints, interphalangeal joints, proximal interphalangeal joints, distal interphalangeal joints, hips, subtalar joints, midfoot joints, knees and ankles . The total score is calculated by adding all 4 components of the JADAS. The score for the JADAS ranges from 0 to 101 where a lower score indicates a better outcome. |
Baseline to Week 16
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Number of Participants who Experience Psoriatic Arthritis (PsA) Flares at Week 16
Prazo: Baseline to Week 16
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PsA flares are defined as more than or equal to 30 percent worsening in at least 3 of 6 American College of Rheumatology Pediatric (ACR Pedi) core set variables with a more than or equal to 30 percent improvement in not more than 1 of 6 ACR Pedi core set variables. |
Baseline to Week 16
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Psoriasis Area Severity Index (PASI)-75 Response at Week 16 for Participants With a Baseline Psoriasis Body Surface Area (BSA) ≥ 3 percent
Prazo: Baseline to Week 16
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PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The PASI score is determined only for subjects whose BSA involved by psoriasis is ≥3 percent. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on the 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90 percent < 100 percent involvement). The sum of scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percentage of BSA. The resultant values for each anatomic region are then summed to yield the PASI score. |
Baseline to Week 16
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Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS)
Prazo: Up to Week 56
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The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior is defined as the number of participants who answer "yes" at any time during the study (up to end of safety follow-up, Week 56) to one of the 10 categories: Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide |
Up to Week 56
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Change from Baseline in Tanner Staging at Week 52
Prazo: Baseline to Week 52
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Tanner Staging of sexual development assessment will be used to assess sexual maturity. Tanner Staging assessment consists of 3 domains (pubic hair, breast development, and other changes) for girls and 4 domains (pubic hair, penis development, testes development, and other changes) for boys. Stages range from 1-5, with 1 indicating preadolescent and 5 adult. |
Baseline to Week 52
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Taste and Acceptability of Apremilast
Prazo: Baseline and Week 2
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Taste and acceptability will be assessed using a questionnaire with a 7-point faces Likert Scale, with 1 ranging from "super bad" to 7 "super good" and questions to determine whether the participants are able to take the treatment medication. |
Baseline and Week 2
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: MD, Amgen
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20190529
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Prazo de Compartilhamento de IPD
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Critérios de acesso de compartilhamento IPD
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
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