活動性若年性乾癬性関節炎の小児におけるアプレミラストの小児研究 (PEAPOD)
5歳から18歳未満の活動性若年性乾癬性関節炎（PEAPOD）の小児におけるアプレミラストの有効性、安全性、および薬物動態を評価するためのフェーズ3、多施設、二重盲検、無作為化、プラセボ対照、並行群間試験
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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Amgen Call Center
- 電話番号：866-572-6436
- メール：medinfo@amgen.com
研究場所
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Birmingham、イギリス、B4 6NH
- 終了しました
- Birmingham Childrens Hospital
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Liverpool、イギリス、L12 2AP
- 終了しました
- Alder Hey Childrens Hospital
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Nottingham、イギリス、NG7 2UH
- 募集
- Nottingham Childrens Hospital
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Oxford、イギリス、OX3 7LD
- 募集
- John Radcliffe Hospital
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Chieti、イタリア、66100
- 終了しました
- Ospedale Santissima Annunziata
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Genova、イタリア、16147
- 終了しました
- IRCCS Istituto Giannina Gaslini
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Milan、イタリア、20122
- 募集
- Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
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Roma、イタリア、00165
- 終了しました
- IRCCS Ospedale Pediatrico Bambino Gesu
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Utrecht、オランダ、3584 EA
- 募集
- Universitair Medisch Centrum Utrecht
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Athens、ギリシャ、12462
- 終了しました
- Attikon University General Hospital
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Athens、ギリシャ、11527
- 終了しました
- Agia Sofia Children Hospital
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Thessaloniki、ギリシャ、54642
- 募集
- General Hospital of Thessaloniki Ippokrateio
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Madrid、スペイン、28034
- 募集
- Hospital Universitario Ramon y Cajal
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Madrid、スペイン、28046
- 終了しました
- Hospital Universitario La Paz
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Canary Islands
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San Cristóbal de La Laguna、Canary Islands、スペイン、38320
- 募集
- Hospital Universitario de Canarias
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Catalonia
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Barcelona、Catalonia、スペイン、08035
- 募集
- Hospital Universitari Vall d Hebron
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Esplugues de Llobregat、Catalonia、スペイン、08950
- 募集
- Hospital Sant Joan de Deu
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Valencia
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Valencia、Valencia、スペイン、46026
- 募集
- Hospital Universitari i Politecnic La Fe
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Ankara、トルコ（Türkiye）、06100
- 募集
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Istanbul、トルコ（Türkiye）、34098
- 募集
- Istanbul Universitesi Cerrahpasa Tip Fakultesi
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Istanbul、トルコ（Türkiye）、34093
- 募集
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
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Istanbul、トルコ（Türkiye）、34764
- 募集
- Umraniye Egitim ve Arastirma Hastanesi
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Berlin、ドイツ、13353
- 募集
- Charite - Universitaetsmedizin Berlin, Campus Virchow
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Dresden、ドイツ、01307
- 終了しました
- Universitaetsklinikum Dresden
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Hamburg、ドイツ、22081
- 終了しました
- An der Schoen Klinik Hamburg Eilbek
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Sankt Augustin、ドイツ、53757
- 終了しました
- Asklepios Kinderklinik Sankt Augustin GmbH
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Bron、フランス、69677
- 募集
- Hospices Civils de Lyon Hopital Femme Mere Enfant
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Lille、フランス、59037
- 募集
- Hopital Jeanne de Flandre
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Ghent、ベルギー、9000
- 終了しました
- Universitair Ziekenhuis Gent
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Liège、ベルギー、4000
- 終了しました
- Centre Hospitalier Regional de la Citadelle
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Merksem、ベルギー、2170
- 終了しました
- Ziekenhuis Netwerk Antwerpen Jan Palfijn
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Lisbon、ポルトガル、1649-035
- 募集
- Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
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Lisbon、ポルトガル、1349-019
- 終了しました
- Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz
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Ponte de Lima、ポルトガル、4990-041
- 募集
- Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos
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Porto、ポルトガル、4200-319
- 終了しました
- Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
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Vila Nova de Gaia、ポルトガル、4430-502
- 募集
- Unidade Local de Saude de Gaia-Espinho, EPE
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Krakow、ポーランド、31-503
- 終了しました
- Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie
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Lodz、ポーランド、91-738
- 終了しました
- SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
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Warsaw、ポーランド、02-637
- 終了しました
- Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
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Vilnius、リトアニア、08406
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- Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine
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Cluj-Napoca、ルーマニア、400124
- 終了しました
- Spitalul Clinic de Urgenta pentru Copii Cluj
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Timișoara、ルーマニア、300011
- 募集
- Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
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Cape Town、南アフリカ、7935
- 終了しました
- Groote Schuur Hospital
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Western Cape
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Panorama、Western Cape、南アフリカ、7500
- 募集
- Panorama Medical Centre
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
他の名前：
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プラセボコンパレーター：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.
他の名前：
Participants will receive the matching placebo orally. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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16週目の可動範囲が制限された関節数のベースラインからの変化
時間枠：16週目までのベースライン
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16週目までのベースライン
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16週目の炎症の検査マーカー（C反応性タンパク質）のベースラインからの変化
時間枠：16週目までのベースライン
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16週目までのベースライン
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1つ以上の治療に伴う有害事象（TEAE）を経験した参加者の数
時間枠：56週目まで
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56週目まで
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56週目の体重のベースラインからの変化
時間枠：56週目までのベースライン
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56週目までのベースライン
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56週目のベースラインからの身長の変化
時間枠：56週目までのベースライン
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56週目までのベースライン
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56週目のボディマス指数（BMI）のベースラインからの変化
時間枠：56週目までのベースライン
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56週目までのベースライン
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アプレミラストの血漿中濃度
時間枠：2 週目: 投与後 0 ～ 5 時間。 8週目：投与後2時間。 16週目：投与後4時間。 28週目：投与前。 40週目：投与前。 52週目：投与前
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2 週目: 投与後 0 ～ 5 時間。 8週目：投与後2時間。 16週目：投与後4時間。 28週目：投与前。 40週目：投与前。 52週目：投与前
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Change from Baseline in Participants Assessment of Pain at Week 16
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディディレクター：MD、Amgen
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20190529
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD 共有時間枠
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.
IPD 共有アクセス基準
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.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。