활동성 소아 건선성 관절염이 있는 소아에 대한 아프레밀라스트 소아 연구 (PEAPOD)
5세부터 18세 미만의 활동성 소아 건선성 관절염(PEAPOD)을 앓고 있는 소아에서 아프레밀라스트의 효능, 안전성 및 약동학을 평가하기 위한 3상, 다기관, 이중 맹검, 무작위, 위약 대조, 병렬 그룹 연구
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Amgen Call Center
- 전화번호: 866-572-6436
- 이메일: medinfo@amgen.com
연구 장소
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Athens, 그리스, 12462
- 종료됨
- Attikon University General Hospital
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Athens, 그리스, 11527
- 종료됨
- Agia Sofia Children Hospital
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Thessaloniki, 그리스, 54642
- 모병
- General Hospital of Thessaloniki Ippokrateio
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Cape Town, 남아프리카, 7935
- 종료됨
- Groote Schuur Hospital
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Western Cape
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Panorama, Western Cape, 남아프리카, 7500
- 모병
- Panorama Medical Centre
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Utrecht, 네덜란드, 3584 EA
- 모병
- Universitair Medisch Centrum Utrecht
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Berlin, 독일, 13353
- 모병
- Charite - Universitaetsmedizin Berlin, Campus Virchow
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Dresden, 독일, 01307
- 종료됨
- Universitaetsklinikum Dresden
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Hamburg, 독일, 22081
- 종료됨
- An der Schoen Klinik Hamburg Eilbek
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Sankt Augustin, 독일, 53757
- 종료됨
- Asklepios Kinderklinik Sankt Augustin GmbH
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Cluj-Napoca, 루마니아, 400124
- 종료됨
- Spitalul Clinic de Urgenta pentru Copii Cluj
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Timișoara, 루마니아, 300011
- 모병
- Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
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Vilnius, 리투아니아, 08406
- 모병
- Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine
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Ghent, 벨기에, 9000
- 종료됨
- Universitair Ziekenhuis Gent
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Liège, 벨기에, 4000
- 종료됨
- Centre Hospitalier Regional de la Citadelle
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Merksem, 벨기에, 2170
- 종료됨
- Ziekenhuis Netwerk Antwerpen Jan Palfijn
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Madrid, 스페인, 28034
- 모병
- Hospital Universitario Ramon y Cajal
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Madrid, 스페인, 28046
- 종료됨
- Hospital Universitario La Paz
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Canary Islands
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San Cristóbal de La Laguna, Canary Islands, 스페인, 38320
- 모병
- Hospital Universitario de Canarias
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Catalonia
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Barcelona, Catalonia, 스페인, 08035
- 모병
- Hospital Universitari Vall d Hebron
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Esplugues de Llobregat, Catalonia, 스페인, 08950
- 모병
- Hospital Sant Joan de Deu
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Valencia
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Valencia, Valencia, 스페인, 46026
- 모병
- Hospital Universitari i Politecnic La Fe
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Birmingham, 영국, B4 6NH
- 종료됨
- Birmingham Childrens Hospital
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Liverpool, 영국, L12 2AP
- 종료됨
- Alder Hey Childrens Hospital
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Nottingham, 영국, NG7 2UH
- 모병
- Nottingham Childrens Hospital
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Oxford, 영국, OX3 7LD
- 모병
- John Radcliffe Hospital
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Chieti, 이탈리아, 66100
- 종료됨
- Ospedale Santissima Annunziata
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Genova, 이탈리아, 16147
- 종료됨
- IRCCS Istituto Giannina Gaslini
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Milan, 이탈리아, 20122
- 모병
- Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
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Roma, 이탈리아, 00165
- 종료됨
- IRCCS Ospedale Pediatrico Bambino Gesu
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Ankara, 터키 (Türkiye), 06100
- 모병
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Istanbul, 터키 (Türkiye), 34098
- 모병
- Istanbul Universitesi Cerrahpasa Tip Fakultesi
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Istanbul, 터키 (Türkiye), 34093
- 모병
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
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Istanbul, 터키 (Türkiye), 34764
- 모병
- Umraniye Egitim ve Arastirma Hastanesi
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Lisbon, 포르투갈, 1649-035
- 모병
- Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
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Lisbon, 포르투갈, 1349-019
- 종료됨
- Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz
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Ponte de Lima, 포르투갈, 4990-041
- 모병
- Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos
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Porto, 포르투갈, 4200-319
- 종료됨
- Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
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Vila Nova de Gaia, 포르투갈, 4430-502
- 모병
- Unidade Local de Saude de Gaia-Espinho, EPE
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Krakow, 폴란드, 31-503
- 종료됨
- Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie
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Lodz, 폴란드, 91-738
- 종료됨
- SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
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Warsaw, 폴란드, 02-637
- 종료됨
- Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
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Bron, 프랑스, 69677
- 모병
- Hospices Civils de Lyon Hopital Femme Mere Enfant
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Lille, 프랑스, 59037
- 모병
- Hopital Jeanne de Flandre
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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.
다른 이름들:
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위약 비교기: 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.
다른 이름들:
Participants will receive the matching placebo orally. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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16주차에 가동 범위가 제한된 관절 수의 기준선에서 변경
기간: 16주까지의 기준선
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16주까지의 기준선
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16주에 실험실 염증 마커(C-반응성 단백질)의 기준선에서 변경
기간: 16주까지의 기준선
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16주까지의 기준선
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하나 이상의 치료 관련 부작용(TEAE)을 경험한 참가자 수
기간: 56주까지
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56주까지
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56주차 기준 체중의 변화
기간: 56주까지의 기준선
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56주까지의 기준선
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56주차 기준선에서 키의 변화
기간: 56주까지의 기준선
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56주까지의 기준선
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56주에 체질량 지수(BMI)의 기준선에서 변경
기간: 56주까지의 기준선
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56주까지의 기준선
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아프레밀라스트의 혈장 농도
기간: 2주차: 투여 후 0-5시간; 8주차: 투약 후 2시간; 16주차: 투약 후 4시간; 28주차: 투약 전; 40주차: 투약 전; 52주차: 투여 전
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2주차: 투여 후 0-5시간; 8주차: 투약 후 2시간; 16주차: 투약 후 4시간; 28주차: 투약 전; 40주차: 투약 전; 52주차: 투여 전
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Change from Baseline in Participants Assessment of Pain at Week 16
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: Up to Week 56
|
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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: MD, Amgen
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 20190529
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .