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治験 NCT05609630 (SELECT-sJIA)（対象：若年性特発性関節炎）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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アッヴィStudy of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis. (SELECT-sJIA) 第III相・フェーズ3 90 小児 思春期
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治験番号 NCT05609630 (SELECT-sJIA) は 若年性特発性関節炎 に関する 治療 の研究で、第III相・フェーズ3 介入研究 臨床試験 です。現在は 募集中 で、2023年10月2日 から開始しています。90 名の参加者 の募集が計画されています。この試験は アッヴィ によって主導され、2029年6月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月10日 です。
概要
Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis that affects children. The term "idiopathic" means "of unknown origin". It is a chronic (long-lasting) disease that causes swelling, warmth, and pain of one or more small joints. Systemic JIA ia a rare and serious form of JIA. Systemic" means it may affect not only the joints but other parts of the body, including the liver, lungs and heart. sJI...もっと見る
公式タイトル
A Multicenter, Randomized Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Upadacitinib With a Tocilizumab Reference Arm in Subjects From 1 Year to Less Than 18 Years Old With Active Systemic Juvenile Idiopathic Arthritis
疾患名
若年性特発性関節炎その他の研究識別子
- SELECT-sJIA
- M14-682
- 2022-501599-25-00 (その他の識別子) (EU CT)
NCT番号
開始日
2023-10-02
最終更新日
2026-02-10
終了予定日
2029-06
目標参加者数
90
試験の種類
介入研究
治験の相・段階
第III相・フェーズ3
状況
募集中
キーワード
Systemic Juvenile Idiopathic Arthritis
sJIA
Upadacitinib
ABT-494
sJIA
Upadacitinib
ABT-494
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Cohort 1 Upadacitinib Participants will receive upadacitinib for 52 weeks. | ウパダシチニブ Oral tablet or Oral solution |
実薬対照薬Cohort 1 Tocilizumab Participants will receive tocilizumab for 52 weeks. | Tocilizumab Subcutaneous injection or Intravenous infusion |
実験的Cohort 2 Upadacitinib Participants will receive upadacitinib for 52 weeks. | ウパダシチニブ Oral tablet or Oral solution |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response | ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 30 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of ≥ 30% of the 6 variables of the JIA core set with no more than 1 variable worsening by \> 30%. | At Week 12 |
Number of Participants with Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to Approximately Week 52 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 50 Response | ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 50 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of ≥ 50% of the 6 variables of the JIA core set. | Week 12 |
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 70 Response | ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 70 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of ≥ 70% of the 6 variables of the JIA core set. | Week 12 |
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 90 Response | ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 90 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of ≥ 90% of the 6 variables of the JIA core set. | Week 12 |
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 100 Response | ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACR 100 Response is defined as absence of fever \[\> 38°C\] in the previous 1 week preceding evaluation and improvement of ≥ 100% of the 6 variables of the JIA core set. | Week 12 |
Change from Baseline in Number of Joints with Active Arthritis | Change from Baseline in Number of Joints with Active Arthritis | Week 12 |
Change from Baseline in Number of Joints with Limitation of Motion | Change from Baseline in Number of Joints with Limitation of Motion | Week 12 |
Change from Baseline in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) | The CHAQ-DI consists of 30 items and assesses function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 5 response options ranging from no difficulty to unable to do, scored 0 to 3, and not applicable. | Week 12 |
Change From Baseline in Patient's Global Assessment (PtGA) | Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline. | Week 12 |
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA) | Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline. | Week 12 |
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | High sensitivity C-reactive protein was analyzed by a central laboratory. The median percent change from baseline in CRP is assessed at each time point. | Week 12 |
Percentage of Participants with Absence of fever (> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA) | Absence of fever (\> 38°C) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA) | Week 12 |
Change from Baseline in Glucocorticoid Dose | Change from Baseline in Glucocorticoid Dose | Week 12 |
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP) | Juvenile Arthritis Disease Activity Score (JADAS27-CRP) will be assessed | Week 12 |
Percentage of Participants Achieving Inactive Disease (ID) Status by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP | Inactive Disease (ID) status by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed. | Week 12 |
Percentage of Participants Achieving Minimal Disease Activity (MDA) by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP | Minimal Disease Activity (MDA) by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed. | Week 12 |
Percentage of Participants Achieving Clinical Remission by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP | Clinical Remission by 27-joint Juvenile Arthritis Disease Activity Score (JADAS27)-CRP will be assessed. | Week 12 |
参加アシスタント
適格基準
対象年齢
小児
試験の最低年齢
1 Year
対象性別
全て
- Baseline with a total body weight of 10 kg or higher at screening and symptoms of systemic juvenile idiopathic arthritis (sJIA) according to International League of Associations for Rheumatology (ILAR) criteria for at least 6 weeks prior to Screening, with onset prior to 16 years old, and meet the following conditions:
- Must have active sJIA with at least 2 active joints at Screening and Baseline, fever more than 38°C on at least one day within 14 consecutive days before the Screening Visit, and an erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactive protein (hsCRP) > upper limit of normal (ULN) at Screening. OR At least 4 active joints at Screening and Baseline and an ESR or hsCRP > ULN at Screening.
- Must have inadequate response to previous treatment with nonsteroidal anti-inflammatory drugs and/or systemic glucocorticoids, as judged by the investigator.
- For Cohort 1, participants must not have had previous treatment with any IL-6 inhibitor. For Cohort 2, participants must have an intolerance or inadequate response to an IL-6 inhibitor as judged by the investigator.
Note: For Cohort 1, participants must be ages 2 to < 18 years old in countries where SC tocilizumab is not approved for sJIA.
- Has any type of juvenile idiopathic arthritis (JIA), other than sJIA, as defined by the ILAR criteria, and must not have a history or presence of any other autoimmune inflammatory condition other than sJIA.
- Has uncontrolled severe systemic disease and/or impeding or active macrophage activation syndrome within 1 month prior to Baseline.
アッヴィ試験中央連絡先
連絡先: ABBVIE CALL CENTER, 844-663-3742, [email protected]
44 17カ国の場所
Hyōgo
Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 251649, Kobe, Hyōgo, 650-0045, Japan
Site Coordinator, 連絡先, +81-78-945-7300
募集中
Kanagawa
St Marianna University School Of Medicine /ID# 251623, Kawasaki-shi, Kanagawa, 216-8511, Japan
募集中
Niigata
Niigata University Medical & Dental Hospital /ID# 251538, Niigata, Niigata, 951-8520, Japan
募集中
Osaka
Osaka Medical and Pharmaceutical University Hospital /ID# 252092, Takatsuki-shi, Osaka, 569-8686, Japan
募集中
Tokyo
Institute of Science Tokyo Hospital /ID# 251505, Bunkyo-ku, Tokyo, 113-8519, Japan
募集中
Arizona
Phoenix Children's Hospital /ID# 253403, Phoenix, Arizona, 85016-7710, United States
Site Coordinator, 連絡先, 602-933-3822, [email protected]
募集中
District of Columbia
Childrens National Medical Center /ID# 253344, Washington D.C., District of Columbia, 20010-2916, United States
募集中
New York
New York Medical College /ID# 253437, Valhalla, New York, 10595, United States
Site Coordinator, 連絡先, 914-504-0152
募集中
North Carolina
Levine Children's Hospital /ID# 253491, Charlotte, North Carolina, 28203, United States
募集中
Ohio
Cincinnati Childrens Hospital Medical Center /ID# 251827, Cincinnati, Ohio, 45229, United States
Site Coordinator, 連絡先, 1-513-636-3644, [email protected]
募集中
Oregon
Randall Children's Hospital /ID# 251829, Portland, Oregon, 97227-1654, United States
Site Coordinator, 連絡先, 1-503-413-3508, [email protected]
募集中
Santa Fe Province
Instituto CAICI S.R.L /ID# 251448, Rosario, Santa Fe Province, 2000, Argentina
募集中
Tucumán Province
Centro de Investigaciones Medicas Tucuman /ID# 251781, San Miguel de Tucumán, Tucumán Province, 4000, Argentina
募集中
Hospital de Niños de la Santisima Trinidad /ID# 252736, Córdoba, 5014, Argentina
Site Coordinator, 連絡先, 351 458-6405
募集中
Victoria
Monash Health - Monash Medical Centre /ID# 251691, Clayton, Victoria, 3168, Australia
完了
Royal Children's Hospital /ID# 251663, Parkville, Victoria, 3052, Australia
完了
Vorarlberg
Landeskrankenhaus Bregenz /ID# 266317, Bregenz, Vorarlberg, 6900, Austria
募集中
Minas Gerais
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769, Juiz de Fora, Minas Gerais, 36010-570, Brazil
完了
Hospital Sao Paulo /ID# 251765, São Paulo, 04023-062, Brazil
募集中
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764, São Paulo, 05403-000, Brazil
募集中
Chongqing Municipality
The Childrens Hospital of Chongqing Medical University /ID# 251539, Chongqing, Chongqing Municipality, 400065, China
募集中
Jiangsu
Children'S Hospital Of Soochow University /ID# 251755, Suzhou, Jiangsu, 215025, China
募集中
Shaanxi
Xi'an Children's Hospital /ID# 251693, Xi'an, Shaanxi, 710054, China
募集中
Shanghai Municipality
Children's Hospital of Fudan University /ID# 251619, Shanghai, Shanghai Municipality, 200032, China
募集中
Zhejiang
The Children's Hospital of Zhejiang University School of Medicine /ID# 251754, Hangzhou, Zhejiang, 310003, China
募集中
Baden-Wurttemberg
Universitaetsklinikum Freiburg /ID# 253288, Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Site Coordinator, 連絡先, [email protected]
募集中
North Rhine-Westphalia
Asklepios Klinik Sankt Augustin /ID# 251565, Sankt Augustin, North Rhine-Westphalia, 53757, Germany
募集中
St. Josef-Stift Sendenhorst /ID# 268680, Sendenhorst, North Rhine-Westphalia, 48324, Germany
募集中
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564, Hamburg, 22081, Germany
募集中
Semmelweis Egyetem /ID# 266750, Budapest, 1085, Hungary
募集中
Firenze
Azienda Ospedaliero Universitaria Meyer /ID# 251775, Florence, Firenze, 50139, Italy
募集中
Genova
IRCCS Istituto Giannina Gaslini /ID# 251776, Genoa, Genova, 16147, Italy
募集中
Jalisco
CREA de Guadalajara SC /ID# 252917, Guadalajara, Jalisco, 44620, Mexico
募集中
Universitair Medisch Centrum Utrecht /ID# 267435, Utrecht, 3584 CX, Netherlands
募集中
Barcelona
Hospital Sant Joan de Deu /ID# 251353, Esplugues de Llobregat, Barcelona, 08950, Spain
募集中
Hospital Universitario y Politecnico La Fe /ID# 251352, Valencia, 46026, Spain
Site Coordinator, 連絡先, +34 961 244 357, [email protected]
募集中
Västra Götaland County
Queen Silvia Children's Hosp /ID# 251318, Gothenburg, Västra Götaland County, 416 85, Sweden
Site Coordinator, 連絡先, +46313435865
募集中
National Taiwan University Hospital /ID# 267387, Taipei, 100, Taiwan
募集中
Linkou Chang Gung Memorial Hospital /ID# 267390, Taoyuan, 333, Taiwan
募集中
Gazi University Medical Faculty /ID# 253677, Ankara, 06560, Turkey (Türkiye)
募集中
Istanbul University Istanbul Medical Faculty /ID# 251652, Istanbul, 34093, Turkey (Türkiye)
募集中
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651, Istanbul, 34098, Turkey (Türkiye)
募集中
Umraniye Training and Res Hosp /ID# 251653, Istanbul, 34764, Turkey (Türkiye)
募集中
Greater London
Great Ormond Street Children's Hospital /ID# 251512, London, Greater London, WC1N 3HZ, United Kingdom
募集中