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Die klinische Studie NCT05609630 (SELECT-sJIA) für Juvenile Idiopathische Arthritis ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
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AbbVieStudy 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) Phase 3 90 Pädiatrisch Jugendliche
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Die klinische Studie NCT05609630 (SELECT-sJIA) untersucht Behandlung im Zusammenhang mit Juvenile Idiopathische Arthritis. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 2. Oktober 2023. Es ist geplant, 90 Teilnehmer aufzunehmen. Durchgeführt von AbbVie wird der Abschluss für 1. Juni 2029 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 10. Februar 2026 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Offizieller Titel
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
Erkrankungen
Juvenile Idiopathische ArthritisWeitere Studien-IDs
- SELECT-sJIA
- M14-682
- 2022-501599-25-00 (Andere Kennung) (EU CT)
NCT-Nummer
Studienbeginn (tatsächlich)
2023-10-02
Zuletzt aktualisiert
2026-02-10
Studienende (vorauss.)
2029-06
Geplante Rekrutierung
90
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Stichwörter
Systemic Juvenile Idiopathic Arthritis
sJIA
Upadacitinib
ABT-494
sJIA
Upadacitinib
ABT-494
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellCohort 1 Upadacitinib Participants will receive upadacitinib for 52 weeks. | Upadacitinib Oral tablet or Oral solution |
Aktives VergleichspräparatCohort 1 Tocilizumab Participants will receive tocilizumab for 52 weeks. | Tocilizumab Subcutaneous injection or Intravenous infusion |
ExperimentellCohort 2 Upadacitinib Participants will receive upadacitinib for 52 weeks. | Upadacitinib Oral tablet or Oral solution |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind
Mindestalter
1 Year
Zugelassene Geschlechter
Alle
- 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.
AbbVieZentrale Studienkontakte
Kontakt: ABBVIE CALL CENTER, 844-663-3742, [email protected]
44 Studienstandorte in 17 Ländern
Baden-Wurttemberg
Universitaetsklinikum Freiburg /ID# 253288, Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Site Coordinator, Kontakt, [email protected]
Offene Rekrutierung
North Rhine-Westphalia
Asklepios Klinik Sankt Augustin /ID# 251565, Sankt Augustin, North Rhine-Westphalia, 53757, Germany
Offene Rekrutierung
St. Josef-Stift Sendenhorst /ID# 268680, Sendenhorst, North Rhine-Westphalia, 48324, Germany
Offene Rekrutierung
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 251564, Hamburg, 22081, Germany
Offene Rekrutierung
Vorarlberg
Landeskrankenhaus Bregenz /ID# 266317, Bregenz, Vorarlberg, 6900, Austria
Offene Rekrutierung
Arizona
Phoenix Children's Hospital /ID# 253403, Phoenix, Arizona, 85016-7710, United States
Site Coordinator, Kontakt, 602-933-3822, [email protected]
Offene Rekrutierung
District of Columbia
Childrens National Medical Center /ID# 253344, Washington D.C., District of Columbia, 20010-2916, United States
Offene Rekrutierung
New York
New York Medical College /ID# 253437, Valhalla, New York, 10595, United States
Site Coordinator, Kontakt, 914-504-0152
Offene Rekrutierung
North Carolina
Levine Children's Hospital /ID# 253491, Charlotte, North Carolina, 28203, United States
Offene Rekrutierung
Ohio
Cincinnati Childrens Hospital Medical Center /ID# 251827, Cincinnati, Ohio, 45229, United States
Site Coordinator, Kontakt, 1-513-636-3644, [email protected]
Offene Rekrutierung
Oregon
Randall Children's Hospital /ID# 251829, Portland, Oregon, 97227-1654, United States
Site Coordinator, Kontakt, 1-503-413-3508, [email protected]
Offene Rekrutierung
Santa Fe Province
Instituto CAICI S.R.L /ID# 251448, Rosario, Santa Fe Province, 2000, Argentina
Offene Rekrutierung
Tucumán Province
Centro de Investigaciones Medicas Tucuman /ID# 251781, San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Offene Rekrutierung
Hospital de Niños de la Santisima Trinidad /ID# 252736, Córdoba, 5014, Argentina
Site Coordinator, Kontakt, 351 458-6405
Offene Rekrutierung
Victoria
Monash Health - Monash Medical Centre /ID# 251691, Clayton, Victoria, 3168, Australia
Abgeschlossen
Royal Children's Hospital /ID# 251663, Parkville, Victoria, 3052, Australia
Abgeschlossen
Minas Gerais
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 251769, Juiz de Fora, Minas Gerais, 36010-570, Brazil
Abgeschlossen
Hospital Sao Paulo /ID# 251765, São Paulo, 04023-062, Brazil
Offene Rekrutierung
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 251764, São Paulo, 05403-000, Brazil
Offene Rekrutierung
Chongqing Municipality
The Childrens Hospital of Chongqing Medical University /ID# 251539, Chongqing, Chongqing Municipality, 400065, China
Offene Rekrutierung
Jiangsu
Children'S Hospital Of Soochow University /ID# 251755, Suzhou, Jiangsu, 215025, China
Offene Rekrutierung
Shaanxi
Xi'an Children's Hospital /ID# 251693, Xi'an, Shaanxi, 710054, China
Offene Rekrutierung
Shanghai Municipality
Children's Hospital of Fudan University /ID# 251619, Shanghai, Shanghai Municipality, 200032, China
Offene Rekrutierung
Zhejiang
The Children's Hospital of Zhejiang University School of Medicine /ID# 251754, Hangzhou, Zhejiang, 310003, China
Offene Rekrutierung
Semmelweis Egyetem /ID# 266750, Budapest, 1085, Hungary
Offene Rekrutierung
Firenze
Azienda Ospedaliero Universitaria Meyer /ID# 251775, Florence, Firenze, 50139, Italy
Offene Rekrutierung
Genova
IRCCS Istituto Giannina Gaslini /ID# 251776, Genoa, Genova, 16147, Italy
Offene Rekrutierung
Hyōgo
Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 251649, Kobe, Hyōgo, 650-0045, Japan
Site Coordinator, Kontakt, +81-78-945-7300
Offene Rekrutierung
Kanagawa
St Marianna University School Of Medicine /ID# 251623, Kawasaki-shi, Kanagawa, 216-8511, Japan
Offene Rekrutierung
Niigata
Niigata University Medical & Dental Hospital /ID# 251538, Niigata, Niigata, 951-8520, Japan
Offene Rekrutierung
Osaka
Osaka Medical and Pharmaceutical University Hospital /ID# 252092, Takatsuki-shi, Osaka, 569-8686, Japan
Offene Rekrutierung
Tokyo
Institute of Science Tokyo Hospital /ID# 251505, Bunkyo-ku, Tokyo, 113-8519, Japan
Offene Rekrutierung
Jalisco
CREA de Guadalajara SC /ID# 252917, Guadalajara, Jalisco, 44620, Mexico
Offene Rekrutierung
Universitair Medisch Centrum Utrecht /ID# 267435, Utrecht, 3584 CX, Netherlands
Offene Rekrutierung
Barcelona
Hospital Sant Joan de Deu /ID# 251353, Esplugues de Llobregat, Barcelona, 08950, Spain
Offene Rekrutierung
Hospital Universitario y Politecnico La Fe /ID# 251352, Valencia, 46026, Spain
Site Coordinator, Kontakt, +34 961 244 357, [email protected]
Offene Rekrutierung
Västra Götaland County
Queen Silvia Children's Hosp /ID# 251318, Gothenburg, Västra Götaland County, 416 85, Sweden
Site Coordinator, Kontakt, +46313435865
Offene Rekrutierung
National Taiwan University Hospital /ID# 267387, Taipei, 100, Taiwan
Offene Rekrutierung
Linkou Chang Gung Memorial Hospital /ID# 267390, Taoyuan, 333, Taiwan
Offene Rekrutierung
Gazi University Medical Faculty /ID# 253677, Ankara, 06560, Turkey (Türkiye)
Offene Rekrutierung
Istanbul University Istanbul Medical Faculty /ID# 251652, Istanbul, 34093, Turkey (Türkiye)
Offene Rekrutierung
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 251651, Istanbul, 34098, Turkey (Türkiye)
Offene Rekrutierung
Umraniye Training and Res Hosp /ID# 251653, Istanbul, 34764, Turkey (Türkiye)
Offene Rekrutierung
Greater London
Great Ormond Street Children's Hospital /ID# 251512, London, Greater London, WC1N 3HZ, United Kingdom
Offene Rekrutierung