A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

Официальное название

A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)

Обзор

The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.

Вмешательства

• Препарат Baricitinib
  Administered orally.

Первичные конечные точки

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) [Срок оценки: Baseline through Week 264]
• Number of Participants with Permanent Investigational Product Discontinuations [Срок оценки: Baseline through Week 264]

Вторичные конечные точки (12)

• Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) [Срок оценки: Week 264]
• Proportion of Participants who have Disease Flare [Срок оценки: Baseline through Week 264]
• Proportion of Participants with Inactive Disease [Срок оценки: Week 264]
• Proportion of Participants with Minimal Disease Activity [Срок оценки: Week 264]
• Proportion of Participants in Remission [Срок оценки: Week 264]
• Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27) [Срок оценки: Baseline, Week 264]
• Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item [Срок оценки: Baseline, Week 264]
• Change from Baseline in Psoriasis Area and Severity Index (PASI) [Срок оценки: Baseline, Week 264]
• Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index [Срок оценки: Baseline, Week 264]
• Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) [Срок оценки: Baseline, Week 264]
• Change from Baseline in Immunoglobulin Levels [Срок оценки: Baseline, Week 264]
• Change from Baseline in Immunophenotyping (T Cells) [Срок оценки: Baseline, Week 264]

Критерии участия

Критерии включения

• Participants must have completed a previous study of baricitinib for the treatment of JIA.

Критерии исключения

• Participants must not have had a permanent discontinuation of baricitinib in the prior study.
• Participants must have not developed an allergy to baricitinib.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Япония · 11 центров

• Institute of Science Tokyo Hospital — Bunkyō
• Chiba Children's Hospital — Chiba
• Kagoshima University Hospital — Kagoshima
• Kanazawa University Hospital — Kanazawa
• Niigata University Medical & Dental Hospital — Niigata
• Saitama Children's Medical Center — Saitama-shi
• Miyagi Children's Hospital — Sendai
• Tokyo Women's Medical University Hospital — Shinjuku-ku
• … и ещё 3 центра

Италия · 8 центров

• Azienda Ospedaliera Spedali Civili di Brescia — Brescia
• Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti — Chieti
• IRCCS Istituto Giannina Gaslini — Genova
• Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO — Milan
• Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan
• University of Naples Federico II — Naples
• Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli — Palermo
• Ospedale Infantile Burlo Garofolo — Trieste

Германия · 6 центров

• Helios Klinikum Berlin-Buch — Berlin
• Charité Campus Virchow-Klinikum — Berlin
• Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari — Hamburg
• Universitätsklinikum Heidelberg — Heidelberg
• Asklepios Klinik Sankt Augustin — Sankt Augustin
• Universitaetsklinikum Tuebingen — Tübingen

Франция · 5 центров

• Hospices Civils de Lyon - Hôpital Femme Mère Enfant — Bron
• Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre — Le Kremlin-Bicêtre
• Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau — Nîmes
• Hôpital Universitaire Necker Enfants Malades — Paris
• Centre Hospitalier Universitaire de Poitiers — Poitiers

Мексика · 5 центров

• Investigacion y Biomedicina de Chihuahua — Chihuahua City
• Instituto de Investigaciones Clínicas para la Salud — Durango
• Crea de Guadalajara — Guadalajara
• Clinstile, S.A. de C.V. — México
• Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey

Испания · 5 центров

• Hospital Sant Joan de Déu — Esplugues de Llobregat
• Hospital Universitario Ramón y Cajal — Madrid
• Hospital Universitario La Paz — Madrid
• Hospital Universitario Virgen Del Rocio — Seville
• Hospital Universitari i Politecnic La Fe — Valencia

Великобритания · 5 центров

• Bristol Royal Hospital for Children — Bristol
• Alder Hey Children's Hospital — Liverpool
• Great Ormond Street Hospital For Children NHS Foundation Trust — London
• Oxford University Hospitals - Nuffield Orthopaedic Centre — Oxford
• Sheffield Children's Hospital — Sheffield

Китай · 4 центра

• Beijing Children's hospital, Capital Medical University — Пекин
• The Children's Hospital of Chongqing Medical University — Чунцин
• Childrens Hospital of Nanjing Medical University — Нанкин
• Children's Hospital of Soochow University — Сучжоу

Израиль · 4 центра

• Rambam Health Care Campus — Haifa
• Meir Medical Center — Kfar Saba
• Schneider Children's Medical Center — Petah Tikva
• Sheba Medical Center — Ramat Gan

Австралия · 3 центра

• Royal Children's Hospital — Melbourne
• Perth Children's Hospital — Perth
• The Children's Hospital at Westmead — Westmead

Бельгия · 3 центра

• Cliniques universitaires Saint-Luc — Brussels
• UZ Gent — Ghent
• UZ Leuven — Leuven

Бразилия · 3 центра

• Faculdade de Medicina da UNESP — Botucatu
• Universidade Federal de Sao Paulo — São Paulo
• Instituto da Crianca do Hospital das Clinicas da FMUSP — São Paulo

Чехия · 3 центра

• Detska nemocnice FN Brno — Brno
• Vseobecna fakultni nemocnice v Praze — Prague
• Fakultni nemocnice Motol — Prague

Индия · 3 центра

• Sri Ramachandra MedicaL College & Research Institute — Chennai
• Sir Ganga Ram Hospital — New Delhi
• Christian Medical College Vellore — Vellore

Польша · 3 центра

• Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie — Krakow
• Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi — Lodz
• Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji — Warsaw

Аргентина · 2 центра

• Instituto CAICI SRL — Rosario
• Centro de Investigaciones Médicas Tucuman — SAN M. de Tucuman

Россия · 2 центра

• Federal State Budgetary Scientific Institution Research Institute Rheumatology named after — Moscow
• Scientific Center of Children's Health — Moscow

Австрия · 1 центр

• Landeskrankenhaus Bregenz — Bregenz

Дания · 1 центр

• Aarhus Universitetshospital, Skejby — Aarhus

Turkey (Türkiye) · 1 центр

• Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine — Istanbul

Идентификаторы

NCT: NCT03773965 · 16278 · I4V-MC-JAHX · 2017-004471-31

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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