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

Official title

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)

Overview

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.

Interventions

• Drug Baricitinib
  Administered orally.

Primary outcome measures

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

Secondary outcome measures (12)

• Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) [Time frame: Week 264]
• Proportion of Participants who have Disease Flare [Time frame: Baseline through Week 264]
• Proportion of Participants with Inactive Disease [Time frame: Week 264]
• Proportion of Participants with Minimal Disease Activity [Time frame: Week 264]
• Proportion of Participants in Remission [Time frame: Week 264]
• Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27) [Time frame: 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 [Time frame: Baseline, Week 264]
• Change from Baseline in Psoriasis Area and Severity Index (PASI) [Time frame: Baseline, Week 264]
• Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index [Time frame: Baseline, Week 264]
• Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) [Time frame: Baseline, Week 264]
• Change from Baseline in Immunoglobulin Levels [Time frame: Baseline, Week 264]
• Change from Baseline in Immunophenotyping (T Cells) [Time frame: Baseline, Week 264]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Japan · 11 centers

• 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
• … and 3 more centers

Italy · 8 centers

• 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

Germany · 6 centers

• 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

France · 5 centers

• 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

Mexico · 5 centers

• 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

Spain · 5 centers

• 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

United Kingdom · 5 centers

• 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

China · 4 centers

• Beijing Children's hospital, Capital Medical University — Beijing
• The Children's Hospital of Chongqing Medical University — Chongqing
• Childrens Hospital of Nanjing Medical University — Nanjing
• Children's Hospital of Soochow University — Suzhou

Israel · 4 centers

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

Australia · 3 centers

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

Belgium · 3 centers

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

Brazil · 3 centers

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

Czechia · 3 centers

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

India · 3 centers

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

Poland · 3 centers

• 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

Argentina · 2 centers

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

Russia · 2 centers

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

Austria · 1 center

• Landeskrankenhaus Bregenz — Bregenz

Denmark · 1 center

• Aarhus Universitetshospital, Skejby — Aarhus

Turkey (Türkiye) · 1 center

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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗