Clinical trial • Phase III • Musculoskeletal

Baricitinib for Juvenile idiopathic arthritis

Phase III trial of Baricitinib for Juvenile idiopathic arthritis. None/Not specified-controlled. 101 participants.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Juvenile idiopathic arthritis
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
28-02-2024
First CTIS Authorization Date
04-04-2024

Trial design

None/Not specified-controlled Phase III trial in Austria, Belgium, Czechia and others.

Comparator
None/Not specified
Target Sample Size
101

Eligibility

Recruits 101 paediatric patients.

Vulnerable Population
Vulnerable population selected: paediatric participants (ages 1 year to <18 years). Assent and parent/guardian consent materials are provided (documents include L1_SIS and ICF Parents, L1_SIS and ICF Assent forms for older and younger children, and age-specific ICFs such as L1_SIS and ICF 16 Plus_PL).

Inclusion criteria

  • {"criterion_text":"- Participants must have completed a previous study of baricitinib for the treatment of JIA"}
  • {"criterion_text":"- Participants must have not developed an allergy to baricitinib"}

Exclusion criteria

  • {"criterion_text":"- Participants must not have permanently stopped baricitinib in the prior study"}
  • {"criterion_text":"- Participants must have not developed an allergy to baricitinib"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of participants with one or more SAEs","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants with permanent investigational product discontinuations","definition_or_measurement_approach":""}

Recruitment

Registry Or Advocacy Recruitment
Yes
Planned Sample Size
101
Recruitment Window Months
133
Consent Approach
Parent/guardian informed consent and child assent processes are used for paediatric participants. Multiple age-specific consent and assent documents are listed (e.g. L1_SIS and ICF Main ICF in various languages, L1_SIS and ICF Parents, L1_SIS and ICF Assent form Older Children, L1_SIS and ICF Assent form Younger Children, country-specific ICFs such as PL and ES versions). Documents in the file list indicate availability in English, French, Dutch, Polish and Spanish; consent is provided by parent/guardian with assent from children as appropriate by age.

Methods

  • Publicis Healthcare Communications Group Limited - Patient Screening, Recruitment, and/or Retention (documented duty)
  • Pediatric Rheumatology International Trials Organization (PRINTO) - Patient Screening, Recruitment, and/or Retention (documented duty)
  • Signant Health LLC - listed as third party with responsibilities (digital/electronic vendor listed) (no explicit recruitment channel described in documents)
  • IQVIA Rds Inc. - listed as third party (no explicit recruitment channel described in documents)
  • Icon Clinical Research Limited - listed as third party (no explicit recruitment channel described in documents)
  • Other CRO/clinical research partners listed (Fortrea Inc., Macrostat (Shanghai) Clinical Research Co. Ltd., Q2 Solutions, Brightech International LLC) - listed as third parties; specific recruitment channels not described

Geography

Total Number Of Sites
38
Total Number Of Participants
101

Austria

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
09-04-2024
Processing Time Days
29
Number Of Sites
2

Sites

Site Name
LKH Bregenz
Department Name
Department of Pediatrics and Adolescent Medicine
Contact Person Name
Christian Huemer
Contact Person Email
christian.huemer@lkhb.at
Site Name
Medical University Of Vienna
Department Name
Department of Pediatrics and Adolescent Medicine
Contact Person Name
Wolfgang Emminger

Belgium

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
15-04-2024
Processing Time Days
35
Number Of Sites
3

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Pediatric rheumatology
Contact Person Name
Joke Dehoorne
Contact Person Email
joke.dehoorne@uzgent.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hematology oncology pediatric
Contact Person Name
Cecile Boulanger
Site Name
UZ Leuven
Department Name
Kinderreumatologie
Contact Person Name
Lien De Somer
Contact Person Email
lien.desomer@uzleuven.be

Czechia

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
05-04-2024
Processing Time Days
25
Number Of Sites
4

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
reumatology
Contact Person Name
Pavla Dolezalova
Contact Person Email
pavla.dolezalova@vfn.cz
Site Name
University Hospital Olomouc
Department Name
reumatology
Contact Person Name
Kateřina Bouchalová
Contact Person Email
katerina.bouchalova@fnol.cz
Site Name
Fakultni Nemocnice Brno
Department Name
reumatology
Contact Person Name
Marcel Schüller
Contact Person Email
schullerm@email.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
reumatology
Contact Person Name
Rudolf Horváth
Contact Person Email
rudolf.horvath@fnmotol.cz

Denmark

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
05-04-2024
Processing Time Days
25
Number Of Sites
2

Sites

Site Name
Aarhus Universitetshospital
Contact Person Name
Mia Glerup
Contact Person Email
miagleru@rm.dk
Site Name
Rigshospitalet
Department Name
BørneUngeAfdelingen
Contact Person Name
Charlotte Myrup
Contact Person Email
charlotte.myrup@regionh.dk

France

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
24-04-2024
Processing Time Days
44
Number Of Sites
5

Sites

Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
RHUMATOLOGIE
Contact Person Name
Elisabeth Gervais
Site Name
Bicetre Hospital
Department Name
Rhumatologie pediatrique et CEREMAIA
Contact Person Name
Isabelle Kone-Paut
Contact Person Email
isabelle.kone-paut@aphp.fr
Site Name
Hopital Necker Enfants Malades
Department Name
Unite d'Immunologie-Hematologie et Rhumatologie Pediatriques
Contact Person Name
Pierre Quartier Dit Maire
Contact Person Email
pierre.quartier@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Contact Person Name
Alexandre Belot
Contact Person Email
alexandre.belot@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service de pédiatrie
Contact Person Name
Tu-Anh Tran
Contact Person Email
tu.anh.tran@chu-nimes.fr

Germany

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
09-04-2024
Processing Time Days
29
Number Of Sites
5

Sites

Site Name
Universitaetsklinikum Tuebingen AöR
Contact Person Name
Jasmin Kuemmerle-Deschner
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Contact Person Name
Ralf Trauzeddel
Site Name
Charite Universitaetsmedizin Berlin KöR
Contact Person Name
Kirsten Minden
Contact Person Email
kirsten.minden@charite.de
Site Name
Asklepios Klinik Sankt Augustin GmbH
Contact Person Name
Gerd Horneff
Contact Person Email
g.horneff@asklepios.com
Site Name
Zentrum für Kinder- und Jugendrheumatologie
Contact Person Name
Ivan Foeldvari
Contact Person Email
foeldvari@t-online.de

Italy

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
15-05-2024
Processing Time Days
65
Number Of Sites
8

Sites

Site Name
ARNAS Civico di Cristina Benfratelli
Department Name
Dipartimento di Pediatria
Contact Person Name
Maria Cristina Maggio
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
UOC PEDIATRIA MEDIA INTENSITA' DI CURA
Contact Person Name
Giovanni Filocamo
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Clinica Pediatrica
Contact Person Name
Marco Cattalini
Contact Person Email
marco.cattalini@unibs.it
Site Name
Giannina Gaslini Institute For Scientific Hospitalization And Care
Department Name
U.O.C. Clinica Pediatrica e Reumatologia
Contact Person Name
Roberta Caorsi
Contact Person Email
robertacaorsi@gaslini.org
Site Name
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Department Name
UOSD di Pediatria ad indirizzo reumatologico
Contact Person Name
Luciana Breda
Contact Person Email
luciana.bredach@gmail.com
Site Name
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Department Name
Reumatologia Pediatrica
Contact Person Name
Achille Marino
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Department Name
Clinica Pediatrica
Contact Person Name
Alberto Tommasini
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Dipartimento Scienze Mediche Traslazionali
Contact Person Name
Maria Alessio
Contact Person Email
mariolina.alessio@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
19-04-2024
Processing Time Days
39
Number Of Sites
3

Sites

Site Name
CSK, Uniwersyteckie Centrum Pediatrii im. M.Konopnickiej
Department Name
Hospital
Contact Person Name
Elzbieta Smolewska
Contact Person Email
e.smolewska@wp.pl
Site Name
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji, Klinika Reumatologii Wieku Rozwojowego
Department Name
Hospital
Contact Person Name
Piotr Gietka
Contact Person Email
piotr.gietka@spartanska.pl
Site Name
Szpital Dzieciecy Sw. Ludwika III Oddział Kliniczny Pediatrii Reumatologii z pododdzialem alergologi
Department Name
Hospital
Contact Person Name
Zbigniew Zuber
Contact Person Email
zbyszekzuber@interia.pl

Spain

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
04-04-2024
Processing Time Days
24
Number Of Sites
6

Sites

Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Pediatric Reumatology
Contact Person Name
Daniel Clemente
Site Name
Hospital Universitario La Paz
Department Name
Pediatric Reumatology
Contact Person Name
Rosa Alcobendas
Contact Person Email
kishinev224@hotmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Pediatric Reumatology
Contact Person Name
Alina Lucica Boteanu
Contact Person Email
al_boter@yahoo.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pediatric Reumatology
Contact Person Name
Lucia Lacruz Perez
Contact Person Email
lacruz_lucper@gva.es
Site Name
Sant Joan De Deu Barcelona Hospital
Department Name
Pediatric Reumatology
Contact Person Name
Jordi Anton
Site Name
Hospital Universitario Ramon Y Cajal (additional entry listed)
Department Name
Pediatric Reumatology

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Name
Iqvia Rds Inc.
Name
Fortrea Inc.
Name
Macrostat (Shanghai) Clinical Research Co. Ltd.

Third parties

  • {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"Adjudication","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"China","full_name":"Macrostat (Shanghai) Clinical Research Co. Ltd.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q2 Solutions","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"Patient Screening, Recruitment, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Brightech International LLC","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"Italy","full_name":"Pediatric Rheumatology International Trials Organization (PRINTO)","duties_or_roles":"Patient Screening, Recruitment, and/or Retention","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Baricitinib (oral suspension - paediatric formulation)
Active Substance
Baricitinib
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
1
Maximum Dose
4 mg (maxDailyDoseAmount)
Investigational Product Name
BARICITINIB (film-coated tablet)
Active Substance
Baricitinib
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
2
Maximum Dose
4 mg (maxDailyDoseAmount)
Investigational Product Name
BARICITINIB (tablet)
Active Substance
Baricitinib
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
1
Maximum Dose
4 mg (maxDailyDoseAmount)
Investigational Product Name
BARICITINIB (film-coated tablet - scientific product entry)
Active Substance
Baricitinib
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
2
Maximum Dose
4 mg (maxDailyDoseAmount)

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