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Trial record 7 of 63 for:    Baricitinib

A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088396
Recruitment Status : Not yet recruiting
First Posted : September 12, 2019
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA).

Condition or disease Intervention/treatment Phase
Systemic Juvenile Idiopathic Arthritis Drug: Baricitinib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : April 7, 2023
Estimated Study Completion Date : April 7, 2023


Arm Intervention/treatment
Experimental: Baricitinib
Baricitinib given orally.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Placebo Comparator: Placebo
Placebo given orally.
Drug: Placebo
Administered orally




Primary Outcome Measures :
  1. Time to Disease Flare [ Time Frame: Week 24 to End of Double Blind Withdrawal (DBW) Period (Disease Flare or up to Week 56) ]
    Time to Disease Flare


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]
    Percentage of Participants Achieving PedACR30

  2. Percentage of Participants with Inactive Disease [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]
    Percentage of Participants with Inactive Disease

  3. Percentage of Participants with Minimal Disease Activity [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]
    Percentage of Participants with Minimal Disease Activity

  4. Percentage of Participants in Remission [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]
    Percentage of Participants in Remission

  5. Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 [ Time Frame: Baseline, End of DBW Period (Disease Flare or up to Week 56) ]
    Change from Baseline in JADAS-27

  6. 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, End of DBW Period (Disease Flare or up to Week 56) ]
    Change from Baseline in Arthritis-Related Pain Severity as Measured by the CHAQ Pain VAS Item

  7. Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]
    PK: Cmax, ss of Baricitinib

  8. PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]
    PK: AUC, ss of Baricitinib



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years.
  • Participants must have arthritis in 1 or more joints with or preceded by fever of at least 2 weeks' duration that is documented to be daily (quotidian) fever for at least 3 days, and accompanied by 1 or more of the following:

    • Evanescent (nonfixed) erythematous rash
    • Generalized lymph node enlargement
    • Hepatomegaly and/or splenomegaly
    • Serositis
  • Participants must have at least 2 active joints at screening and baseline.

Exclusion Criteria:

  • Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis.
  • Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria.
  • Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn's disease or ulcerative colitis.
  • Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis.
  • Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study.
  • Participants must not have biologic features of Macrophage Activation Syndrome (MAS).
  • Participants must not have a current or recent (<4 weeks prior to baseline) clinically serious infection.
  • Participants must not have a positive test for hepatitis B virus.
  • Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088396


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
Hide Hide 73 study locations
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Argentina
Instituto Centralizado de Asistencia e Investigacion Clinica
Rosario, Santa Fe, Argentina, S2000
Contact    543414248045      
Principal Investigator: Diego Oscar Viola         
Hospital Pedro de Elizalde
Buenos Aires, Argentina, C1270AAN
Contact    5491149745508      
Principal Investigator: Ruben Cuttica         
Centro Medico Privado de Reumatologia
Tucuman, Argentina, T4000AXL
Contact    543814200180      
Principal Investigator: Alberto Spindler         
Austria
Universitätsklinik Innsbruck
Innsbruck, Tirol, Austria, 6020
Contact    004351250423500      
Principal Investigator: Jürgen Brunner         
Medizinische Universität Wien - Kinder und Jugendheilkunde
Vienna, Wien, Austria, 1090
Contact    004314040030780      
Principal Investigator: Wolfgang Emminger         
Belgium
UZ Gent-Reuma
Gent, East Flanders, Belgium, 9000
Contact    3293325271      
Principal Investigator: Joke Dehoorne         
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Vlaams-Brabant, Belgium, 3000
Contact    003216343801      
Principal Investigator: Carine Wouters         
UCL- Saint Luc
Bruxelles, Belgium, 1200
Contact    003227645391      
Principal Investigator: Bernard Lauwerys         
Brazil
Hospital de Clinicas UNICAMP
Campinas, SP, Brazil, 13083-970
Contact    551935217106      
Principal Investigator: Simone Appenzeller         
Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil, 18618-970
Contact    551438801476      
Principal Investigator: Claudia Saad Magalhães         
Czechia
Detska fakultni nemocnice
Brno, Brno-město, Czechia, 613 00
Contact    420532234482      
Principal Investigator: Marcel Schuller         
Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze
Prague, Czechia, 121 09
Contact    420224967074      
Principal Investigator: Pavla Dolezalova         
Denmark
Aarhus Universitetshospital
Aarhus, Midtjylland, Denmark, 8200
Contact    78451667      
Principal Investigator: Mia Glerup         
France
CHU de Nimes Hopital Caremeau
Nimes Cedex 9, Gard, France, 30029
Contact    33601728537      
Principal Investigator: Tu Anh Tran         
Hôpital Femme Mère Enfant
Bron, Rhône-Alpes, France, 69500
Contact    330427856131      
Principal Investigator: Alexandre Belot         
CHU Poitiers - Hopital Jean Bernard
Poitiers Cedex, Vienne, France, 86021
Contact    0549444370      
Principal Investigator: Elisabeth Gervais         
Centre Hospitalier Universitaire de Bicetre
Le Kremlin Bicetre, France, 94275
Contact    33145213247      
Principal Investigator: Isabelle Kone Paut         
GH Necker - Enfants Malades
Paris, France, 75015
Contact    33144494828      
Principal Investigator: Pierre Quartier Dit Maire         
CHU de Nancy Hop D'Enfants de Brabois
Vandoeuvre Les Nancy Cedex, France, 54511
Contact    +33144494828      
Principal Investigator: Irène Lemelle         
Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Württemberg, Germany, 79106
Contact    4976127043000      
Principal Investigator: Markus Hufnagel         
Universitätsklinikum Münster
Münster, Nordrhein-Westfalen, Germany, 48149
Contact    492518358178      
Principal Investigator: Dirk Foell         
Asklepios Klinik Sankt Augustin GmbH
Saint Augustin, Nordrhein-Westfalen, Germany, 53757
Contact    00492241249201      
Principal Investigator: Gerd Horneff         
Universitätsklinikum Carl Gustav Carus
Dresden, Sachsen, Germany, 01307
Contact    493514582508      
Principal Investigator: Reinhard Berner         
HELIOS Klinikum Berlin-Buch
Berlin, Germany, 13125
Contact    004930940114510      
Principal Investigator: Ralf Trauzeddel         
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Contact    4930450666176      
Principal Investigator: Kirsten Minden         
Klinikum Bremen-Mitte gGmbH
Bremen, Germany, 28177
Contact    494214974710      
Principal Investigator: Frank Weller-Heinemann         
Hamburger Zentrum für Kinder und Jugendrheumatologie
Hamburg, Germany, 22081
Contact    00494020923697      
Principal Investigator: Ivan Foeldvari         
India
SRI Ramachandra Medical College and Hospital
Porur, Chennai, India, 600116
Contact    9952552330      
Principal Investigator: Mahesh Janarthanan         
Sir Ganga Ram Hospital
New Delhi, Delhi, India, 110060
Contact    9910277292      
Principal Investigator: Sujata Sawhney         
Christian Medical College and Hospital
Vellore, Tamil Nadu, India, 632004
Contact    9488469989      
Principal Investigator: Sathish Kumar         
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India, 226014
Contact    8004904389      
Principal Investigator: A K Aggarwal         
Israel
Sheba Medical Center
Ramat Gan, HaMerkaz, Israel, 5262100
Contact    972547382804      
Principal Investigator: Irit Tirosh         
Meir Medical Center
Kfar Saba, Israel, 4428164
Contact    97297472555      
Principal Investigator: Yosef Uziel         
Schneider Medical Center
Petah Tiqva, Israel, 4920235
Contact    972544334856      
Principal Investigator: Liora Harel         
Italy
Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini - Reumatologia Pediatrica
Genova, Liguria, Italy, 16147
Contact    3396149481      
Principal Investigator: Roberta Caorsi         
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milano, Lombardia, Italy, 20122
Contact    3338278152      
Principal Investigator: Rolando Cimaz         
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico
Milano, Lombardia, Italy, 20122
Contact    0390255031      
Principal Investigator: Giovanni Filocamo         
Azienda Ospedaliera - Universitaria Pisana
Pisa, Toscana, Italy, 56126
Contact    39050992222      
Principal Investigator: Rita Consolini         
ASST Spedali Civili - Università degli Studi
Brescia, Italy, 25123
Contact    390303995716      
Principal Investigator: Marco Cattalini         
Ospedale SS. Annunziata
Chieti, Italy, 66100
Contact    3393877353      
Principal Investigator: Luciana Breda         
Azienda Ospedaliera Universitaria Federico II
Napoli, Italy, 80131
Contact    393474886088      
Principal Investigator: Maria Alessio         
Istituto Burlo Garofolo
Trieste, Italy, 34137
Contact    390403785301      
Principal Investigator: Serena Pastore         
Japan
Kanagawa Prefectural Childrens Medical Center
Yokohama, Kanagawa, Japan, 232-8555
Contact    81120360605      
Principal Investigator: Tomoyuki Imagawa         
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Contact    81120360605      
Principal Investigator: Shuichi Ito         
Miyagi Children's Hospital
Sendai-shi, Miyagi, Japan, 989 3126
Contact    81120360605      
Principal Investigator: Hiroaki Umebayashi         
Osaka Medical College Hospital
Takatsuki, Osaka, Japan, 569-8686
Contact    81120360605      
Principal Investigator: Yuka Ozeki         
Tokyo Medical And Dental University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8519
Contact    81120360605      
Principal Investigator: Masaaki Mori         
Kagoshima University Hospital
Kagoshima, Japan, 890-8520
Contact    81120360605      
Principal Investigator: Yoshifumi Kawano         
Mexico
Clinstile, S.A de C.V
Cuauhtemoc, Federal District, Mexico, 06700
Contact    5552561496      
Principal Investigator: Favio Edmundo Enriquez Sosa         
CREA de Guadalajara, S.C.
Guadalajara, Jalisco, Mexico, 44620
Contact    3314172229      
Principal Investigator: Gabriel Vega Cornejo         
Hospital Univ. "Dr. José Eleuterio González"
Monterrey, Nuevo León, Mexico, 64460
Contact    00528183486173      
Principal Investigator: Nadina Eugenia Rubio Perez         
Investigación y Biomedicina de Chihuahua, SC
Chihuahua, Mexico, 31000
Contact    526144155012      
Principal Investigator: Cesar Pacheco Tena         
Instituto de Investigaciones Clínicas para la Salud
Durango, Mexico, 34000
Contact    5216188125351      
Principal Investigator: Edgar Hernandez Vargas         
Poland
Szpital Dzieciecy Sw. Ludwika
Krakow, Poland, 31-503
Contact    0048126198630      
Principal Investigator: Zbigniew Zuber         
CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej
Lodz, Poland, 91-738
Contact    0048606282070      
Principal Investigator: Elzbieta Smolewska         
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warszawa, Poland, 02-637
Contact    0048601985208      
Principal Investigator: Piotr Gietka         
Russian Federation
V.A. Nasonova Research Institute of Rheumatology
Moscow, Russian Federation, 115522
Contact    79104376506      
Principal Investigator: Irina Nikishina         
Morozov Children's City Hospital
Moscow, Russian Federation, 119049
Contact    79255858745      
Principal Investigator: Saniya Valieva         
Scientific Center of Children`s Health
Moscow, Russian Federation, 119991
Contact    0079857663490      
Principal Investigator: Ekaterina Alexeeva         
St. Petersburg State Pediatric Medical University
Saint-Petersburg, Russian Federation, 194100
Contact    0078124165212      
Principal Investigator: Vyacheslav Chasnyk         
Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain, 08950
Contact    +34932804000-71567      
Principal Investigator: Jordi Antón López         
Hospital Infantil Niño Jesus
Madrid, Spain, 28009
Contact    34616304899      
Principal Investigator: Daniel Clemente         
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Contact    34913368571      
Principal Investigator: Alina Lucica Boteanu         
Hospital Universitario La Paz
Madrid, Spain, 28046
Contact    +34917277164      
Principal Investigator: Rosa Maria Alcobendas Rueda         
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Contact    626772846      
Principal Investigator: Marisol Comacho Lovillo         
Hospital Universitario La Fe de Valencia
Valencia, Spain, 46026
Contact    961244792      
Principal Investigator: Inmaculada Calvo         
Turkey
Dokuz Eylul University Hospital
Izmir, Balçova, Turkey, 35340
Contact    905415202444      
Principal Investigator: Erbil Unsal         
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey, 34098
Contact    905322129111      
Principal Investigator: Ozgur Kasapcopur         
United Kingdom
Great Ormond Street Hospital
Bloomsbury, London, United Kingdom, WC1N 3JH
Contact    00442074059200      
Principal Investigator: Muthana Al Obaidi         
Sheffield Children's Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2TH
Contact    07834153509      
Principal Investigator: Daniel Hawley         
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Contact    07951262155      
Principal Investigator: Athimalaipet Vaidyanathan Ramanan         
Leeds Teaching Hospital
Leeds, United Kingdom, LS1 3EX
Contact    01133922955      
Principal Investigator: Mark Edward Wood         
Alder Hey Children's Hospital
Liverpool, United Kingdom, L12 2AP
Contact    4401512284811      
Principal Investigator: Kamran Mahmood         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04088396    
Other Study ID Numbers: 16275
I4V-MC-JAHU ( Other Identifier: Eli Lilly and Company )
2017-004495-60 ( EudraCT Number )
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Systemic
Fever
Flare
sJIA
JIA
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases