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Trial record 20 of 62 for:    Baricitinib

A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

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ClinicalTrials.gov Identifier: NCT04088409
Recruitment Status : Not yet recruiting
First Posted : September 12, 2019
Last Update Posted : November 5, 2019
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 given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.

Condition or disease Intervention/treatment Phase
Uveitis Drug: Baricitinib Drug: Adalimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Active-Controlled, Safety, and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
Estimated Study Start Date : October 31, 2019
Estimated Primary Completion Date : March 3, 2022
Estimated Study Completion Date : March 2, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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

Active Comparator: Adalimumab
Adalimumab given subcutaneously (SC).
Drug: Adalimumab
Administered SC




Primary Outcome Measures :
  1. Percentage of Responders [ Time Frame: Week 24 ]
    Response is defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline.


Secondary Outcome Measures :
  1. Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye

  2. Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable) [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable)

  3. Percentage of Responders in Participants with Bilateral Uveitis Disease at Baseline [ Time Frame: Week 24 ]
    Response is defined according to the SUN criteria as a 2-step decrease in the level of anterior chamber cells in the most severely affected eye at baseline (or both eyes if the inflammation grade is the same in both eyes) and a 1-step decrease in the level of anterior chamber cells in the less severely affected eye at baseline.

  4. Change from Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test

  5. Change from Baseline in Vitreous Haze [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in Vitreous Haze

  6. Change from Baseline in Grade of Flare in the Anterior Chamber [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in Grade of Flare in the Anterior Chamber

  7. Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition) [ Time Frame: Week 24 ]
    Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition)

  8. Time to Inactive Anterior Uveitis Disease (Using SUN Definition) [ Time Frame: Baseline through Week 24 ]
    Time to Inactive Anterior Uveitis Disease (Using SUN Definition)

  9. Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day [ Time Frame: Week 24 ]
    Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day

  10. Time to Treatment Response [ Time Frame: Baseline through Week 24 ]
    Response is defined by a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero in the most severely affected eye at baseline

  11. PediACR30 Response Rate (For Participants with JIA-U) [ Time Frame: Week 24 ]
    PediACR30 Response Rate (For Participants with JIA-U)

  12. Change from Baseline in Overall Uveitis-Related Disability [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in Overall Uveitis-Related Disability



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have a diagnosis of JIA-U or chronic anterior antinuclear antibody (ANA) positive uveitis without systemic features.
  • Participants must have active anterior uveitis, defined as cellular infiltrate in the anterior chamber of SUN criteria grade ≥1+ at screening and randomization, despite prior treatment with adequate doses of topical steroid therapy and methotrexate (MTX).
  • Participants must have an inadequate response or intolerance to MTX.
  • Participants must be on a stable dose of corticosteroid eye drops for at least 2 weeks prior to screening with a maximum of 4 drops/day/eye at screening.
  • Participants and their partners of child bearing potential must agree to use 2 effective methods of contraception for the duration of the study and for at least 1 week following the last dose of investigational product.

Exclusion 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 any contraindications to adalimumab.

    • Exception: Participants who are biologic disease-modifying antirheumatic drug (bDMARD) inadequate response or intolerance with a contraindication to adalimumab may be enrolled, as they will be assigned to baricitinib.
  • Participants must not have increased intraocular pressure ≥25 millimeters of mercury (mm Hg) or that required treatment, including increases in medications, surgery, or hospitalization, within 4 weeks prior to baseline that, in the opinion of the investigator, would pose an unacceptable risk to the participant.
  • Participants must not have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy).
  • Participants must not have a current or recent (<4 weeks prior to baseline) infection.
  • Participants must not have a positive test for hepatitis B virus (HBV) at screening.
  • 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): NCT04088409


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
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France
Hôpital Femme Mère Enfant Not yet recruiting
Bron, France, 69500
Contact    330427856131      
Principal Investigator: Alexandre Belot         
Centre Hospitalier Universitaire de Bicetre Not yet recruiting
Le Kremlin Bicetre, France, 94270
Contact    33145213246      
Principal Investigator: Isabelle Kone Paut         
CHU de Nimes Hopital Caremeau Not yet recruiting
Nimes Cedex 9, France, 30029
Contact    33466686868      
Principal Investigator: Tu Anh Tran         
GH Necker - Enfants Malades Not yet recruiting
Paris Cedex 15, France, 75743
Contact    33144494828      
Principal Investigator: Pierre Quartier Dit Maire         
CHU Poitiers - Hopital Jean Bernard Not yet recruiting
Poitiers Cedex, France, 86021
Contact    0033145213247      
Principal Investigator: Elisabeth Gervais         
Germany
Asklepios Klinik Sankt Augustin GmbH Not yet recruiting
Saint Augustin, Nordrhein-Westfalen, Germany, 53757
Contact    00492241249201      
Principal Investigator: Gerd Horneff         
HELIOS Klinikum Berlin-Buch Not yet recruiting
Berlin, Germany, 13125
Contact    004930940114510      
Principal Investigator: Ralf Trauzeddel         
Charité Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 13353
Contact    4930450666176      
Principal Investigator: Kirsten Minden         
Hamburger Zentrum für Kinder und Jugendrheumatologie Not yet recruiting
Hamburg, Germany, 22081
Contact    00494020923697      
Principal Investigator: Ivan Foeldvari         
Italy
Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini - Reumatologia Pediatrica Not yet recruiting
Genova, Liguria, Italy, 16147
Contact    3901056362916      
Principal Investigator: Roberta Caorsi         
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Not yet recruiting
Milano, Lombardia, Italy
Contact    +390390255031      
Principal Investigator: Giovanni Filocamo         
Spain
Hospital Sant Joan de Déu Recruiting
Esplugues de Llobregat, Barcelona, Spain, 08950
Contact    34936009733      
Principal Investigator: Jordi Antón López         
Hospital Infantil Niño Jesus Recruiting
Madrid, Spain, 28009
Contact    915035900529      
Principal Investigator: Daniel Clemente         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact    9172770002526      
Principal Investigator: Sara Murias Loza         
Hospital Universitario La Fe de Valencia Recruiting
Valencia, Spain, 46026
Contact    961244792      
Principal Investigator: Inmaculada Calvo         
United Kingdom
Cambridge Clinical Research Facility Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0SP
Contact    441223348577      
Principal Investigator: Kate Armon         
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact    442381204829      
Principal Investigator: Theresa Alice Leahy         
Great Ormond Street Hospital Recruiting
Bloomsbury, London, United Kingdom, WC1N 3JH
Contact    07414744845      
Principal Investigator: Sandrine Lacassagne         
Royal Victoria Infirmary Recruiting
Newcastle, N'castle-upon-tyne, United Kingdom, NE14LP
Contact    07973915395      
Principal Investigator: Sharmila Jandial         
Sheffield Children's Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2TH
Contact    441142262305      
Principal Investigator: Daniel Hawley         
Bristol Royal Hospital for Children Recruiting
Bristol, United Kingdom, BS2 8BJ
Contact    07951262155      
Principal Investigator: Athimalaipet Vaidyanathan Ramanan         
Alder Hey Children's Hospital Recruiting
Liverpool, United Kingdom, L12 2AP
Contact    01512284811      
Principal Investigator: Gavin Cleary         
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: NCT04088409     History of Changes
Other Study ID Numbers: 16277
I4V-MC-JAHW ( Other Identifier: Eli Lilly and Company )
2019-000119-10 ( EudraCT Number )
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 1, 2019
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://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases
Adalimumab
Antibodies
Antibodies, Antinuclear
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents