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
- Registration Number
- NCT04088409
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
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Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn's disease or ulcerative colitis.
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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.
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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.
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Participants must not have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy).
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Participants must not have a current or recent (<4 weeks prior to baseline) infection.
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Participants must not have a positive test for hepatitis B virus (HBV) at screening.
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Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Baricitinib Baricitinib Participants ≥9 to \<18 years of age were administered 4 milligrams (mg) baricitinib once daily (QD). Participants \<9 years of age were administered 2 mg baricitinib QD. Participants \<6 years of age received an oral suspension. Participants ≥6 to \<12 years of age had the option of receiving an oral suspension. Participants \>12 years of age were supplied tablets. Adalimumab Adalimumab Participants received adalimumab administered subcutaneously (SC) once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing \<30 kilograms (kg), or 40 mg every 2 weeks for participants weighing ≥30 kg.
- Primary Outcome Measures
Name Time Method Part A: Percentage of Responders for Baricitinib at Week 24 Week 24 Response was 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
Name Time Method Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye Baseline, Week 24 Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye. Outcome data will be provided after the study is completed.
Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable) Baseline, Week 24 Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable). Outcome data will be provided after the study is completed.
Percentage of Responders in Participants With Bilateral Uveitis Disease at Baseline 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. Outcome data will be provided after the study is completed.
Change From Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test Baseline, Week 24 Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test. Outcome data will be provided after the study is completed.
Time to Inactive Anterior Uveitis Disease (Using SUN Definition) Baseline through Week 24 Time to Inactive Anterior Uveitis Disease (Using SUN Definition). Outcome data will be provided after the study is completed.
Percentage of Participants Who Are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day Week 24 Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to \<2 Drops Per Day. Outcome data will be provided after the study is completed.
Change From Baseline in Vitreous Haze Baseline, Week 24 Change from Baseline in Vitreous Haze. Outcome data will be provided after the study is completed.
Change From Baseline in Grade of Flare in the Anterior Chamber Baseline, Week 24 Change from Baseline in Grade of Flare in the Anterior Chamber. Outcome data will be provided after the study is completed.
Percentage of Participants With Inactive Anterior Uveitis (Using SUN Definition) Week 24 Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition). Outcome data will be provided after the study is completed.
Pediatric American College of Rheumatology (PediACR30) Response Rate (For Participants With JIA-U) Week 24 PediACR30 Response Rate (For Participants with JIA-U). Outcome data will be provided after the study is completed.
Change From Baseline in Overall Uveitis-Related Disability Baseline, Week 24 Change from Baseline in Overall Uveitis-Related Disability. Outcome data will be provided after the study is completed.
Trial Locations
- Locations (20)
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
🇫🇷Le Kremlin Bicetre, France
Hôpital Universitaire Necker Enfants Malades
🇫🇷Paris, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers Cedex, France
Asklepios Klinik Sankt Augustin
🇩🇪Sankt Augustin, Nordrhein-Westfalen, Germany
HELIOS Klinikum Berlin-Buch
🇩🇪Berlin, Germany
Charité Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
🇩🇪Hamburg, Germany
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliero Universitaria Meyer
🇮🇹Firenze, Italy
Hospital Universitario La Fe de Valencia
🇪🇸Valencia, Spain
Hospital Sant Joan de Déu
🇪🇸Esplugues de Llobregat, Barcelona, Spain
Hospital Infantil Universitario Niño Jesús
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Madrid, Comunidad De, Spain
Bristol Royal Hospital for Children
🇬🇧Bristol, Bristol, City Of, United Kingdom
Cambridge Clinical Research Facility
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Alder Hey Children's Hospital
🇬🇧Liverpool, England, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle upon Tyne, England, United Kingdom
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, Hampshire, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
🇬🇧London, United Kingdom
Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom