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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered orally
Administered SC
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Part A: Percentage of Responders for Baricitinib at 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.
Time frame: Week 24
Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye
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.
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)
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.
Time frame: Baseline, Week 24
Percentage of Responders in Participants With Bilateral Uveitis Disease at Baseline
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.
Time frame: Week 24
Change From Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test
Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test. Outcome data will be provided after the study is completed.
Time frame: Baseline, Week 24
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Hôpital Universitaire Necker Enfants Malades
Paris, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Asklepios Klinik Sankt Augustin
Sankt Augustin, North Rhine-Westphalia, 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
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Meyer
Florence, Italy
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain
...and 10 more locations
Change From Baseline in Vitreous Haze
Change from Baseline in Vitreous Haze. Outcome data will be provided after the study is completed.
Time frame: Baseline, Week 24
Change From Baseline in Grade of Flare in the Anterior Chamber
Change from Baseline in Grade of Flare in the Anterior Chamber. Outcome data will be provided after the study is completed.
Time frame: Baseline, Week 24
Percentage of Participants With Inactive Anterior Uveitis (Using SUN Definition)
Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition). Outcome data will be provided after the study is completed.
Time frame: Week 24
Time to Inactive Anterior Uveitis Disease (Using SUN Definition)
Time to Inactive Anterior Uveitis Disease (Using SUN Definition). Outcome data will be provided after the study is completed.
Time frame: Baseline through Week 24
Percentage of Participants Who Are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day
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.
Time frame: Week 24
Pediatric American College of Rheumatology (PediACR30) Response Rate (For Participants With JIA-U)
PediACR30 Response Rate (For Participants with JIA-U). Outcome data will be provided after the study is completed.
Time frame: Week 24
Change From Baseline in Overall Uveitis-Related Disability
Change from Baseline in Overall Uveitis-Related Disability. Outcome data will be provided after the study is completed.
Time frame: Baseline, Week 24