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Active (not recruiting) Phase 3 NCT04088409

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

Phase 3 – large-scale trial before approval
Conditions: Uveitis

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Baricitinib
DRUG
Adalimumab
DRUG
Locations 20
France (3)
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre
Hôpital Universitaire Necker Enfants Malades
Paris
Centre Hospitalier Universitaire de Poitiers
Poitiers
Germany (4)
HELIOS Klinikum Berlin-Buch
Berlin
Charité Campus Virchow-Klinikum
Berlin
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
Hamburg
Asklepios Klinik Sankt Augustin
Sankt Augustin , North Rhine-Westphalia
Italy (2)
Azienda Ospedaliero Universitaria Meyer
Florence
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan , Lombardy
Spain (4)
Hospital Sant Joan de Déu
Esplugues de Llobregat , Barcelona
Hospital Infantil Universitario Niño Jesús
Madrid , Madrid, Comunidad de
Hospital Universitario La Paz
Madrid , Madrid, Comunidad de
Hospital Universitario La Fe de Valencia
Valencia
United Kingdom (7)
Bristol Royal Hospital for Children
Bristol , Bristol, City of
Cambridge Clinical Research Facility
Cambridge , Cambridgeshire
Alder Hey Children's Hospital
Liverpool , England
Great Ormond Street Hospital For Children NHS Foundation Trust
London
Royal Victoria Infirmary
Newcastle upon Tyne , England
Sheffield Children's Hospital
Sheffield
University Hospital Southampton NHS Foundation Trust
Southampton , Hampshire
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
16.10.2019
Completion date
01.07.2028
Registry ID
NCT04088409
Source
clinicaltrials.gov
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