Skip to content

Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis (JAKUVEITE)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513802-77-00
Acronym
2020/420/HP
Enrollment
33
Registered
2024-05-28
Start date
2023-08-30
Completion date
2024-12-26
Last updated
2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active non-anterior non-infectious uveitis

Brief summary

Partial remission at 6 months. In case of bilateral involvement, the eye with the most severe involvement will be the eye chosen for the study.

Detailed description

Partial remission at 1 month, 3 months of treatment, according to the same parameters as defined for the primary endpoint., Median change in visual acuity (LogMAR) at 1 month, 3 months and 6 months of treatment compared to baseline ophthalmologic assessment, Slit-lamp measurement of median change in anterior chamber inflammation according to the Tyndall, SUN (1) scale at 1 month, 3 months and 6 months of treatment compared to baseline ophthalmologic assessment, Slit-lamp measurement of median change in vitreous inflammation according to the vitreous haze (SUN [1]) at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmologic evaluation., Fluorescein angiographic analysis of vasculitis lesions at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmologic evaluation, Optical coherence tomography measurement of median change in central macular thickness at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmologic evaluation., Measurement of the number of patients with correction of cystoid macular edema measured by optical coherence tomography (cystoid macular thickness <300 μm and disappearance of intraretinal logettes) at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmologic assessment, Measurement of median change in corticosteroid dosages at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmologic evaluation, EvI and EvIG on baricitinib from initiation of treatment through 6 months of follow-up.

Interventions

DRUGcomprimé sécable
DRUGFLUORESCEINE SODIQUE FAURE 10 POUR CENT
DRUGsolution injectable

Sponsors

Centre Hospitalier Universitaire Rouen, Centre Hospitalier Universitaire Rouen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Partial remission at 6 months. In case of bilateral involvement, the eye with the most severe involvement will be the eye chosen for the study.

Secondary

MeasureTime frame
Partial remission at 1 month, 3 months of treatment, according to the same parameters as defined for the primary endpoint., Median change in visual acuity (LogMAR) at 1 month, 3 months and 6 months of treatment compared to baseline ophthalmologic assessment, Slit-lamp measurement of median change in anterior chamber inflammation according to the Tyndall, SUN (1) scale at 1 month, 3 months and 6 months of treatment compared to baseline ophthalmologic assessment, Slit-lamp measurement of median change in vitreous inflammation according to the vitreous haze (SUN [1]) at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmologic evaluation., Fluorescein angiographic analysis of vasculitis lesions at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmologic evaluation, Optical coherence tomography measurement of median change in central macular thickness at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmo

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026