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

Launched by UNIVERSITY HOSPITAL, ROUEN · Dec 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Baricitinib, which is designed to help treat a specific eye condition known as non-anterior non-infectious uveitis that has not responded to previous treatments. Uveitis is an inflammation of the eye that can lead to vision problems. This study aims to see if Baricitinib is effective and safe for patients who have tried at least one other type of therapy without success. The trial is still in the planning stages and has not started recruiting participants yet.

To be eligible for this study, participants need to have a diagnosis of non-anterior non-infectious uveitis and must have stopped other treatments, like certain immunosuppressive drugs, for at least 10 days before joining. Patients will be closely monitored during the trial to assess how well the medication works and to check for any side effects. It's important to note that not everyone will qualify; for example, individuals with certain types of uveitis or specific health conditions may be excluded. If you or a family member are interested in participating, it would be best to discuss it further with a healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient with diagnosis of non-anterior non-infectious uveitis, refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab)
• • Need to stop biotherapy (anti-TNF alpha or tocilizumab) and conventional immunosuppressive drugs (mycofenolate mofetil, methotrexate, azathioprine, cyclosporine, interferon alpha 2a) for at least 10 days prior to the inclusion date
• Exclusion Criteria:
• • 1. Isolated anterior uveitis. 2. Infectious uveitis. 3. Severe uveitis threatening the visual prognosis and requiring emergency treatment with intravenous corticosteroids.
• • 4. Initial visual acuity \> 1.3 LogMAR in at least one eye. 5. Corneal or lens opacity that prevents fundus visualization or may require cataract surgery during the study.
• • 6. Contraindication to baricitinib (OLUMIANT 2 and 4 mg film-coated tablets) : Hypersensitivity to the active substance or to any of the excipients.
• • 7. Contraindication to mydriasis. 8. Refractory glaucoma in either eye. 9. Monophthalmic patient. 10. Previous treatment with JAK inhibitors. 11. Intraocular corticosteroid injection (subconjunctival or laterobulbar) within 1 month prior to inclusion or intravitreal corticosteroid implant within 3 months prior to inclusion.
• • 12. Need for treatment with a biotherapy (anti-IL6, anti-IL6 receptor, anti-IL1, anti-IL12/IL23 anti-IL17, anti-BAFF) for extra-ocular involvement, during the entire study period.
• • 13. Treatment with OAT3 inhibitors with high inhibitory potential such as probenecid, leflunomide, teriflunomide 14. 14. Vaccination with a live or live attenuated vaccine within 15 days prior to inclusion 15. History of cancer within the previous 5 years, except non-metastatic squamous cell and basal cell carcinoma of the skin.
• • 16. Personal history of venous thromboembolic disease.