Active non-anterior non-infectious uveitis MedDRA version: 22.1 Level: LLT Classification code 10066681 Term: Acute uveitis System Organ Class: 100000004853
Conditions
Interventions
Trade Name: OLUMIANT
Pharmaceutical Form: Tablet
INN or Proposed INN: baricitinib
CAS Number: 1187594-09-7
Other descriptive name: Baricitinib
Concentration unit: mg milligram(s)
Concentration type: u
Sponsors
CHU de ROUEN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of non-anterior non-infectious uveitis refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab). Refractory uveitis is defined as: a. Either active uveitis, i.e., anterior chamber inflammation >2+ [Tyndall, SUN scale (1)] and/or vitreous inflammation >2+ [Vitreous Haze, SUN scale (1)] and/or the presence of retinal vasculitis and/or the presence of cystoid macular edema (central macular thickness greater than strictly 300 µm measured by optical coherence tomography, associated with the visualization of intraretinal logettes) b. or inactive uveitis but with corticosteroid dependence = 10 mg/day for at least 3 months. 2. Need for discontinuation of biotherapy (anti-TNF alpha or tocilizumab) and conventional immunosuppressants (mycofenolate mofetil, methotrexate, azathioprine, cyclosporine, interferon alpha 2a) for at least 10 days prior to the inclusion date. 3. Patient of legal age who has read and understood the information letter and signed the consent form. 4. Patient affiliated to a social security plan. 5. Patient under 75 years of age 6. Female: a. Of childbearing age: - Using effective contraception (estrogen-progestin or intrauterine device or tubal ligation) for at least 4 weeks prior to inclusion, during treatment, and until 1 week after discontinuation of treatment And, - Presenting a negative urine pregnancy test at inclusion; b. Surgically infertile: no ovaries and/or uterus; c. Menopausal: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit). 7. A negative quantiferon less than 6 months old (6 months included) and a normal chest x-ray less than 3 months old (3 months included) or a positive quantiferon in patients with a history of previously treated latent TB according to current recommendations. 8. HIV, HCV and HBV serology with no active infection, less than 1 month old (1 month included). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
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 placement of an 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. History of cancer within the previous 5 years, except for non-metastatic squamous cell and basal cell carcinoma of the skin. 14. Personal history of venous thromboembolic disease. 15. Pregnant or parturient or breastfeeding woman or proven lack of contraception 16. Obese patient with a body mass index = 30 kg/m2 17. Hemoglobin 500,000 / mm3 19. Neutrophil count <1000 / mm3, lymphocyte count <500/mm3. 20. Renal impairment with clearance <30 ml/min. 21. Severe hepatic impairment. 22. Allergy to fluorescein 23. Person deprived of liberty by an administrative or judicial decision or person placed under safeguard of justice / sub guardianship or curatorship. 24. Patient who has participated in another drug trial within 3 months prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Baricitinib, a JAK1 and 2 inhibitor, in the management of non-infectious non-anterior uveitis refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab) after 6 months of treatment;Secondary Objective: - evaluate the rate of complete remission at 1 month and 3 months. - evaluate the evolution of visual acuity at 1 month, 3 months and 6 months. - to evaluate the evolution of ocular inflammation at 1 month, 3 months and 6 months. - evaluate the evolution of retinal vasculitis lesions at 1 month, 3 months, and 6 months. - To evaluate the evolution of macular edema at 1 month, 3 months and 6 months. - to evaluate the evolution of corticosteroid dosage at 1 month, 3 months and 6 months. - to evaluate the tolerance of the treatment;Primary end point(s): complete remission at 6 months;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Complete 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 ophthalmic 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. ;Timepoint(s) of evaluation of this end point: 1, 3 and 6 months | — |
Countries
France
Contacts
Public ContactArmelle Guidotti
CHU de Rouen
Outcome results
None listed