“Randomized controlled multicenter study comparing efficacy and safety of adalimumab to that of mycophenolate mofetil in steroid dependent non-infectious uveitis” - FOCUS

Ki vehet részt

• The eligibility criteria will be checked at the screening visit (which takes place four weeks maximum prior to inclusion visit) and at the inclusion/randomization visit. Adult patients meeting the following criteria may be included in the study: 1. Provide written, informed consent prior to the performance of any study specific procedures
• ≥18 years of age
• Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature [SUN] criteria) of intermediate, posterior, or pan- uveitis confirmed by documented medical history
• Recent activity of NIU as defined by the presence of at least 1 of the following parameters in either eye within the 3 months prior to inclusion visit despite >7mg/day of oral prednisone: a) Active chorioretinal or retinal vascular lesion b) Presence of macular edema by optical coherence. c) ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria) d) ≥ 2+ vitreous haze (National Eye Institute [NEI]/SUN criteria)
• Chest X-ray or CT-scanner results within 12 weeks prior to inclusion with no evidence of active Tuberculosis, active infection, or malignancy
• A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) obtained within 12 weeks prior to inclusion is eligible if: a. Her/his chest X-ray does not show evidence suggestive of active TB disease b. And there are no clinical signs and symptoms of pulmonary and/or extra-pulmonary TB disease. c. And these subjects with a latent TB infection who have not already received a prophylactic TB treatment must agree in advance to complete such a treatment course
• For female subjects of child-bearing potential: a negative pregnancy test at inclusion
• For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject’s partner from becoming pregnant during the study and 3 months and 5 months after stopping therapy for MMF and adalimumab, respectively, unless sterility is confirmed. The simultaneous use of two complementary methods of contraception is preferable. Methods which may be considered as highly effective methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods (according to CTFG recommendations). Such methods include: For Female subjects : a. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1: ▪ oral ▪ intravaginal ▪ transdermal b. progestogen-only hormonal contraception associated with inhibition of ovulation: ▪ oral ▪ injectable ▪ implantable c. intrauterine device (IUD) d. intrauterine hormone-releasing system (IUS) e. bilateral tubal occlusion f. vasectomised partner g. sexual abstinence (In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject). For male subjects : a. use of condoms b. vasectomy (with documentation of azoospermia) c. sexual abstinence
• Affiliated to a social security system

Ki nem vehet részt

• Use of the following systemic treatments during the specified periods: • Treatment with any systemic alkylating agents within 12 months prior to inclusion (e.g., cyclophosphamide, chlorambucil) • Any live (attenuated) vaccine within 4 weeks prior to inclusion
• Participation in another interventional study involving human participants or in the exclusion period at the end of a previous study involving human participants, if applicable
• Infection requiring treatment with intravenous antibiotics within 3 weeks prior to inclusion
• Subjects will not be included in the study if they meet any of the following criteria: 1. Infectious uveitis, masquerade syndromes (idiopathic uveitis is permitted)
• Stage III and IV New York Heart Association (NYHA) cardiac insufficiency
• Active tuberculosis
• Positive HIV serology or HCV HBs Ag test
• History of malignancy within 5 years prior to Inclusion other than carcinoma in situ of the cervix, non-metastatic squamous or basal cell carcinoma of the skin
• History of severe allergic or anaphylactic reactions to monoclonal antibodies, mycophenolate mofetil, rifampicin, isoniazid or fluorescein
• History of multiple sclerosis and/or demyelinating disorder
• Laboratory values assessed during inclusion: • Hemoglobin < 8g/dL • WBC < 2.0 x 103/mm3 • Platelet count < 80 x 103/mm3 • Glomerular filtration rates (GFR) <30ml/min. • Transaminases > 3 times upper normal value
• Pregnancy or breastfeeding
• Under legal protection
• Isolated anterior uveitis
• Monophtalmic patient