Behçet’s uveitis
Conditions
Interventions
A group:Usual immunosuppressive therapy plus Adalimumab
B group:Usual immunosuppressive therapy plus low-dose IL-2
C group:Usual immunosuppressive therapy plus Adalimumab plus low-dose IL-2
D group:Usual immunosuppressive therapy
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria A subject will be eligible for study participation if she/he meets all of the following inclusion criteria: a.Subjects of either sex aged = 18 years at the time of signing the informed consent document. b.Diagnosed with Behçet’s disease. See The International Criteria for Behçet's Disease (ICBD) in Appendix I. c.Classified as Behçet’s disease uveitis. See Standardization of Uveitis Nomenclature (SUN) Working Group Criteria in Appendix II. d.Using systemic corticosteroids and one noncorticosteroid, non-biologic systemic immunosuppressive agent according to current guidelines. e.Using oral prednisone at a baseline dose of =35 mg/day (or oral corticosteroid equivalent) that have not been increased in the past 4 weeks or decreased in the past 2 weeks f.Using one noncorticosteroid systemic immunosuppressive agent on a stable dose for at least 8 weeks. g.Media clarity, pupillary dilatation and subject cooperation judged by the study Investigator for proper viewing of the posterior segment of the eye. h.Able and willing to consistently use effective contraceptive methods in order to successfully prevent pregnancy. i.Able and willing to comply with all of the requirements and visits in the protocol.
Exclusion criteria
Exclusion criteria: Exclusion Criteria The presence of any of the following will exclude a subject from the study enrollment: a.Visual acuity of hand motions or worse in the better-seeing eye. b.Receiving anti-TNF therapy or low-dose IL-2 in the past 6 months. c.Receiving intraocular or periocular corticosteroids in the past 3 months, or Ozurdex® (dexamethasone implant) in the past 6 months, or Retisert® (glucocorticosteroid implant) in the past 3 years. d.The dose of immunosuppressive agent not used within the following allowable doses: Methotrexate = 7.5 and = 25 mg per week Cyclosporine = 2 and = 5 mg/kg per day Mycophenolate mofetil = 0.5 and = 3 g per day Azathioprine = 1 and = 2.5 mg/kg per day Chlorambucil = 0.05 and = 2 mg per day e.Uncontrolled intraocular pressure with = 2 glaucoma medications or evidence of optic nerve injury. f.Malignancy. g.Abnormal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 2 times the upper limit of normal for the lab at the Screening. h.Abnormal serum creatinine = 2 times the upper limit of normal for the lab at the Screening. i.Active infections based on laboratory data and clinical judgment by the study Investigator (including but not limited to tuberculosis, HIV infection, syphilis, hepatitis B or C, herpes zoster, histoplasmosis, coccidiomycosis, but excluding onychomycosis). j.Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures. k.Pregnancy or current breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the time to treatment failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to two-step increase in anterior chamber cell grade relative to the best state achieved throughout the study period or increase from grade 3+ to 4+;Time to two-step increase in vitreous haze grade relative to the best state achieved throughout the study period or increase from grade 3+ to 4+;Time to worsening of BCVA by 10 letters or more relative to best state achieved;Time to worsening of BCVA by 15 letters or more relative to best state achieved;Time to new active, inflammatory, chorioretinal and/or retinal vascular lesions relative to the last condition;Time to OCT evidence of new macular edema relative to the last condition;Time to OCT evidence of central subfield thickness increased by =10% relative to the last condition;Time to FFA evidence of new active lesions of retinal vasculitis relative to the last condition; | — |
Countries
China
Contacts
Public ContactPeizeng Yang
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed