Uveitis in Behcet’s Disease
Conditions
Interventions
Arm A: Interferon Alpha-2a
Arm B:Adalimumab
Arm C:Cyclosporine
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a.Age = 18 years. b.Diagnosed with Behcets disease.(According to The International Criteria for Behcet's Disease (ICBD)) c.Current use of oral prednisone (= 20 mg or equivalent) for the treatment for intraocular inflammation and/or having an active inflammation within the last 90 days as defined by the presence of at least one of the following parameters in either eye: ·= 2+ anterior chamber cells ·= 2+ vitreous haze ·Active retinal vascular lesion ·Presence of macular edema by OCT or FFA d.Able and willing to self-administer subcutaneous injections. e.Able and willing to implement effective contraception. f.Able and willing to provide written informed consent. g.Able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
Exclusion criteria: a.Previous exposure to anti-TNF therapy, Interferon Alpha-2a and any biologic therapy. b.Any conditions that can impede the proper view of the posterior segment. c.Glaucoma or glaucomatous optic nerve injury. d.Intravitreal corticosteroid injection in the past 3 months. e.Glucocorticosteroid implant. f.Ocular surgery within 30 days prior to the Screening. g.Diabetic retinopathy. h.Neovascular/wet age-related macular degeneration i.White blood cells 1200 ×109/L at the Screening. k.Hemoglobin < 8 g/dL at the Screening. l.Abnormal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 2 times the upper limit of normal for the lab at the Screening. m.Abnormal serum creatinine = 2 times the upper limit of normal for the lab at the Screening. n.History of malignancy. o.Evidence of active tuberculosis, HIV infection, syphilis, or hepatitis B or C. p.Recurrent infections (including but not limited to herpes zoster, histoplasmosis, coccidiomycosis, but excluding onychomycosis). q.Any other condition which, in the opinion of the Investigator, would put the subject at risk by participation in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The annualized relapse rate (ARR) of uveitis in Behcet’s disease; | — |
Countries
China
Contacts
Public ContactPeizeng Yang
Outcome results
None listed