EUCTR2019-002366-12-GB进行中（未招募）1 期
ADalimumab Vs. conventional ImmunoSupprEssion for uveitis(ADVISE)Trial - ADVISE - Protocol version 1.0 19 Dec 2018
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 222
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age 13 years or older
- •2.Active or recently active (= 60 days) non-infectious, intermediate, posterior, or panuveitis
- •3.Prednisone indication meets one of the following:
- •a.Active uveitis requiring one of the following
- •i.Initiation of prednisone at dose greater than 7.5 mg/day
- •ii.Increasing prednisone dose to greater than 7.5 mg/day
- •iii.Currently receiving dose greater than 7.5 mg/day
- •b.Inactive uveitis on current dose greater 7.5 mg/day
- •4.Initiation or addition of an immunosuppressive drug (i.e., a conventional immunosuppressive drug or adalimumab) is indicated
- •5.If currently receiving a conventional immunosuppressive drug, the drug and dose have been stable for at least 30 days
- •6.Patient able and willing to self-administer subcutaneous injections or have a qualified person available to administer subcutaneous injections
- •7.If posterior segment disease is present, ability to assess activity in at least one eye with uveitis
- •8.Visual acuity of light perception or better in at least one eye with uveitis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1.Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-? release assay [IGRA] test, such as Quantiferon-gold)
- •2.Untreated active hepatitis B or C infection
- •3.Behçet disease
- •4.Multiple sclerosis
- •5.For patients with intermediate uveitis, abnormal magnetic resonance imaging (MRI) of the brain consistent with demyelinating disease
- •6.Use of anti-TNF monoclonal antibody therapy within past 60 days
- •7.History of adalimumab intolerance or ineffectiveness
- •8.Current treatment with an alkylating agent
- •9.Current treatment with more than one immunosuppressive drug, not including oral corticosteroids
- •10.Shorter-acting regional corticosteroids administered within the past 30 days in any eye(s) with uveitis
- •11.Long-acting ocular corticosteroid implants, i.e., fluocinolone acetonide implant (e.g., Retisert®, YutiqTM, Iluvien®) placed within past 3 years unless uveitis is active in all eye(s) with an implant
- •12.Systemic disease that is sufficiently active such that it dictates therapy with systemic corticosteroids or immunosuppressive agents at the time of enrollment
- •13.Immunodeficiency disease for which immunosuppressive therapy would be contraindicated according to best medical judgment
- •14.Pregnancy, lactation, or for women of child-bearing potential unwillingness to use appropriate birth control for the duration of the trial
- •15.Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures.
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