Adalimumab vs. Conventional Immunosuppression for Uveitis Trial

Ki vehet részt

• Age 13 years or older
• Weight 30 kg (66 lbs) or greater
• Active or recently active (≤ 60 days) non-infectious intermediate, posterior, or panuveitis
• Prednisone indication meets one of the following:; 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; Inactive uveitis on current dose greater 7.5 mg/day
• Initiation or addition of an immunosuppressive drug (i.e., a conventional immunosuppressive drug or adalimumab) is indicated
• If currently receiving a conventional immunosuppressive drug, the drug and dose have been stable for at least 30 days
• Patient able and willing to self-administer subcutaneous injections or have a qualified person available to administer subcutaneous injections
• If posterior segment disease is present, ability to assess activity in at least one eye with uveitis
• Visual acuity of light perception or better in at least one eye with uveitis

Ki nem vehet részt

• Receipt of a live vaccine within past 30 days
• Use of anti-TNF monoclonal antibody therapy within past 60 days
• Current treatment with an alkylating agent
• Current treatment with more than one immunosuppressive drug, not including oral corticosteroids
• Shorter-acting regional corticosteroids administered within the past 30 days in any eye(s) with uveitis
• Long-acting ocular corticosteroid implants, i.e., fluocinolone acetonide implant (e.g., Retisert®, Yutiq™, Iluvien®) placed within past 3 years unless uveitis is active in all eye(s) with an implant
• For persons of child-bearing potential or impregnating potential, unwillingness to use appropriate birth control (abstinence, combination barrier and spermicide, hormonal, or intrauterine device) for the next 18 months or plans to become a biological parent within the next 18 months; In the United Kingdom (UK), use of combination barrier and spermicide alone does not meet birth control requirements; † UK female study participants must use highly effective methods of contraception; UK male study participants must use condoms for at least 6 months after the end of study treatment and their female partners of child-bearing potential are recommended to use highly effective contraception for the same duration. In addition, male participants should not donate semen during therapy or for 6 months following discontinuation of study treatment
• Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures
• Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-γ release assay [Interferon-gamma release assay (IGRA) test, such as Quantiferon-gold)
• Untreated active hepatitis B or C infection
• Behçet disease
• Multiple sclerosis or other demyelinating disease
• For patients with anterior/intermediate or intermediate uveitis without systemic disease, abnormal magnetic resonance imaging (MRI) of the brain consistent with demyelinating disease
• Severe uncontrolled infection
• Moderate to severe heart failure (NYHA class III/IV)
• Active malignancy
• History of adalimumab intolerance or ineffectiveness
• Hypersensitivity to any of the study treatments or their excipients
• Systemic disease that is sufficiently active such that it dictates therapy with systemic corticosteroids or immunosuppressive agents at the time of enrollment
• Immunodeficiency disease for which immunosuppressive therapy would be contraindicated according to best medical judgment
• Any of the following baseline lab values; White blood count <3500 cells per microliter; Platelets <100,000 per microliter; Hematocrit <30%; aspartate aminotransferase (AST) or alanine transaminase (ALT) >1.5 times (X) upper limit normal value; Serum creatinine >1.1 times (X) upper limit normal value
• Pregnancy or lactation