Open Actively Recruiting

Adalimumab vs. Conventional Immunosuppression for Uveitis Trial

About

Brief Summary

Non-infectious intermediate, posterior, and panuveitides are chronic, potentially-blinding diseases. Vision-threatening cases require long-term therapy with oral corticosteroids and immunosuppression. Based upon preliminary data, adalimumab, a fully-human, anti-TNF-α monoclonal antibody, now US FDA-approved for uveitis treatment, may be a superior corticosteroid-sparing agent than conventional immunosuppressive drugs. The ADVISE Trial is multicenter randomized, parallel-treatment, comparative effectiveness trial comparing adalimumab to conventional (small molecule) immunosuppression for corticosteroid spring in the treatment of non-infectious, intermediate, posterior, and panuveitides.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase IV

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
13 Years
Maximum Age
N/A

Inclusion criteria

  • 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

Exclusion criteria

  • Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-γ release assay [IGRA] test, such as Quantiferon-gold)
  • Untreated active hepatitis B or C infection
  • Any of the following baseline lab values
    • White blood count <3500 cells per microliter
    • Platelets <100,000 per microliter
    • Hematocrit <30%
    • AST or ALT >1.5X upper limit normal value
    • Serum creatinine >1.1X upper limit normal value
  • 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
  • Receipt of a live vaccine within past 30 days
  • Moderate to severe heart failure (NYHA class III/IV)
  • Active malignancy
  • Use of anti-TNF monoclonal antibody therapy within past 60 days
  • History of adalimumab intolerance or ineffectiveness
  • Hypersensitivity to any of the study treatments or their excipients
  • 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®, YutiqTM, Iluvien®) placed within past 3 years unless uveitis is active in all eye(s) with an implant
  • 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
  • Pregnancy or lactation
  • 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 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.

Join this Trial

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Study Stats
Protocol No.
19-000668
Category
Ophthalmology
Contact
Gary Holland
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03828019
For detailed technical eligibility, visit ClinicalTrials.gov.