Adalimumab vs. Conventional Immunosuppression for Uveitis Trial

Completed · Phase 3

Conditions studied: Uveitis

In brief

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-tumor necrosis(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.

Key facts

Study ID

NCT03828019

Run by

JHSPH Center for Clinical Trials

People needed

227

Starts

2019-09-16

Expected to finish

2024-09-09

Last updated by the study team

2025-05-16

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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
• 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®, Yutiq™, 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

Where it is running

• Jules Stein Eye Institute, UCLA — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• National Eye Institute — Bethesda, Maryland, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• University of Michigan Health System, Kellogg Eye Center — Ann Arbor, Michigan, United States
• Washington University — St Louis, Missouri, United States
• MidAtlantic Retina, Wills Eye Hospital — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Tennessee Retina — Nashville, Tennessee, United States
• Vanderbilt University Eye Institute — Nashville, Tennessee, United States
• Retinal Consultants of Texas — Bellaire, Texas, United States
• University of Utah, Moran Eye Center — Salt Lake City, Utah, United States
• University of Washington, Medicine Eye Institute — Seattle, Washington, United States
• Centre for Eye Research Australia — East Melbourne, Victoria, Australia
• University of Sydney — Sydney, Australia
• University Hospital Birmingham — Edgbaston, Birmingham, United Kingdom
• Bradford Teaching Hospital NHS Foundation Trust — Bradford, United Kingdom
• Cambridge University NHS Trust — Cambridge, United Kingdom
• University Hospitals of Leicester — Leicester, United Kingdom

Full record on ClinicalTrials.gov

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