Adalimumab vs. Conventional Immunosuppression for Uveitis Trial

Part of paid clinical trials in Los Angeles, California.

Sponsor
JHSPH Center for Clinical Trials
Study ID
NCT03828019
Phase
PHASE3
Status
Completed

Conditions

  • Uveitis

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab (ADA) — BIOLOGICAL
    Adalimumab is a fully-human monoclonal antibody to TNF-α, which is approved by the U.S. FDA for the treatment of non-infectious intermediate, posterior, and panuveitides in adults and children 2 years of age and older.
  • Conventional immunosuppression (CON) — DRUG
    The study ophthalmologist will select amongst the permissible drugs (methotrexate, mycophenolate mofetil or azathioprine for antimetabolites; cyclosporine or tacrolimus for calcineurin inhibitors) taking into account the side effect profile of each drug with respect to subject's clinical situation.

Study Details

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 Dates

Start date
Sep 16, 2019
Status verified
Apr 2025
Primary completion
Apr 2, 2024
Completion
Sep 9, 2024

Study Design

Enrollment
227 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Adalimumab (ADA)
    Adalimumab administered by subcutaneous injection at dosage and frequency specified below; total duration of treatment is 12 months. Adults (≥ 18 years of age) and adolescents ≥30 kg: 80 mg as initial dose; one week later by 40 mg then 40 mg every two weeks. Adolescents \<30 kg: 40 mg as initial dose; one week later 20 mg then 20 mg every 2 weeks.
  • Active Comparator: Conventional immunosuppression (CON)
    Conventional immunosuppressive agent selected by study ophthalmologist at dose and frequency specified below;12 month treatment duration. Azathioprine: initially 2 mg/kg/day; max dose 200 mg/day. Methotrexate initially 15mg/wk; max dose 25 mg/wk. Mycophenolate initially 1 gm twice daily (BID); max dose1.5 gm BID. Cyclosporine (Sandimmune - dose 2.5 mg/kg BID and Neoral dose 2 mg/kg BID. Tacrolimus initially 1 mg BID; max dose 3 mg BID.

Primary Outcome Measure

Corticosteroid-sparing Treatment Success Within the First 6 Months After Randomization [ Time Frame: 6 months ]

Locations (19)

FacilityCityStateZIPSite coordinators
Jules Stein Eye Institute, UCLALos AngelesCalifornia90095-
University of California, San FranciscoSan FranciscoCalifornia94143-
Anne Bates Leach Eye Hospital, University of Miami Miller School of MedicineMiamiFlorida33136-
Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
University of IowaIowa CityIowa52242-
Johns Hopkins UniversityBaltimoreMaryland21287-
National Eye InstituteBethesdaMaryland20892-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
University of Michigan Health System, Kellogg Eye CenterAnn ArborMichigan48105-
Washington UniversitySt LouisMissouri63110-
MidAtlantic Retina, Wills Eye HospitalPhiladelphiaPennsylvania19107-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Tennessee RetinaNashvilleTennessee37203-
Vanderbilt University Eye InstituteNashvilleTennessee37232-
Retinal Consultants of TexasBellaireTexas77401-
University of Utah, Moran Eye CenterSalt Lake CityUtah84132-
University of Washington, Medicine Eye InstituteSeattleWashington98104-

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By research site
Jules Stein Eye Institute, UCLA· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAAnne Bates Leach Eye Hospital, University of Miami Miller School of Medicine· Miami, FLEmory University· Atlanta, GANorthwestern University· Chicago, ILRush University Medical Center· Chicago, IL

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