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Adalimumab vs. Conventional Immunosuppression for Uveitis Trial

NCT03828019 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2025-05-16

Study results available
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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-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.

Conditions

  • Uveitis

Interventions

BIOLOGICAL

Adalimumab (ADA)

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.

DRUG

Conventional immunosuppression (CON)

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.

Sponsors & Collaborators

  • JHSPH Center for Clinical Trials

    lead OTHER

Principal Investigators

  • Douglas A Jabs, MD MBA · CCTand Evidence Synthesis, JHU, Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2024-04-02
Completion
2024-09-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03828019 on ClinicalTrials.gov