Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis

Phase 2CompletedNCT00525902

Oregon Health and Science University31 enrolled

Overview

The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uveitis

Interventions

AdalimumabDRUG

40 mg delivered every 2 weeks by subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with vision-threatening autoimmune uveitis. 2. Failure to respond to prednisone and at least one other systemic immunosuppressive (such as methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, cyclophosphamide, or chlorambucil), or intolerance to such medications due to side effects. Exclusion Criteria: 1. Serious concomitant illness that could interfere with the subject's participation in the trial. 2. Previous or current use of cyclophosphamide. 3. Unable or unwilling to undergo multiple injections.

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Cumulative Endpoint

Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.

Time frame: 10 weeks

Cumulative Endpoint

Time frame: 50 Weeks

Data from ClinicalTrials.gov

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