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Completed

NCT Number: NCT00525902

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

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

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Key information

Conditions

Uveitis Eye Diseases Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with vision-threatening autoimmune uveitis.
  • 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

  • Serious concomitant illness that could interfere with the subject's participation in the trial.
  • Previous or current use of cyclophosphamide.
  • Unable or unwilling to undergo multiple injections.

Treatment and study plan

Adalimumab

Drug

40 mg delivered every 2 weeks by subcutaneous injection

Other names: Humira

Primary outcomes

  1. Cumulative Endpoint

    Time frame: 10 weeks

    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.

  2. Cumulative Endpoint

    Time frame: 50 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • The Cleveland Clinic
  • University of Illinois at Chicago

Registry information

Official study title

An Open-label, Multicenter, Phase II Trial of Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 6, 2007
Registry last updated
Apr 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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