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

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 2

Conditions: Uveitis

Treatments: Drug: Adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00525902

e2434

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Adalimumab

Experimental group

Treatment:

Drug: Adalimumab