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

Uveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525902
• Other study ID #: e2434
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2007
• Last updated: April 6, 2012
• Start date: January 2008
• Est. completion date: September 2010

Study information

• Verified date: April 2012
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uveitis

Intervention

Drug:
• Adalimumab
40 mg delivered every 2 weeks by subcutaneous injection

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	The Cleveland Clinic, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 weeks	No
Primary	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.	50 Weeks	No