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

NCT00525902 | Completed Phase 2 Results

• 1 other identifier: e2434
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uveitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Adalimumab

EXPERIMENTAL

Drug: Adalimumab

Interventions

Adalimumab DRUG

40 mg delivered every 2 weeks by subcutaneous injection

Also known as: Humira

Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Illinois at Chicago: collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Uveitis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

2 had to discontinue for methodologic reasons (pregnancy, loss to follow up wk 42), leading to their classification as failures. As a three-center study, differences between the study population are possible.

Results Point of Contact

• Title: Eric B. Suhler
• Organization: Oregon Health & Science University

suhlere@ohsu.edu

503-494-5023

Study Officials

• Eric B Suhler, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• James T Rosenbaum, MD

  Oregon Health and Science University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 6, 2007
• Study Start: January 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 11, 2012
• Results First Posted: April 9, 2012

Record last verified: 2012-04

Locations

US (1)