Clinical Trial: Rituximab in the Treatment of Scleritis and Non-Infectious Orbital Inflammation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A PhaseI/II Prospective, Randomized, Dose-Ranging Pilot Study of Rituximab in the Treatment of Refractory Scleritis and Non-Infectious Orbital Inflammation

Brief Summary: The purpose of this study is to assess the safety and tolerability of Rituximab in refractory scleritis and non-infectious orbital inflammation.

Detailed Summary:
Sponsor: Oregon Health and Science University

Current Primary Outcome:

• Reduction of Medications [ Time Frame: 24 Weeks ]
  Reduction (decrease in dosage) of systemic corticosteroids or immunosuppressive therapy by at least 50% by 24 weeks.
• Improved Control of Inflammation [ Time Frame: 24 weeks ]

  For patients with scleritis, disease activity as measured by a modified grading system first described by McCluskey et al. (McCluskey and Wakefield 1987; McCluskey and Wakefield 1991). Improvement in scleritis activity will be defined as a reduction in this grading score of 2 or more, or an overall score of 4 or less by 24 weeks.

  For patients with orbital inflammation, disease activity as measured by a modified grading system first devised by Werner (Werner 1977). Improvement in orbital inflammation will be defined as a reduction in this grading score of 2 or more, or an overall score of 3 or less.

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Oregon Health and Science University

Dates:
Date Received: December 21, 2006
Date Started: January 2007
Date Completion:
Last Updated: August 8, 2013
Last Verified: August 2013