Clinical Trial: A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multicenter Open-Label Study of the Long-term Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Non-infectious Intermediate-, Posterior-, or

  • Evaluation of Adverse Events [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Significant laboratory value changes [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Significant vital sign changes [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks) ]


    • Original Primary Outcome:

    • Evaluation of Adverse Events [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 78 weeks) ]
    • Significant laboratory value changes [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 78 weeks) ]
    • Significant vital sign changes [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 78 weeks) ]


    Current Secondary Outcome:

    • Proportion of subjects at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
    • Proportion of subjects at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
    • Proportion of subjects at each study time point with a Grade <= 0.5+ in AC cells in both eyes on Slit Lamp Exam according to SUN criteria. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
    • Proportion of subjects at each study time point with a Grade <= 0.5+ in vitreous haze in both eyes on indirect ophthalmoscopy according to NEI/SUN criteria. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
    • Proportion of subjects at each study time point without a worsening of BCVA by >= 15 letters on the ETDRS in both eyes relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
    • Proportion of subjects at each study time point without a worsening of BCVA by >= 15 letters on the ETDRS in both eyes relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
    • Percent change in central retinal thickness (1 mm subfield) in each eye at each study time point relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks) ]
    • Percent change in central retinal thickness (1 mm subfield) in each eye at each study time point relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Week 8 to Final Visit (Final Visit could occur at any point up to 330 weeks) ]
    • Change in NEI Visual Functioning Questionnaire (VFQ-25) score at each study time point relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks) ]
    • Change in NEI Visual Functioning Questionnaire (VFQ-25) score at each study time point relative to week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Week 8 to Final Visit (Final Visit could occur at any point up to 330 weeks) ]
    • Proportion of subjects at each study time point achieving a >= 50% reduction in immunosuppression load relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 282 weeks) ]
    • Proportion of subjects at each study time point achieving a >= 50% reduction in immunosuppression load relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]


    Original Secondary Outcome:

    • Proportion of subjects with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur any time up to 78 weeks) ]
    • Proportion of subjects with a Grade =< 0.5+ in AC cells in both eyes on Slit Lamp Exam according to SUN criteria. [ Time Frame: Final Visit (Final Visit could occur any time up to 78 weeks) ]
    • Proportion of subjects with a Grade =< 0.5+ in vitreous haze in both eyes on indirect ophthalmoscopy according to NEI/SUN criteria. [ Time Frame: Final Visit (Final Visit could occur at any point up to 78 weeks) ]
    • Proportion of subjects without a worsening of BCVA by >= 3 lines or 15 letters on the ETDRS in both eyes relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur any time up to 78 weeks) ]
    • Change in central retinal thickness (1 mm subfield) in each eye at each study time point relative to Baseline for subjects who had inactive uveitis when they entered the study [ Time Frame: Baseline to Final Visit (Final Visit could occur any time up to 78 weeks) ]
    • Change in NEI Visual Functioning Questionnaire (VFQ-25) score relative to Baseline for subjects who had inactive uveitis when they entered the study [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 78 weeks) ]
    • Proportion of subjects achieving a >= 50% reduction in immunosuppression load relative to Baseline for subjects who had inactive uveitis when they entered the study [ Time Frame: Final Visit (Final Visit could occur at any point up to 78 weeks) ]
    • Proportion of subjects with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Final visit Final Visit (Final Visit could occur at any point up to 78 weeks) ]
    • Proportion of subjects without a worsening of BCVA by >= 3 lines or 15 letters on the ETDRS in both eyes relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Final Visit Final Visit (Final Visit could occur at any point up to 78 weeks) ]
    • Change in central retinal thickness (1 mm subfield) in each eye at each study time point relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Week 8 to Final Visit Final Visit (Final Visit could occur at any point up to 78 weeks) ]
    • Proportion of subjects achieving a >=50% reduction in immunosuppression load relative to Week 8 for subjects who had active uveitis when they entered the study [ Time Frame: Final Visit (Final Visit could occur any time up to 78 weeks) ]
    • Change in NEI Visual Functioning Questionnaire (VFQ-25) score relative to Baseline for subjects who had active uveitis when they entered the study [ Time Frame: Week 8 to Final Visit (Final Visit could occur at any point up to 78 weeks) ]


    Information By: AbbVie

    Dates:
    Date Received: May 14, 2010
    Date Started: November 23, 2010
    Date Completion: May 10, 2018
    Last Updated: April 19, 2017
    Last Verified: April 2017