Clinical Trial: Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and

Brief Summary: This study aims at evaluating real life effectiveness of originator adalimumab (Humira®) participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU) despite high-dose corticosteroid therapy; including effect on ocular inflammation, health-related quality of life, health resource utilization, work ability and medication burden, as well as describe the characteristics of NIIPPU participants treated with Humira® in the real-life setting.

Detailed Summary:
Sponsor: AbbVie

Current Primary Outcome: Proportion of participants who achieve treatment response at any of the follow-up visits [ Time Frame: Up to Month 12 ]

Definition of response: "quiescence" defined as patients with no new active chorioretinal inflammatory lesions and having anterior chamber (AC) cell and vitreous haze (VH) grade of <=0.5+ in both eyes.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of participants with treatment response separately for each follow-up visit [ Time Frame: Up to Month 12 ]
    Response is defined as participants with no new active inflammatory lesions and having anterior chamber (AC) cell and vitreous haze (VH) grade of <=0.5+ in both eyes.
  • Proportion of participants with flare at any of follow up visit [ Time Frame: Up to Month 12 ]
    Flare is defined as new active inflammatory lesions or AC cell grade of >=2+ or VH grade of >=2+ at least in one eye.
  • Proportion of participants with maintained response separately for each follow-up visit [ Time Frame: Up to Month 12 ]
    Maintained response is defined as quiescence achieved at respective prior visit and no flare at current visit.
  • Proportion of participants with maintained response at any of follow up visits [ Time Frame: Up to Month 12 ]
    Maintained response is defined as quiescence achieved at respective prior visit and no flare at current visit.
  • Changes in total score of Work Productivity & Activity Impairment (WPAI)-UV score [ Time Frame: From Month 1 to Month 12 ]
    Assessing changes in total score of WPAI-UV score
  • Percent change in Presenteeism [ Time Frame: Up to Month 12 ]
    Assessing percent change in presenteeism
  • Percent change in Absenteeism [ Time Frame: Up to Month 12 ]
    Assessing percent change in absenteeism
  • Percent Change in Total work productivity impairment [ Time Frame: Up to Month 12 ]
    Assessing Percent Change in Total work productivity impairment
  • Percent Change in Total activity impairment [ Time Frame: Up to Month 12 ]
    Assessing Percent Change in Total activity impairment
  • Change in cumulative hospital admissions [ Time Frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months) ]
    Assessing change in cumulative hospital admissions
  • Change in emergency room admissions [ Time Frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months) ]
    Assessing change in emergency room admissions
  • Change in outpatient visits [ Time Frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months) ]
    Assessing change in outpatient visits
  • Change in hospitalization days prior to and during Humira® treatment [ Time Frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months) ]
    Assessing change in hospitalization days prior to and during Humira® treatment
  • Change from baseline in Central Retinal Thickness (CRT) [ Time Frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months) ]
    Assessing change from baseline in Central Retinal Thickness (CRT)
  • Change from baseline in Best corrected visual acuity (BCVA) [ Time Frame: From Month 1 to Month 12 ]
    Assessing change from baseline in Best corrected visual acuity (BCVA)
  • Change from baseline in intraocular pressure [ Time Frame: From Month 1 to Month 12 ]
    Assessing change from baseline in intraocular pressure


Original Secondary Outcome: Same as current

Information By: AbbVie

Dates:
Date Received: May 15, 2017
Date Started: May 19, 2017
Date Completion: May 2, 2019
Last Updated: May 15, 2017
Last Verified: May 2017