An observational study in Uveitis, sponsored by AbbVie. Completed at 28 sites in 12 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by AbbVie · Observational
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.
Participants with diagnosed active non- infectious intermediate, posterior or panuveitis (NIIPPU) that are being treated with Humira® as per locally approved label and prescription guidelines.
Diagnosis of active NIIPP uveitis as defined by the presence of at least 1 of the following parameters:
Exclusion Criteria:
Participants with active non- infectious intermediate, posterior or panuveitis receiving adalimumab (Humira®).
Proportion of participants who achieve treatment response at any of the follow-up visits
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.
Time frame: Up to Month 12
Proportion of participants with maintained response at any of follow up visits
Maintained response is defined as quiescence achieved at respective prior visit and no flare at current visit.
Time frame: Up to Month 12
Percent change in Presenteeism
Assessing percent change in presenteeism
Time frame: Up to Month 12
Proportion of participants with maintained response separately for each follow-up visit
Maintained response is defined as quiescence achieved at respective prior visit and no flare at current visit.
Time frame: Up to Month 12
Percent Change in Total activity impairment
Assessing Percent Change in Total activity impairment
Time frame: Up to Month 12
Changes in total score of Work Productivity & Activity Impairment (WPAI)-UV score
Assessing changes in total score of WPAI-UV score
Time frame: From Month 1 to Month 12
Change in emergency room admissions
Assessing 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)
Proportion of participants with treatment response separately for each follow-up visit
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.
Time frame: Up to Month 12
Change from baseline in Best corrected visual acuity (BCVA)
Assessing change from baseline in Best corrected visual acuity (BCVA)
Time frame: From Month 1 to Month 12
Change in cumulative hospital admissions
Assessing 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)
Change from baseline in Central Retinal Thickness (CRT)
Assessing 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)
Proportion of participants with flare at any of follow up visit
Flare is defined as new active inflammatory lesions or AC cell grade of \>=2+ or VH grade of \>=2+ at least in one eye.
Time frame: Up to Month 12
Percent change in Absenteeism
Assessing percent change in absenteeism
Time frame: Up to Month 12
Percent Change in Total work productivity impairment
Assessing Percent Change in Total work productivity impairment
Time frame: Up to Month 12
Change in outpatient visits
Assessing 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)
Change in hospitalization days prior to and during Humira® treatment
Assessing 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)
Change from baseline in intraocular pressure
Assessing change from baseline in intraocular pressure
Time frame: From Month 1 to Month 12
Plan to share: Undecided
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AbbVie