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 Overview
=================
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.

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 Panuveitis in Routine Clinical Practice -HOPE

Conditions
-----------------
Uveitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants voluntarily signed a patient authorization form to use and disclose personal health information (or informed consent, where applicable). Age >= 18 years at the time of the enrollment. Diagnosis of active NIIPP uveitis as defined by the presence of at least 1 of the following parameters: Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion >= 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN) criteria] >= 2+ vitreous haze [National Eye Institute (NEI)/SUN criteria] Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines. Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study. Exclusion Criteria: Participants who cannot be treated with Humira® according to the local Humira® SmPC and/or local professional and reimbursement guidelines. Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments. Participants currently participating in other clinical research. Participants who are unwilling or unable to complete the quality of life and other patient reported questionnaires.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants receiving adalimumab (Humira®)<br>Participants with active non- infectious intermediate, posterior or panuveitis receiving adalimumab (Humira®). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to Month 12 | 
| Percent change in Presenteeism | Assessing percent change in presenteeism | 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. | Up to Month 12 | 
| Percent Change in Total activity impairment | Assessing Percent Change in Total activity impairment | 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 | From Month 1 to Month 12 | 
| Change in emergency room admissions | Assessing change in emergency room admissions | 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. | Up to Month 12 | 
| Change from baseline in Best corrected visual acuity (BCVA) | Assessing change from baseline in Best corrected visual acuity (BCVA) | From Month 1 to Month 12 | 
| Change in cumulative hospital admissions | Assessing change in cumulative hospital admissions | 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) | 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. | Up to Month 12 | 
| Percent change in Absenteeism | Assessing percent change in absenteeism | Up to Month 12 | 
| Percent Change in Total work productivity impairment | Assessing Percent Change in Total work productivity impairment | Up to Month 12 | 
| Change in outpatient visits | Assessing change in outpatient visits | 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 | 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 | From Month 1 to Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Humira®, Adalimumab, Ocular inflammation, Active non-infectious intermediate, posterior and panuveitis