HUMIRA® Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis

Study Overview
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Brief Summary
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This study evaluates the long- term safety and effectiveness of adalimumab in participants with non-infectious intermediate-, posterior-, or pan-uveitis in daily practice in Japan.

Official Title
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HUMIRA® Special Investigation (Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis)

Conditions
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Uveitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis Exclusion Criteria: Participants previously treated with adalimumab

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants receiving adalimumab<br>Participants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions (ADR) | ADR is the causal relationship between adalimumab and adverse events. | Up to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Functioning Questionnaire (VFQ)-25 score | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. | From Week 0 (baseline) to Week 52 | 
| Change in Visual acuity in each eye | Visual acuity change is assessed. | From Week 0 (baseline) to Week 52 | 
| Change in Anterior Chamber (AC) cell grade (standardization of uveitis nomenclature (SUN) criteria) in each eye | Slit lamp examinations will be conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam will be used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: Grade 0 = < 1 cell Grade 0.5+ = 1 - 5 cells Grade 1+ = 6 - 15 cells Grade 2+ = 16 - 25 cells Grade 3+ = 26 - 50 cells Grade 4+ = > 50 cells. | From Week 0 (baseline) to Week 52 | 
| Percentage of Overall improvement | This is assessed by physicians. | Up to Week 52 | 
| Change in retinal lesions in each eye | The change in retinal lesion are assessed. | From Week 0 (baseline) to Week 52 | 
| Change in central retinal thickness in each eye | This is assessed by Optical Coherence Tomography (OCT) | From Week 0 (baseline) to Week 52 | 
| Change in Vitreous Haze grade in each eye | Vitreous haze will be measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI)/ SUN criteria: Grade 0: No evident vitreous haze; Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured. | From Week 0 (baseline) to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humira, Adalimumab, Non-infectious Intermediate-, Posterior-, or Pan-uveitis