Uveitis
Conditions
Keywords
Humira, Adalimumab, Non-infectious Intermediate-, Posterior-, or Pan-uveitis
Brief summary
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Participants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis
Exclusion criteria
* Participants previously treated with adalimumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse drug reactions (ADR) | Up to Week 52 | ADR is the causal relationship between adalimumab and adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual acuity in each eye | From Week 0 (baseline) to Week 52 | Visual acuity change is assessed. |
| Change in Anterior Chamber (AC) cell grade (standardization of uveitis nomenclature (SUN) criteria) in each eye | From Week 0 (baseline) to Week 52 | 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. |
| Percentage of Overall improvement | Up to Week 52 | This is assessed by physicians. |
| Change in Visual Functioning Questionnaire (VFQ)-25 score | From Week 0 (baseline) to Week 52 | 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. |
| Change in central retinal thickness in each eye | From Week 0 (baseline) to Week 52 | This is assessed by Optical Coherence Tomography (OCT) |
| Change in Vitreous Haze grade in each eye | From Week 0 (baseline) to Week 52 | 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. |
| Change in retinal lesions in each eye | From Week 0 (baseline) to Week 52 | The change in retinal lesion are assessed. |
Countries
Japan
Outcome results
None listed