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.
Study Type
OBSERVATIONAL
Enrollment
259
Incidence of adverse drug reactions (ADR)
ADR is the causal relationship between adalimumab and adverse events.
Time frame: Up to Week 52
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.
Time frame: From Week 0 (baseline) to Week 52
Change in Visual acuity in each eye
Visual acuity change is assessed.
Time frame: 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.
Time frame: From Week 0 (baseline) to Week 52
Percentage of Overall improvement
This is assessed by physicians.
Time frame: Up to Week 52
Change in retinal lesions in each eye
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Juntendo University Urayasu Hospital /ID# 168358
Urayasu-shi, Chiba, Japan
Matsuyama Red Cross Hospital /ID# 164149
Matsuyama, Ehime, Japan
Kyushu University Hospital /ID# 163042
Fukuoka, Fukuoka, Japan
Fukuoka University Hospital /ID# 163043
Fukuoka, Fukuoka, Japan
Kurume University Hospital /ID# 162945
Kurume-shi, Fukuoka, Japan
Gunma University Hospital /ID# 166916
Maebashi, Gunma, Japan
Hiroshima University Hospital /ID# 166915
Hiroshima, Hiroshima, Japan
Hokkaido University Hospital /ID# 163041
Sapporo, Hokkaido, Japan
Kobe University Hospital /ID# 165250
Kobe, Hyōgo, Japan
Duplicate_Kanazawa University Hospital /ID# 166914
Kanazawa, Ishikawa-ken, Japan
...and 29 more locations
The change in retinal lesion are assessed.
Time frame: From Week 0 (baseline) to Week 52
Change in central retinal thickness in each eye
This is assessed by Optical Coherence Tomography (OCT)
Time frame: 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.
Time frame: From Week 0 (baseline) to Week 52