Clinical Trial: HUMIRA® Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: HUMIRA® Special Investigation (Long-term Treatment in Patients With 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.
Detailed Summary:
Sponsor: AbbVie
Current Primary Outcome: Incidence of adverse drug reactions (ADR) [ Time Frame: Up to Week 52 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of Overall improvement [ Time Frame: Up to Week 52 ]This is assessed by physicians.
- Change in Anterior Chamber (AC) cell grade (standardization of uveitis nomenclature (SUN) criteria) in each eye [ Time Frame: 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.
- Change in Vitreous Haze grade in each eye [ Time Frame: 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 [ Time Frame: From Week 0 (baseline) to Week 52 ]The change in retinal lesion are assessed.
- Change in Visual acuity in each eye [ Time Frame: From Week 0 (baseline) to Week 52 ]Visual acuity change is assessed.
- Change in Visual Functioning Questionnaire (VFQ)-25 score [ Time Frame: 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 [ Time Frame: From Week 0 (baseline) to Week 52 ]This is assessed by Optical Coherence Tomography (OCT)
Original Secondary Outcome: Same as current
Information By: AbbVie
Dates:
Date Received: September 14, 2016
Date Started: November 18, 2016
Date Completion: May 31, 2020
Last Updated: May 11, 2017
Last Verified: May 2017