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

Completed

• Conditions: Uveitis

• Registration Number: NCT02916017
• Lead Sponsor: AbbVie

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-24
• Study First Posted: 2016-09-27
• Study Start: 2016-11-15
• Primary Completion: 2020-10-14
• Study Completion: 2020-10-14
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

Inclusion Criteria

• Participants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis

Exclusion Criteria

• Participants previously treated with adalimumab

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions (ADR)	Up to Week 52	ADR is the causal relationship between adalimumab and adverse events.

Secondary Outcome Measures

Name	Time	Method
Change in retinal lesions in each eye	From Week 0 (baseline) to Week 52	The change in retinal lesion are assessed.
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 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.
Change in Visual acuity in each eye	From Week 0 (baseline) to Week 52	Visual acuity change is assessed.
Percentage of Overall improvement	Up to Week 52	This is assessed by physicians.
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.

Trial Locations

Locations (39)

Juntendo University Urayasu Hospital /ID# 168358; 🇯🇵 Urayasu-shi, Chiba, Japan

Matsuyama Red Cross Hospital /ID# 164149; 🇯🇵 Matsuyama-shi, Ehime, Japan

Kyushu University Hospital /ID# 163042; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Fukuoka University Hospital /ID# 163043; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Kurume University Hospital /ID# 162945; 🇯🇵 Kurume-shi, Fukuoka, Japan

Gunma University Hospital /ID# 166916; 🇯🇵 Maebashi-shi, Gunma, Japan

Hiroshima University Hospital /ID# 166915; 🇯🇵 Hiroshima-shi, Hiroshima, Japan

Hokkaido University Hospital /ID# 163041; 🇯🇵 Sapporo-shi, Hokkaido, Japan

Kobe University Hospital /ID# 165250; 🇯🇵 Kobe-shi, Hyogo, Japan

Duplicate_Kanazawa University Hospital /ID# 166914; 🇯🇵 Kanazawa-shi, Ishikawa, Japan

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