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

Uveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916017
• Other study ID #: P15-665
• Status: Completed
• Start date: November 15, 2016
• Est. completion date: October 14, 2020

Study information

• Verified date: October 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: October 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Participants previously treated with adalimumab

Related Conditions & MeSH terms

• Panuveitis
• Uveitis

Locations

Country	Name	City	State
Japan	Juntendo University Hospital /ID# 169564	Bunkyo-ku	Tokyo
Japan	Nippon Medical School Hospital /ID# 166938	Bunkyo-ku	Tokyo
Japan	The University of Tokyo Hospital /ID# 162943	Bunkyo-ku	Tokyo
Japan	Tokyo Medical And Dental University, Medical Hospital /ID# 165251	Bunkyo-ku	Tokyo
Japan	Fukuoka University Hospital /ID# 163043	Fukuoka-shi	Fukuoka
Japan	Kyushu University Hospital /ID# 163042	Fukuoka-shi	Fukuoka
Japan	Hiroshima University Hospital /ID# 166915	Hiroshima-shi	Hiroshima
Japan	Saitama Medical University Hospital /ID# 162944	Iruma-gun	Saitama
Japan	Kagoshima Uni Med and Dental /ID# 164150	Kagoshima
Japan	Kakogawa Central City Hospital /ID# 167706	Kakogawa
Japan	Duplicate_Kanazawa University Hospital /ID# 166914	Kanazawa-shi	Ishikawa
Japan	Kobe University Hospital /ID# 165250	Kobe-shi	Hyogo
Japan	Kurume University Hospital /ID# 162945	Kurume-shi	Fukuoka
Japan	Gunma University Hospital /ID# 166916	Maebashi-shi	Gunma
Japan	Shinshu University Hospital /ID# 164153	Matsumoto-shi	Nagano
Japan	Matsuyama Red Cross Hospital /ID# 164149	Matsuyama-shi	Ehime
Japan	The Jikei University Hospital /ID# 164152	Minato-ku	Tokyo
Japan	Miyata Ophthalmic Hospital /ID# 167707	Miyakonojo
Japan	Kochi Medical School Hospital /ID# 164144	Nankoku-shi	Kochi
Japan	Niigata University Medical & Dental Hospital /ID# 169563	Niigata-shi	Niigata
Japan	Duplicate_The Hospital of Hyogo College /ID# 166913	Nishinomiya-shi
Japan	Omihachiman Community Med Ctr /ID# 164978	Omihachiman
Japan	Osaka Hospital /ID# 164151	Osaka
Japan	Yodogawa Christian Hospital /ID# 161741	Osaka-shi
Japan	Hokkaido University Hospital /ID# 163041	Sapporo-shi	Hokkaido
Japan	Tosei General Hospital /ID# 167708	Seto
Japan	Dokkyo Medical University Hospital /ID# 164154	Shimotsuga-gun	Tochigi
Japan	Center Hospital of the National Center for Global Health and Medicine /ID# 164148	Shinjuku-ku	Tokyo
Japan	Tokyo Medical University Hospital /ID# 164146	Shinjuku-ku	Tokyo
Japan	Tokyo Women's Medical University Hospital /ID# 165248	Shinjuku-ku	Tokyo
Japan	Osaka University Hospital /ID# 164147	Suita-shi	Osaka
Japan	Natl Defense Med College Hosp /ID# 162946	Tokorozawa
Japan	Tokushima University Hospital /ID# 164145	Tokushima-shi	Tokushima
Japan	Abbott Japan /ID# 147893	Tokyo
Japan	Tokyo Shinjuku Medical Center /ID# 166934	Tokyo
Japan	Tottori Municipal Hospital /ID# 159431	Tottori
Japan	Yamaguchi University Hospital /ID# 165249	Ube-shi	Yamaguchi
Japan	Juntendo University Urayasu Hospital /ID# 168358	Urayasu-shi	Chiba
Japan	Yokohama Municipal Citizen's Hospital /ID# 161742	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions (ADR)	ADR is the causal relationship between adalimumab and adverse events.	Up to Week 52
Secondary	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
Secondary	Change in Visual acuity in each eye	Visual acuity change is assessed.	From Week 0 (baseline) to Week 52
Secondary	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
Secondary	Percentage of Overall improvement	This is assessed by physicians.	Up to Week 52
Secondary	Change in retinal lesions in each eye	The change in retinal lesion are assessed.	From Week 0 (baseline) to Week 52
Secondary	Change in central retinal thickness in each eye	This is assessed by Optical Coherence Tomography (OCT)	From Week 0 (baseline) to Week 52
Secondary	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

External Links

•   clinical study report synopsis