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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02916017
Other study ID # P15-665
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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