HUMIRA® Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 259
- Participants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis
- 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)
Nippon Medical School Hospital /ID# 166938
🇯🇵Bunkyo-ku, Tokyo, Japan
The University of Tokyo Hospital /ID# 162943
🇯🇵Bunkyo-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
Kagoshima Uni Med and Dental /ID# 164150
🇯🇵Kagoshima, Japan
Duplicate_The Hospital of Hyogo College /ID# 166913
🇯🇵Nishinomiya-shi, Japan
Osaka Hospital /ID# 164151
🇯🇵Osaka, Japan
Center Hospital of the National Center for Global Health and Medicine /ID# 164148
🇯🇵Shinjuku-ku, Tokyo, Japan
The Jikei University Hospital /ID# 164152
🇯🇵Minato-ku, Tokyo, Japan
Yamaguchi University Hospital /ID# 165249
🇯🇵Ube-shi, Yamaguchi, Japan
Tokyo Medical And Dental University, Medical Hospital /ID# 165251
🇯🇵Bunkyo-ku, Tokyo, Japan
Kakogawa Central City Hospital /ID# 167706
🇯🇵Kakogawa, Japan
Juntendo University Hospital /ID# 169564
🇯🇵Bunkyo-ku, Tokyo, Japan
Yodogawa Christian Hospital /ID# 161741
🇯🇵Osaka-shi, Japan
Tottori Municipal Hospital /ID# 159431
🇯🇵Tottori, Japan
Miyata Ophthalmic Hospital /ID# 167707
🇯🇵Miyakonojo, Japan
Omihachiman Community Med Ctr /ID# 164978
🇯🇵Omihachiman, Japan
Abbott Japan /ID# 147893
🇯🇵Tokyo, Japan
Tokyo Shinjuku Medical Center /ID# 166934
🇯🇵Tokyo, Japan
Tosei General Hospital /ID# 167708
🇯🇵Seto, Japan
Natl Defense Med College Hosp /ID# 162946
🇯🇵Tokorozawa, Japan
Juntendo University Urayasu Hospital /ID# 168358
🇯🇵Urayasu-shi, Chiba, Japan
Matsuyama Red Cross Hospital /ID# 164149
🇯🇵Matsuyama-shi, Ehime, Japan
Kurume University Hospital /ID# 162945
🇯🇵Kurume-shi, Fukuoka, Japan
Gunma University Hospital /ID# 166916
🇯🇵Maebashi-shi, Gunma, Japan
Fukuoka University Hospital /ID# 163043
🇯🇵Fukuoka-shi, Fukuoka, Japan
Hokkaido University Hospital /ID# 163041
🇯🇵Sapporo-shi, Hokkaido, Japan
Kobe University Hospital /ID# 165250
🇯🇵Kobe-shi, Hyogo, Japan
Kochi Medical School Hospital /ID# 164144
🇯🇵Nankoku-shi, Kochi, Japan
Kyushu University Hospital /ID# 163042
🇯🇵Fukuoka-shi, Fukuoka, Japan
Hiroshima University Hospital /ID# 166915
🇯🇵Hiroshima-shi, Hiroshima, Japan
Shinshu University Hospital /ID# 164153
🇯🇵Matsumoto-shi, Nagano, Japan
Duplicate_Kanazawa University Hospital /ID# 166914
🇯🇵Kanazawa-shi, Ishikawa, Japan
Yokohama Municipal Citizen's Hospital /ID# 161742
🇯🇵Yokohama, Kanagawa, Japan
Niigata University Medical & Dental Hospital /ID# 169563
🇯🇵Niigata-shi, Niigata, Japan
Saitama Medical University Hospital /ID# 162944
🇯🇵Iruma-gun, Saitama, Japan
Dokkyo Medical University Hospital /ID# 164154
🇯🇵Shimotsuga-gun, Tochigi, Japan
Osaka University Hospital /ID# 164147
🇯🇵Suita-shi, Osaka, Japan
Tokushima University Hospital /ID# 164145
🇯🇵Tokushima-shi, Tokushima, Japan