Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving adalimumab | Participants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions (ADR) | ADR is the causal relationship between adalimumab and adverse events. | Up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Participants with Non-infectious Intermediate-, Posterior-, or Pan-uveitis
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juntendo University Urayasu Hospital /ID# 168358 | Urayasu-shi | Chiba | 279-0021 | Japan | ||
| Matsuyama Red Cross Hospital /ID# 164149 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35305254 | Derived | Namba K, Kaburaki T, Tsuruga H, Ogawa Y, Iwashita E, Goto H. Long-Term Safety and Effectiveness of Adalimumab in Japanese Patients with Noninfectious Intermediate, Posterior, or Panuveitis: Post-Marketing Surveillance of 251 Patients. Ophthalmol Ther. 2022 Jun;11(3):1147-1161. doi: 10.1007/s40123-022-00493-z. Epub 2022 Mar 19. |
| Label | URL |
|---|---|
| clinical study report synopsis | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From Week 0 (baseline) to Week 52 |
| Change in Visual acuity in each eye | Visual acuity change is assessed. | From Week 0 (baseline) to Week 52 |
| 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 |
| Percentage of Overall improvement | This is assessed by physicians. | Up to Week 52 |
| Change in retinal lesions in each eye | The change in retinal lesion are assessed. | From Week 0 (baseline) to Week 52 |
| Change in central retinal thickness in each eye | This is assessed by Optical Coherence Tomography (OCT) | From Week 0 (baseline) to Week 52 |
| 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 |
| Matsuyama |
| Ehime |
| 790-0826 |
| Japan |
| Kyushu University Hospital /ID# 163042 | Fukuoka | Fukuoka | 812-8582 | Japan |
| Fukuoka University Hospital /ID# 163043 | Fukuoka | Fukuoka | 814-0180 | Japan |
| Kurume University Hospital /ID# 162945 | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Gunma University Hospital /ID# 166916 | Maebashi | Gunma | 371-8511 | Japan |
| Hiroshima University Hospital /ID# 166915 | Hiroshima | Hiroshima | 734-8551 | Japan |
| Hokkaido University Hospital /ID# 163041 | Sapporo | Hokkaido | 060-8648 | Japan |
| Kobe University Hospital /ID# 165250 | Kobe | Hyōgo | 650-0017 | Japan |
| Duplicate_Kanazawa University Hospital /ID# 166914 | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Yokohama Municipal Citizen's Hospital /ID# 161742 | Yokohama | Kanagawa | 240-8555 | Japan |
| Kochi Medical School Hospital /ID# 164144 | Nankoku-shi | Kochi | 783-8505 | Japan |
| Shinshu University Hospital /ID# 164153 | Matsumoto-shi | Nagano | 390-8621 | Japan |
| Niigata University Medical & Dental Hospital /ID# 169563 | Niigata | Niigata | 951-8520 | Japan |
| Osaka University Hospital /ID# 164147 | Suita-shi | Osaka | 565-0871 | Japan |
| Saitama Medical University Hospital /ID# 162944 | Iruma-gun | Saitama | 350-0451 | Japan |
| Dokkyo Medical University Hospital /ID# 164154 | Shimotsuga-gun | Tochigi | 321-0293 | Japan |
| Tokushima University Hospital /ID# 164145 | Tokushima | Tokushima | 770-8503 | Japan |
| Juntendo University Hospital /ID# 169564 | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Tokyo Medical And Dental University, Medical Hospital /ID# 165251 | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| Nippon Medical School Hospital /ID# 166938 | Bunkyo-ku | Tokyo | 113-8603 | Japan |
| The University of Tokyo Hospital /ID# 162943 | Bunkyo-ku | Tokyo | 113-8655 | Japan |
| The Jikei University Hospital /ID# 164152 | Minato-ku | Tokyo | 105-8471 | Japan |
| Tokyo Medical University Hospital /ID# 164146 | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Center Hospital of the National Center for Global Health and Medicine /ID# 164148 | Shinjuku-ku | Tokyo | 162-8655 | Japan |
| Tokyo Women's Medical University Hospital /ID# 165248 | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Yamaguchi University Hospital /ID# 165249 | Ube-shi | Yamaguchi | 755-8505 | Japan |
| Kagoshima Uni Med and Dental /ID# 164150 | Kagoshima | 890-8520 | Japan |
| Kakogawa Central City Hospital /ID# 167706 | Kakogawa | 489-0065 | Japan |
| Miyata Ophthalmic Hospital /ID# 167707 | Miyakonojō | 885-0051 | Japan |
| Duplicate_The Hospital of Hyogo College /ID# 166913 | Nishinomiya-shi | 663-8501 | Japan |
| Osaka Hospital /ID# 164151 | Osaka | 572-0854 | Japan |
| Yodogawa Christian Hospital /ID# 161741 | Osaka | Japan |
| Omihachiman Community Med Ctr /ID# 164978 | Ōmihachiman | 523-0082 | Japan |
| Tosei General Hospital /ID# 167708 | Seto | 489-8642 | Japan |
| Natl Defense Med College Hosp /ID# 162946 | Tokorozawa | 359-0042 | Japan |
| Abbott Japan /ID# 147893 | Tokyo | 108-6303 | Japan |
| Tokyo Shinjuku Medical Center /ID# 166934 | Tokyo | 162-8543 | Japan |
| Tottori Municipal Hospital /ID# 159431 | Tottori | 680-8501 | Japan |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided