Efficacy and safety of adalimumab for inflammatory flare prevention in paediatric non-infectious anterior uveitis with peripheral retinal vascular leakage: a study protocol for a single-centre, randomised controlled trial
Introduction Paediatric patients with chronic anterior uveitis are more prone to suffer from the chronic course of intraocular inflammation and adverse effects of long-term immunomodulatory therapy, either topical glucocorticosteroids or systemic immunomodulatory agents. The performance of adalimuma...
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BMJ Publishing Group
2022-12-01
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| author | Fei Gao Yuelun Zhang Donghui Li Chan Zhao Meifen Zhang Hang Song Yujing Qian Junyan Xiao |
| author_facet | Fei Gao Yuelun Zhang Donghui Li Chan Zhao Meifen Zhang Hang Song Yujing Qian Junyan Xiao |
| author_sort | Fei Gao |
| collection | DOAJ |
| description | Introduction Paediatric patients with chronic anterior uveitis are more prone to suffer from the chronic course of intraocular inflammation and adverse effects of long-term immunomodulatory therapy, either topical glucocorticosteroids or systemic immunomodulatory agents. The performance of adalimumab has been shown to be fairly favourable in treating refractory non-infectious uveitis, but the detailed indication is still under investigation. This study aims to assess the efficacy and safety of adalimumab for inflammatory flare prevention in non-infectious paediatric anterior uveitis with peripheral retinal vascular leakage, compared with methotrexate.Methods and analysis Children weighed ≥30 kg and aged between 4 and 16 years old with active non-infectious anterior uveitis with peripheral retinal vascular leakage on ultra-wildfield fluorescein fundus angiography will be included. They will be treated with a predesigned inflammatory control regimen to reach inflammatory quiescence in 1 month. After that they will be treated with either methotrexate 10 mg once a week or adalimumab once every 2 weeks and regularly followed up for 6 months. The primary endpoint is uveitis flare defined as defined as anterior chamber cell count grading increased from 0 to 1 within the observation period.Ethics and dissemination The study was approved by the Institutional Review Board of Peking Union Medical College Hospital, Beijing, China (Approved protocol V3, dated 27 July 2021. Approval number 25-ZS-3062) and has been registered on ClinicalTrials.gov. Written informed consent will be collected from every patient and their guardians prior to study participation. The results of this trial will be presented at local and international meetings and submitted to peer-reviewed journals for publication.Trial registration number NCT05015335. |
| format | Article |
| id | doaj-art-ce817249fa9e43c1b95ee8038230a735 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-ce817249fa9e43c1b95ee8038230a7352025-08-20T02:14:31ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-062211Efficacy and safety of adalimumab for inflammatory flare prevention in paediatric non-infectious anterior uveitis with peripheral retinal vascular leakage: a study protocol for a single-centre, randomised controlled trialFei Gao0Yuelun Zhang1Donghui Li2Chan Zhao3Meifen Zhang4Hang Song5Yujing Qian6Junyan Xiao73 National Heart Research Institute Singapore, National Heart Centre Singapore, Singapore3 Medical Research Center, Peking Union Medical College Hospital, Beijing, China1Tessera Therapeutics, Somerville, MA, USA2 Department of Ophthalmology, Peking Union Medical College Hospital, Key Laboratory of Ocular Fundus Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China1 School of Nursing, Sun Yat-sen University, Guangzhou, ChinaDepartment of Ophthalmology, Key laboratory of Ocular Fundus Diseases, Peking Union Medical College Hospital, Beijing, ChinaDepartment of Ophthalmology, Key laboratory of Ocular Fundus Diseases, Peking Union Medical College Hospital, Beijing, ChinaDepartment of Ophthalmology, Fudan University Eye Ear Nose and Throat Hospital Department of Ophthalmology, Shanghai, ChinaIntroduction Paediatric patients with chronic anterior uveitis are more prone to suffer from the chronic course of intraocular inflammation and adverse effects of long-term immunomodulatory therapy, either topical glucocorticosteroids or systemic immunomodulatory agents. The performance of adalimumab has been shown to be fairly favourable in treating refractory non-infectious uveitis, but the detailed indication is still under investigation. This study aims to assess the efficacy and safety of adalimumab for inflammatory flare prevention in non-infectious paediatric anterior uveitis with peripheral retinal vascular leakage, compared with methotrexate.Methods and analysis Children weighed ≥30 kg and aged between 4 and 16 years old with active non-infectious anterior uveitis with peripheral retinal vascular leakage on ultra-wildfield fluorescein fundus angiography will be included. They will be treated with a predesigned inflammatory control regimen to reach inflammatory quiescence in 1 month. After that they will be treated with either methotrexate 10 mg once a week or adalimumab once every 2 weeks and regularly followed up for 6 months. The primary endpoint is uveitis flare defined as defined as anterior chamber cell count grading increased from 0 to 1 within the observation period.Ethics and dissemination The study was approved by the Institutional Review Board of Peking Union Medical College Hospital, Beijing, China (Approved protocol V3, dated 27 July 2021. Approval number 25-ZS-3062) and has been registered on ClinicalTrials.gov. Written informed consent will be collected from every patient and their guardians prior to study participation. The results of this trial will be presented at local and international meetings and submitted to peer-reviewed journals for publication.Trial registration number NCT05015335.https://bmjopen.bmj.com/content/12/12/e062211.full |
| spellingShingle | Fei Gao Yuelun Zhang Donghui Li Chan Zhao Meifen Zhang Hang Song Yujing Qian Junyan Xiao Efficacy and safety of adalimumab for inflammatory flare prevention in paediatric non-infectious anterior uveitis with peripheral retinal vascular leakage: a study protocol for a single-centre, randomised controlled trial BMJ Open |
| title | Efficacy and safety of adalimumab for inflammatory flare prevention in paediatric non-infectious anterior uveitis with peripheral retinal vascular leakage: a study protocol for a single-centre, randomised controlled trial |
| title_full | Efficacy and safety of adalimumab for inflammatory flare prevention in paediatric non-infectious anterior uveitis with peripheral retinal vascular leakage: a study protocol for a single-centre, randomised controlled trial |
| title_fullStr | Efficacy and safety of adalimumab for inflammatory flare prevention in paediatric non-infectious anterior uveitis with peripheral retinal vascular leakage: a study protocol for a single-centre, randomised controlled trial |
| title_full_unstemmed | Efficacy and safety of adalimumab for inflammatory flare prevention in paediatric non-infectious anterior uveitis with peripheral retinal vascular leakage: a study protocol for a single-centre, randomised controlled trial |
| title_short | Efficacy and safety of adalimumab for inflammatory flare prevention in paediatric non-infectious anterior uveitis with peripheral retinal vascular leakage: a study protocol for a single-centre, randomised controlled trial |
| title_sort | efficacy and safety of adalimumab for inflammatory flare prevention in paediatric non infectious anterior uveitis with peripheral retinal vascular leakage a study protocol for a single centre randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/12/e062211.full |
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