[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"juvenile-idiopathic-arthritis-associated-uveitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:juvenile-idiopathic-arthritis-associated-uveitis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100053772","phase-4-adalimumab-dose-adjustment-for-pediatric-uveitis-treatment-trial-100053772",false,"NCT07699107","Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial","ADAPT","Inclusion Criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study period\n* History of juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU), diagnosed prior to 16 years of age (patient may be older than 16 at time of enrollment)\n* ≥2 years of age (per FDA approval for use in children with polyarticular JIA)\n* Weight must be ≥15kg\n* Formal diagnosis of JIA-associated uveitis or CAU with no other suspected etiology\n* ≥24 consecutive months of controlled ocular inflammation (≤0.5+ anterior chamber cell, ≤0.5+ vitreous haze, and no active retinal\u002Fchoroidal lesions in either eye)\n* ≥24 consecutive months of controlled arthritis verified by a pediatric rheumatologist if defined as JIA-associated uveitis\n* ≥24 consecutive months of treatment with adalimumab or biosimilar of adalimumab\n* ≥180 days on a stable dose of adalimumab or biosimilar of adalimumab; dose must be no greater than 20mg (if weight \\\u003C30kg), or 40mg (if weight ≥30kg), injected every two weeks\n* If on biosimilar of adalimumab, ≥90 days on the biosimilar\n* Ability to continue to obtain commercial supply of adalimumab or biosimilar\n* If on a conventional disease-modifying anti-rheumatic drug (cDMARD) (injectable or oral methotrexate, mycophenolate mofetil, azathioprine, or leflunomide), dose must be ≤25 mg weekly for methotrexate, ≤3 g daily for mycophenolate mofetil, ≤250 mg daily for azathioprine, or ≤20 mg daily for leflunomide; dose and route of administration must be stable for ≥90 days\n* Willingness to limit consumption of alcohol during the study period\n* Agreement to avoid live attenuated vaccinations\n* Agreement to use highly effective contraception or abstinence for ≥28 days prior to screening and throughout the study period (for males and females of reproductive age)\n* Suitable, in the opinion of the Investigator, to continue treatment with adalimumab\u002Fbiosimilar per regional labeling\n\nExclusion Criteria:\n\n* History of acute anterior uveitis characterized by redness and symptoms, including but not limited to floaters, pain, and light sensitivity\n* Intraocular surgery in the past 90 days or planned surgery in the next 24 weeks\n* Severe cataract or opacity preventing view to the posterior pole in both eyes\n* Chronic hypotony (\\\u003C5mmHg for ≥90 days) in either eye\n* Treatment with oral corticosteroids or intraocular corticosteroid injection within the last 24 weeks\n* Use of topical corticosteroid eye drops within the last 90 days\n* Use of nonsteroidal anti-inflammatory drug (NSAID) eye drops within the last 90 days\n* Pregnancy or lactation (a pregnancy test will be conducted at baseline and follow-up visits for females post-menarche)\n* Presence of intraretinal or subretinal fluid in either eye\n* Prior safety or tolerability issues with adalimumab\n* History of cancer, active tuberculosis, or hepatitis B\n* Other medical condition expected to dictate treatment course during the study\n* Any of the following laboratory test results on their most recent tests within the past 90 days prior to screening\u002Fenrollment: leukocyte count \\\u003C2500, platelet count ≤75000, hemoglobin\\\u003C9.0, aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 2 times the upper limit of normal range, creatinine ≥1.5","ALL","2 Years",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The goal of this clinical trial is to learn whether children and young adults with well-controlled juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior uveitis can safely take adalimumab (or biosimilar) injections less often while maintaining control of their disease.\n\nThe main question it aims to answer is: can adalimumab\u002Fbiosimilar injections be given less frequently without uveitis (eye inflammation) or arthritis (joint inflammation) returning?\n\nResearchers will compare adalimumab\u002Fbiosimilar injection schedules of every 2 weeks, 4 weeks, 8 weeks, and 12 weeks to determine how injection frequency affects disease control.\n\nParticipants will:\n\n* Take adalimumab\u002Fbiosimilar injections every 2, 4, 8, or 12 weeks.\n* Attend study visits every 6 weeks over 24 weeks, with an additional follow-up visit at 48 weeks for checkups, tests, and questionnaires.\n* Keep a diary of how often they take adalimumab\u002Fbiosimilar and other drugs they take for their uveitis\u002Farthritis.",[26,27],"Juvenile Idiopathic Arthritis Associated Uveitis","Uveitis, Anterior",[29,30,31,32],"Adalimumab","JIA-associated uveitis","Chronic anterior uveitis","reduced frequency dosing","NOT_YET_RECRUITING","2026-07-07",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":20},"2026-09",{"date":41,"type":20},"2030-11",{"name":43,"class":44},"Nisha Acharya","OTHER",18]