[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053772":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":45,"centralContacts":49,"locations":55,"responsibleParty":355,"collaborators":359,"id":398,"slug":53,"hasResults":399,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":399,"sex":404,"minAge":405,"maxAge":53,"enrollmentInfo":406,"targetDuration":53,"studyType":409,"phases":410,"briefSummary":412,"conditions":413,"keywords":416,"overallStatus":421,"whyStopped":53,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"2-Week Dose","ACTIVE_COMPARATOR","Participants receive adalimumab\u002Fbiosimilar at their current weight-based dose every 2 weeks for 24 weeks, continuing in accordance with current standard of care practice.",[13],"Biological: Adalimumab\u002FBiosimilar",{"label":15,"type":16,"description":17,"interventionNames":18},"4-Week Dose","EXPERIMENTAL","Participants receive adalimumab\u002Fbiosimilar at their current weight-based dose every 4 weeks for 24 weeks.",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"8-Week Dose","Participants receive adalimumab\u002Fbiosimilar at their current weight-based dose every 8 weeks for 24 weeks.",[13],{"label":24,"type":16,"description":25,"interventionNames":26},"12-Week Dose","Participants receive adalimumab\u002Fbiosimilar at their current weight-based dose every 12 weeks for 24 weeks.",[13],[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BIOLOGICAL","Adalimumab\u002FBiosimilar","Adalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody - a biologic, immunomodulatory drug. Adalimumab (20mg or 40mg) is a clear, colorless solution available as an injectable auto-pen or pre-filled syringe for subcutaneous injection. All FDA-approved adalimumab biosimilars are allowed for this trial and include: Abrilada (adalimumab-afzb), Amjevita (adalimumab-atto), Cyltezo (adalimumab-adbm), Hadlima (adalimumab-bwwd), Hulio (adalimumab-fkjp), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Simlandi (adalimumab-ryvk), Yuflyma (adalimumab-aaty), and Yusimry (adalimumab-aqvh).",[24,9,15,20],[34,35,36,37,38,39,40,41,42,43,44],"Humira","Abrilada","Amjevita","Cyltezo","Hadlima","Hulio","Hyrimoz","Idacio","Simlandi","Yuflyma","Yusimry",[46],{"name":47,"affiliation":5,"role":48},"Nisha Acharya, MD MS","PRINCIPAL_INVESTIGATOR",[50],{"name":47,"role":51,"phone":52,"phoneExt":53,"email":54},"CONTACT","415-476-8131",null,"Nisha.Acharya@ucsf.edu",[56,74,92,109,126,144,162,180,196,212,230,248,264,281,299,314,329,346],{"facility":57,"status":53,"city":58,"state":59,"zip":60,"country":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"University of California, Los Angeles","Los Angeles","California","90095","United States",{"type":63,"coordinates":64},"Point",[65,66],-118.24368,34.05223,{"lat":66,"lon":65},[69,73],{"name":70,"role":51,"phone":71,"phoneExt":53,"email":72},"Edmund Tsui, MD","310-825-5440","etsui@mednet.ucla.edu",{"name":70,"role":48,"phone":53,"phoneExt":53,"email":53},{"facility":75,"status":53,"city":76,"state":59,"zip":77,"country":61,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"University of California, Davis","Sacramento","95817",{"type":63,"coordinates":79},[80,81],-121.4944,38.58157,{"lat":81,"lon":80},[84,88,90],{"name":85,"role":51,"phone":86,"phoneExt":53,"email":87},"Parisa Emami-Naeini, MD, MPH","916-734-6602","parisaemami@gmail.com",{"name":89,"role":48,"phone":53,"phoneExt":53,"email":53},"Parisa Emami-Naeini, MD MPH",{"name":91,"role":48,"phone":53,"phoneExt":53,"email":53},"Angel Herrera-Guerra, MD PhD",{"facility":5,"status":53,"city":93,"state":59,"zip":94,"country":61,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"San Francisco","94143",{"type":63,"coordinates":96},[97,98],-122.41942,37.77493,{"lat":98,"lon":97},[101,102,104,107],{"name":47,"role":51,"phone":52,"phoneExt":53,"email":54},{"name":103,"role":48,"phone":53,"phoneExt":53,"email":53},"Nisha Acharya, MD",{"name":105,"role":106,"phone":53,"phoneExt":53,"email":53},"Thuy Doan, MD PhD","SUB_INVESTIGATOR",{"name":108,"role":106,"phone":53,"phoneExt":53,"email":53},"John Gonzales, MD",{"facility":110,"status":53,"city":111,"state":112,"zip":113,"country":61,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"University of Miami","Miami","Florida","33136",{"type":63,"coordinates":115},[116,117],-80.19366,25.77427,{"lat":117,"lon":116},[120,123,124],{"name":121,"role":51,"phone":53,"phoneExt":53,"email":122},"Stephanie Llop, MD","sxl1789@med.miami.edu",{"name":121,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":125,"role":106,"phone":53,"phoneExt":53,"email":53},"Janet Davis, MD",{"facility":127,"status":53,"city":128,"state":129,"zip":130,"country":61,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Children's Mercy Hospital","Kansas City","Missouri","64108",{"type":63,"coordinates":132},[133,134],-94.57857,39.09973,{"lat":134,"lon":133},[137,141,142],{"name":138,"role":51,"phone":139,"phoneExt":53,"email":140},"Erin Stahl, MD","816-960-8000","edstahl@cmh.edu",{"name":138,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":143,"role":48,"phone":53,"phoneExt":53,"email":53},"Ashley Cooper, MD",{"facility":145,"status":53,"city":146,"state":147,"zip":148,"country":61,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Cincinnati Children's Hospital","Cincinnati","Ohio","45229",{"type":63,"coordinates":150},[151,152],-84.51439,39.12711,{"lat":152,"lon":151},[155,159,160],{"name":156,"role":51,"phone":157,"phoneExt":53,"email":158},"Sheila Angeles-Han, MD","513-517-2057","Sheila.Angeles-Han@cchmc.org",{"name":156,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":161,"role":48,"phone":53,"phoneExt":53,"email":53},"Virginia Miraldi Utz, MD",{"facility":163,"status":53,"city":164,"state":165,"zip":166,"country":61,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Vanderbilt University Medical Center","Nashville","Tennessee","37212",{"type":63,"coordinates":168},[169,170],-86.78444,36.16589,{"lat":170,"lon":169},[173,177,178],{"name":174,"role":51,"phone":175,"phoneExt":53,"email":176},"Sapna Gangaputra, MD MPH","615-936-3921","sapna.gangaputra@vumc.org",{"name":174,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":179,"role":48,"phone":53,"phoneExt":53,"email":53},"Thomas (Brent) Graham, MD MS",{"facility":181,"status":53,"city":182,"state":183,"zip":184,"country":61,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"University of Texas, Austin","Austin","Texas","78712",{"type":63,"coordinates":186},[187,188],-97.74306,30.26715,{"lat":188,"lon":187},[191,195],{"name":192,"role":51,"phone":193,"phoneExt":53,"email":194},"Eric Crowell, MD MPH","512-495-5899","eric.crowell@austin.utexas.edu",{"name":192,"role":48,"phone":53,"phoneExt":53,"email":53},{"facility":197,"status":53,"city":198,"state":199,"zip":200,"country":61,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"University of Utah Health","Salt Lake City","Utah","84132",{"type":63,"coordinates":202},[203,204],-111.89105,40.76078,{"lat":204,"lon":203},[207,211],{"name":208,"role":51,"phone":209,"phoneExt":53,"email":210},"Marissa Larochelle, MD","801-581-2352","marissa.larochelle@hsc.utah.edu",{"name":208,"role":48,"phone":53,"phoneExt":53,"email":53},{"facility":213,"status":53,"city":214,"state":53,"zip":215,"country":216,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Meyer Children's Hospital","Florence","50139","Italy",{"type":63,"coordinates":218},[219,220],11.24626,43.77925,{"lat":220,"lon":219},[223,227,228],{"name":224,"role":51,"phone":225,"phoneExt":53,"email":226},"Gabriele Simonini","(+39) 05 55662924","gabriele.simonini@unifi.it",{"name":224,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":229,"role":48,"phone":53,"phoneExt":53,"email":53},"Ilaria Maccora",{"facility":231,"status":53,"city":232,"state":53,"zip":233,"country":234,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"University Hospitals Bristol and Weston","Bristol","BS1 3NU","United Kingdom",{"type":63,"coordinates":236},[237,238],-2.59665,51.45523,{"lat":238,"lon":237},[241,245,246],{"name":242,"role":51,"phone":243,"phoneExt":53,"email":244},"A V Ramanan","+44 117 3420149","avramanan@hotmail.com",{"name":242,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":247,"role":48,"phone":53,"phoneExt":53,"email":53},"Catherine Guly",{"facility":249,"status":53,"city":250,"state":53,"zip":251,"country":234,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"University Hospitals of Leicester","Leicester","LE1 5WW",{"type":63,"coordinates":253},[254,255],-1.13169,52.6386,{"lat":255,"lon":254},[258,261,262],{"name":259,"role":51,"phone":53,"phoneExt":53,"email":260},"Arani Sridhar","arani.sridhar@uhl-tr.nhs.uk",{"name":259,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":263,"role":48,"phone":53,"phoneExt":53,"email":53},"Bharat Kapoor",{"facility":265,"status":53,"city":266,"state":53,"zip":267,"country":234,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"Alder Hey Children's Hospital","Liverpool","L14 5AB",{"type":63,"coordinates":269},[270,271],-2.97794,53.41058,{"lat":271,"lon":270},[274,278,279],{"name":275,"role":51,"phone":276,"phoneExt":53,"email":277},"Jose Gonzalez-Martin","+44 151 752 5839","Jose.Gonzalez-Martin@alderhey.nhs.uk",{"name":275,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":280,"role":48,"phone":53,"phoneExt":53,"email":53},"Gavin Cleary",{"facility":282,"status":53,"city":283,"state":53,"zip":284,"country":234,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"Great Ormond Street Hospital","London","WC1N 3JH",{"type":63,"coordinates":286},[287,288],-0.12574,51.50853,{"lat":288,"lon":287},[291,294,295,297],{"name":292,"role":51,"phone":53,"phoneExt":53,"email":293},"Elena Moraitis","elena.moraitis@gosh.nhs.uk",{"name":292,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":296,"role":48,"phone":53,"phoneExt":53,"email":53},"Harry Petrushkin",{"name":298,"role":106,"phone":53,"phoneExt":53,"email":53},"Lola Solebo",{"facility":300,"status":53,"city":301,"state":53,"zip":302,"country":234,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"Manchester University NHS Foundation Trust","Manchester","M13 9WL",{"type":63,"coordinates":304},[305,306],-2.23743,53.48095,{"lat":306,"lon":305},[309,313],{"name":310,"role":51,"phone":311,"phoneExt":53,"email":312},"Jane Ashworth","+44 794 461 6005","jane.ashworth@mft.nhs.uk",{"name":310,"role":48,"phone":53,"phoneExt":53,"email":53},{"facility":315,"status":53,"city":316,"state":53,"zip":317,"country":234,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"Great North Children's Hospital","Newcastle upon Tyne","NE1 4LP",{"type":63,"coordinates":319},[320,321],-1.61396,54.97328,{"lat":321,"lon":320},[324,328],{"name":325,"role":51,"phone":326,"phoneExt":53,"email":327},"Sharmila Jandial","+44 191 282 5318","Sharmila.Jandial@nhs.net",{"name":325,"role":48,"phone":53,"phoneExt":53,"email":53},{"facility":330,"status":53,"city":331,"state":53,"zip":332,"country":234,"cosmosGeoPoint":333,"geoPoint":337,"contacts":338},"Norfolk and Norwich University Hospital","Norwich","NR4 6TZ",{"type":63,"coordinates":334},[335,336],1.29834,52.62783,{"lat":336,"lon":335},[339,343,344],{"name":340,"role":51,"phone":341,"phoneExt":53,"email":342},"Narman Puvanachandra","+44 1603288374","narman.puvanachandra@nnuh.nhs.uk",{"name":340,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":345,"role":48,"phone":53,"phoneExt":53,"email":53},"Kate Armon",{"facility":347,"status":53,"city":348,"state":53,"zip":349,"country":234,"cosmosGeoPoint":350,"geoPoint":354,"contacts":53},"Sheffield Children's Hospital","Sheffield","S10 2TQ",{"type":63,"coordinates":351},[352,353],-1.4659,53.38297,{"lat":353,"lon":352},{"type":356,"investigatorFullName":357,"investigatorTitle":358,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"SPONSOR_INVESTIGATOR","Nisha Acharya","Principal Investigator",[360,363,365,366,367,368,370,372,373,375,377,378,380,382,384,386,388,390,392,394,396],{"name":361,"class":362},"National Eye Institute (NEI)","NIH",{"name":364,"class":362},"National Institutes of Health (NIH)",{"name":5,"class":6},{"name":75,"class":6},{"name":57,"class":6},{"name":369,"class":6},"Children's Hospital Medical Center, Cincinnati",{"name":371,"class":6},"Children's Mercy Hospital Kansas City",{"name":110,"class":6},{"name":374,"class":6},"University of Utah",{"name":376,"class":6},"University of Texas at Austin",{"name":163,"class":6},{"name":379,"class":6},"University Hospitals Bristol and Weston NHS Foundation Trust",{"name":381,"class":6},"Alder Hey Children's NHS Foundation Trust",{"name":383,"class":6},"Great Ormond Street Hospital for Children NHS Foundation Trust",{"name":385,"class":6},"Norfolk and Norwich University Hospitals NHS Foundation Trust",{"name":300,"class":387},"OTHER_GOV",{"name":389,"class":6},"Sheffield Children's NHS Foundation Trust",{"name":391,"class":6},"University Hospitals, Leicester",{"name":393,"class":6},"Meyer Children's Hospital IRCCS",{"name":395,"class":6},"Newcastle-upon-Tyne Hospitals NHS Trust",{"name":397,"class":6},"Moorfields Eye Hospital NHS Foundation Trust","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":407,"type":408},160,"ESTIMATED","INTERVENTIONAL",[411],"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.",[414,415],"Juvenile Idiopathic Arthritis Associated Uveitis","Uveitis, Anterior",[417,418,419,420],"Adalimumab","JIA-associated uveitis","Chronic anterior uveitis","reduced frequency dosing","NOT_YET_RECRUITING","2026-07-07",{"date":424,"type":425},"2026-07-13","ACTUAL",{"date":427,"type":408},"2026-09",{"date":429,"type":408},"2030-11",{"name":357,"class":6},18]