[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053772":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":45,"centralContacts":49,"locations":55,"responsibleParty":358,"collaborators":362,"id":401,"slug":402,"hasResults":403,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":403,"sex":408,"minAge":409,"maxAge":53,"enrollmentInfo":410,"targetDuration":53,"studyType":413,"phases":414,"briefSummary":416,"conditions":417,"keywords":420,"overallStatus":425,"whyStopped":53,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":435},{"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",[56,75,93,110,127,145,163,181,197,213,232,251,267,284,302,317,332,349],{"facility":57,"status":53,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"University of California, Los Angeles","Los Angeles","California","90095","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-118.24368,34.05223,{"lat":67,"lon":66},[70,74],{"name":71,"role":51,"phone":72,"phoneExt":53,"email":73},"Edmund Tsui, MD","310-825-5440","etsui@mednet.ucla.edu",{"name":71,"role":48,"phone":53,"phoneExt":53,"email":53},{"facility":76,"status":53,"city":77,"state":59,"zip":78,"country":61,"countryCode":62,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"University of California, Davis","Sacramento","95817",{"type":64,"coordinates":80},[81,82],-121.4944,38.58157,{"lat":82,"lon":81},[85,89,91],{"name":86,"role":51,"phone":87,"phoneExt":53,"email":88},"Parisa Emami-Naeini, MD, MPH","916-734-6602","parisaemami@gmail.com",{"name":90,"role":48,"phone":53,"phoneExt":53,"email":53},"Parisa Emami-Naeini, MD MPH",{"name":92,"role":48,"phone":53,"phoneExt":53,"email":53},"Angel Herrera-Guerra, MD 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Hospital","Cincinnati","Ohio","45229",{"type":64,"coordinates":151},[152,153],-84.51439,39.12711,{"lat":153,"lon":152},[156,160,161],{"name":157,"role":51,"phone":158,"phoneExt":53,"email":159},"Sheila Angeles-Han, MD","513-517-2057","Sheila.Angeles-Han@cchmc.org",{"name":157,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":162,"role":48,"phone":53,"phoneExt":53,"email":53},"Virginia Miraldi Utz, MD",{"facility":164,"status":53,"city":165,"state":166,"zip":167,"country":61,"countryCode":62,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Vanderbilt University Medical Center","Nashville","Tennessee","37212",{"type":64,"coordinates":169},[170,171],-86.78444,36.16589,{"lat":171,"lon":170},[174,178,179],{"name":175,"role":51,"phone":176,"phoneExt":53,"email":177},"Sapna Gangaputra, MD MPH","615-936-3921","sapna.gangaputra@vumc.org",{"name":175,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":180,"role":48,"phone":53,"phoneExt":53,"email":53},"Thomas (Brent) Graham, MD MS",{"facility":182,"status":53,"city":183,"state":184,"zip":185,"country":61,"countryCode":62,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"University of Texas, Austin","Austin","Texas","78712",{"type":64,"coordinates":187},[188,189],-97.74306,30.26715,{"lat":189,"lon":188},[192,196],{"name":193,"role":51,"phone":194,"phoneExt":53,"email":195},"Eric Crowell, MD MPH","512-495-5899","eric.crowell@austin.utexas.edu",{"name":193,"role":48,"phone":53,"phoneExt":53,"email":53},{"facility":198,"status":53,"city":199,"state":200,"zip":201,"country":61,"countryCode":62,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"University of Utah Health","Salt Lake City","Utah","84132",{"type":64,"coordinates":203},[204,205],-111.89105,40.76078,{"lat":205,"lon":204},[208,212],{"name":209,"role":51,"phone":210,"phoneExt":53,"email":211},"Marissa Larochelle, MD","801-581-2352","marissa.larochelle@hsc.utah.edu",{"name":209,"role":48,"phone":53,"phoneExt":53,"email":53},{"facility":214,"status":53,"city":215,"state":53,"zip":216,"country":217,"countryCode":218,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Meyer Children's Hospital","Florence","50139","Italy","IT",{"type":64,"coordinates":220},[221,222],11.24626,43.77925,{"lat":222,"lon":221},[225,229,230],{"name":226,"role":51,"phone":227,"phoneExt":53,"email":228},"Gabriele Simonini","(+39) 05 55662924","gabriele.simonini@unifi.it",{"name":226,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":231,"role":48,"phone":53,"phoneExt":53,"email":53},"Ilaria Maccora",{"facility":233,"status":53,"city":234,"state":53,"zip":235,"country":236,"countryCode":237,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"University Hospitals Bristol and Weston","Bristol","BS1 3NU","United Kingdom","UK",{"type":64,"coordinates":239},[240,241],-2.59665,51.45523,{"lat":241,"lon":240},[244,248,249],{"name":245,"role":51,"phone":246,"phoneExt":53,"email":247},"A V Ramanan","+44 117 3420149","avramanan@hotmail.com",{"name":245,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":250,"role":48,"phone":53,"phoneExt":53,"email":53},"Catherine Guly",{"facility":252,"status":53,"city":253,"state":53,"zip":254,"country":236,"countryCode":237,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"University Hospitals of Leicester","Leicester","LE1 5WW",{"type":64,"coordinates":256},[257,258],-1.13169,52.6386,{"lat":258,"lon":257},[261,264,265],{"name":262,"role":51,"phone":53,"phoneExt":53,"email":263},"Arani Sridhar","arani.sridhar@uhl-tr.nhs.uk",{"name":262,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":266,"role":48,"phone":53,"phoneExt":53,"email":53},"Bharat Kapoor",{"facility":268,"status":53,"city":269,"state":53,"zip":270,"country":236,"countryCode":237,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"Alder Hey Children's Hospital","Liverpool","L14 5AB",{"type":64,"coordinates":272},[273,274],-2.97794,53.41058,{"lat":274,"lon":273},[277,281,282],{"name":278,"role":51,"phone":279,"phoneExt":53,"email":280},"Jose Gonzalez-Martin","+44 151 752 5839","Jose.Gonzalez-Martin@alderhey.nhs.uk",{"name":278,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":283,"role":48,"phone":53,"phoneExt":53,"email":53},"Gavin Cleary",{"facility":285,"status":53,"city":286,"state":53,"zip":287,"country":236,"countryCode":237,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Great Ormond Street Hospital","London","WC1N 3JH",{"type":64,"coordinates":289},[290,291],-0.12574,51.50853,{"lat":291,"lon":290},[294,297,298,300],{"name":295,"role":51,"phone":53,"phoneExt":53,"email":296},"Elena Moraitis","elena.moraitis@gosh.nhs.uk",{"name":295,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":299,"role":48,"phone":53,"phoneExt":53,"email":53},"Harry Petrushkin",{"name":301,"role":107,"phone":53,"phoneExt":53,"email":53},"Lola Solebo",{"facility":303,"status":53,"city":304,"state":53,"zip":305,"country":236,"countryCode":237,"cosmosGeoPoint":306,"geoPoint":310,"contacts":311},"Manchester University NHS Foundation Trust","Manchester","M13 9WL",{"type":64,"coordinates":307},[308,309],-2.23743,53.48095,{"lat":309,"lon":308},[312,316],{"name":313,"role":51,"phone":314,"phoneExt":53,"email":315},"Jane Ashworth","+44 794 461 6005","jane.ashworth@mft.nhs.uk",{"name":313,"role":48,"phone":53,"phoneExt":53,"email":53},{"facility":318,"status":53,"city":319,"state":53,"zip":320,"country":236,"countryCode":237,"cosmosGeoPoint":321,"geoPoint":325,"contacts":326},"Great North Children's Hospital","Newcastle upon Tyne","NE1 4LP",{"type":64,"coordinates":322},[323,324],-1.61396,54.97328,{"lat":324,"lon":323},[327,331],{"name":328,"role":51,"phone":329,"phoneExt":53,"email":330},"Sharmila Jandial","+44 191 282 5318","Sharmila.Jandial@nhs.net",{"name":328,"role":48,"phone":53,"phoneExt":53,"email":53},{"facility":333,"status":53,"city":334,"state":53,"zip":335,"country":236,"countryCode":237,"cosmosGeoPoint":336,"geoPoint":340,"contacts":341},"Norfolk and Norwich University Hospital","Norwich","NR4 6TZ",{"type":64,"coordinates":337},[338,339],1.29834,52.62783,{"lat":339,"lon":338},[342,346,347],{"name":343,"role":51,"phone":344,"phoneExt":53,"email":345},"Narman Puvanachandra","+44 1603288374","narman.puvanachandra@nnuh.nhs.uk",{"name":343,"role":48,"phone":53,"phoneExt":53,"email":53},{"name":348,"role":48,"phone":53,"phoneExt":53,"email":53},"Kate Armon",{"facility":350,"status":53,"city":351,"state":53,"zip":352,"country":236,"countryCode":237,"cosmosGeoPoint":353,"geoPoint":357,"contacts":53},"Sheffield Children's Hospital","Sheffield","S10 2TQ",{"type":64,"coordinates":354},[355,356],-1.4659,53.38297,{"lat":356,"lon":355},{"type":359,"investigatorFullName":360,"investigatorTitle":361,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"SPONSOR_INVESTIGATOR","Nisha Acharya","Principal Investigator",[363,366,368,369,370,371,373,375,376,378,380,381,383,385,387,389,391,393,395,397,399],{"name":364,"class":365},"National Eye Institute (NEI)","NIH",{"name":367,"class":365},"National Institutes of Health (NIH)",{"name":5,"class":6},{"name":76,"class":6},{"name":57,"class":6},{"name":372,"class":6},"Children's Hospital Medical Center, Cincinnati",{"name":374,"class":6},"Children's Mercy Hospital Kansas City",{"name":111,"class":6},{"name":377,"class":6},"University of Utah",{"name":379,"class":6},"University of Texas at Austin",{"name":164,"class":6},{"name":382,"class":6},"University Hospitals Bristol and Weston NHS Foundation Trust",{"name":384,"class":6},"Alder Hey Children's NHS Foundation Trust",{"name":386,"class":6},"Great Ormond Street Hospital for Children NHS Foundation Trust",{"name":388,"class":6},"Norfolk and Norwich University Hospitals NHS Foundation Trust",{"name":303,"class":390},"OTHER_GOV",{"name":392,"class":6},"Sheffield Children's NHS Foundation Trust",{"name":394,"class":6},"University Hospitals, Leicester",{"name":396,"class":6},"Meyer Children's Hospital IRCCS",{"name":398,"class":6},"Newcastle-upon-Tyne Hospitals NHS Trust",{"name":400,"class":6},"Moorfields Eye Hospital NHS Foundation Trust","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":411,"type":412},160,"ESTIMATED","INTERVENTIONAL",[415],"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.",[418,419],"Juvenile Idiopathic Arthritis Associated Uveitis","Uveitis, Anterior",[421,422,423,424],"Adalimumab","JIA-associated uveitis","Chronic anterior uveitis","reduced frequency dosing","NOT_YET_RECRUITING","2026-07-07",{"date":428,"type":429},"2026-07-13","ACTUAL",{"date":431,"type":412},"2026-09",{"date":433,"type":412},"2030-11",{"name":360,"class":6},18]