[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07699107":3,"trial-entities:NCT07699107":388,"trial-summary:NCT07699107":392},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":54,"secondary_outcomes":59,"sex":60,"minimum_age":61,"maximum_age":16,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":96,"locations":100,"central_contacts":369,"overall_officials":371,"references":373,"see_also_links":387},"NCT07699107","25-45347","Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial","NOT_YET_RECRUITING","2030-11","2026-07","2026-07-13","2026-09","Nisha Acharya","OTHER",true,"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.",null,[18,19],"Juvenile Idiopathic Arthritis Associated Uveitis","Uveitis, Anterior",[21,22,23,24],"Adalimumab","JIA-associated uveitis","Chronic anterior uveitis","reduced frequency dosing","INTERVENTIONAL","TREATMENT",[28],"PHASE4",{"count":30,"type":31},160,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":42},"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).",[38,39,40,41],"12-Week Dose","2-Week Dose","4-Week Dose","8-Week Dose",[43,44,45,46,47,48,49,50,51,52,53],"Humira","Abrilada","Amjevita","Cyltezo","Hadlima","Hulio","Hyrimoz","Idacio","Simlandi","Yuflyma","Yusimry",[55],{"measure":56,"description":57,"timeFrame":58},"Cumulative Incidence of Treatment Failure","Proportion of participants in each treatment arm experiencing treatment failure by Week 24.\n\nTreatment failure is defined by recurrence of ocular inflammation (at least one of the following in at least one eye):\n\n* \\>0.5+ anterior chamber (AC) cell at a single visit as defined by the Standardization of Uveitis Nomenclature (SUN) criteria\n* \\>0.5+ vitreous haze at a single visit\n* Active retinal\u002Fchoroidal inflammation and\u002For macular edema in either eye at a single visit. Macular edema is defined as central subfield thickness on optical coherence tomography (OCT) \\>2 standard deviations above normal thickness (\\>320µm on Spectralis or \\>300µm on Zeiss or Topcon) and having a greater than 20% increase from baseline and\u002For presence of intraretinal or subretinal fluid.\n\nTreatment failure may also be defined as recurrence of joint disease persistent and severe enough to necessitate unmasking to manage the arthritis recurrence.","From baseline to 24 weeks post-randomization",[],"ALL","2 Years",false,{"inclusion":64,"exclusion":81,"raw_text":95},[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80],"Stated willingness to comply with all study procedures and availability for the duration of the study period","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)","≥2 years of age (per FDA approval for use in children with polyarticular JIA)","Weight must be ≥15kg","Formal diagnosis of JIA-associated uveitis or CAU with no other suspected etiology","≥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)","≥24 consecutive months of controlled arthritis verified by a pediatric rheumatologist if defined as JIA-associated uveitis","≥24 consecutive months of treatment with adalimumab or biosimilar of adalimumab","≥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","If on biosimilar of adalimumab, ≥90 days on the biosimilar","Ability to continue to obtain commercial supply of adalimumab or biosimilar","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","Willingness to limit consumption of alcohol during the study period","Agreement to avoid live attenuated vaccinations","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)","Suitable, in the opinion of the Investigator, to continue treatment with adalimumab\u002Fbiosimilar per regional labeling",[82,83,84,85,86,87,88,89,90,91,92,93,94],"History of acute anterior uveitis characterized by redness and symptoms, including but not limited to floaters, pain, and light sensitivity","Intraocular surgery in the past 90 days or planned surgery in the next 24 weeks","Severe cataract or opacity preventing view to the posterior pole in both eyes","Chronic hypotony (\\\u003C5mmHg for ≥90 days) in either eye","Treatment with oral corticosteroids or intraocular corticosteroid injection within the last 24 weeks","Use of topical corticosteroid eye drops within the last 90 days","Use of nonsteroidal anti-inflammatory drug (NSAID) eye drops within the last 90 days","Pregnancy or lactation (a pregnancy test will be conducted at baseline and follow-up visits for females post-menarche)","Presence of intraretinal or subretinal fluid in either eye","Prior safety or tolerability issues with adalimumab","History of cancer, active tuberculosis, or hepatitis B","Other medical condition expected to dictate treatment course during the study","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","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",[97,98,99],"CHILD","ADULT","OLDER_ADULT",[101,118,134,153,168,184,200,216,230,244,260,276,290,305,321,334,347,362],{"facility":102,"city":103,"state":104,"zip":105,"country":106,"contacts":107,"geoPoint":115},"University of California, Los Angeles","Los Angeles","California","90095","United States",[108,113],{"name":109,"role":110,"phone":111,"email":112},"Edmund Tsui, MD","CONTACT","310-825-5440","etsui@mednet.ucla.edu",{"name":109,"role":114},"PRINCIPAL_INVESTIGATOR",{"lat":116,"lon":117},34.05223,-118.24368,{"facility":119,"city":120,"state":104,"zip":121,"country":106,"contacts":122,"geoPoint":131},"University of California, Davis","Sacramento","95817",[123,127,129],{"name":124,"role":110,"phone":125,"email":126},"Parisa Emami-Naeini, MD, MPH","916-734-6602","parisaemami@gmail.com",{"name":128,"role":114},"Parisa Emami-Naeini, MD MPH",{"name":130,"role":114},"Angel Herrera-Guerra, MD PhD",{"lat":132,"lon":133},38.58157,-121.4944,{"facility":135,"city":136,"state":104,"zip":137,"country":106,"contacts":138,"geoPoint":150},"University of California, San Francisco","San Francisco","94143",[139,143,145,148],{"name":140,"role":110,"phone":141,"email":142},"Nisha Acharya, MD MS","415-476-8131","Nisha.Acharya@ucsf.edu",{"name":144,"role":114},"Nisha Acharya, MD",{"name":146,"role":147},"Thuy Doan, MD PhD","SUB_INVESTIGATOR",{"name":149,"role":147},"John Gonzales, MD",{"lat":151,"lon":152},37.77493,-122.41942,{"facility":154,"city":155,"state":156,"zip":157,"country":106,"contacts":158,"geoPoint":165},"University of Miami","Miami","Florida","33136",[159,162,163],{"name":160,"role":110,"email":161},"Stephanie Llop, MD","sxl1789@med.miami.edu",{"name":160,"role":114},{"name":164,"role":147},"Janet Davis, MD",{"lat":166,"lon":167},25.77427,-80.19366,{"facility":169,"city":170,"state":171,"zip":172,"country":106,"contacts":173,"geoPoint":181},"Children's Mercy Hospital","Kansas City","Missouri","64108",[174,178,179],{"name":175,"role":110,"phone":176,"email":177},"Erin Stahl, MD","816-960-8000","edstahl@cmh.edu",{"name":175,"role":114},{"name":180,"role":114},"Ashley Cooper, MD",{"lat":182,"lon":183},39.09973,-94.57857,{"facility":185,"city":186,"state":187,"zip":188,"country":106,"contacts":189,"geoPoint":197},"Cincinnati Children's Hospital","Cincinnati","Ohio","45229",[190,194,195],{"name":191,"role":110,"phone":192,"email":193},"Sheila Angeles-Han, MD","513-517-2057","Sheila.Angeles-Han@cchmc.org",{"name":191,"role":114},{"name":196,"role":114},"Virginia Miraldi Utz, MD",{"lat":198,"lon":199},39.12711,-84.51439,{"facility":201,"city":202,"state":203,"zip":204,"country":106,"contacts":205,"geoPoint":213},"Vanderbilt University Medical Center","Nashville","Tennessee","37212",[206,210,211],{"name":207,"role":110,"phone":208,"email":209},"Sapna Gangaputra, MD MPH","615-936-3921","sapna.gangaputra@vumc.org",{"name":207,"role":114},{"name":212,"role":114},"Thomas (Brent) Graham, MD MS",{"lat":214,"lon":215},36.16589,-86.78444,{"facility":217,"city":218,"state":219,"zip":220,"country":106,"contacts":221,"geoPoint":227},"University of Texas, Austin","Austin","Texas","78712",[222,226],{"name":223,"role":110,"phone":224,"email":225},"Eric Crowell, MD MPH","512-495-5899","eric.crowell@austin.utexas.edu",{"name":223,"role":114},{"lat":228,"lon":229},30.26715,-97.74306,{"facility":231,"city":232,"state":233,"zip":234,"country":106,"contacts":235,"geoPoint":241},"University of Utah Health","Salt Lake City","Utah","84132",[236,240],{"name":237,"role":110,"phone":238,"email":239},"Marissa Larochelle, MD","801-581-2352","marissa.larochelle@hsc.utah.edu",{"name":237,"role":114},{"lat":242,"lon":243},40.76078,-111.89105,{"facility":245,"city":246,"zip":247,"country":248,"contacts":249,"geoPoint":257},"Meyer Children's Hospital","Florence","50139","Italy",[250,254,255],{"name":251,"role":110,"phone":252,"email":253},"Gabriele Simonini","(+39) 05 55662924","gabriele.simonini@unifi.it",{"name":251,"role":114},{"name":256,"role":114},"Ilaria Maccora",{"lat":258,"lon":259},43.77925,11.24626,{"facility":261,"city":262,"zip":263,"country":264,"contacts":265,"geoPoint":273},"University Hospitals Bristol and Weston","Bristol","BS1 3NU","United Kingdom",[266,270,271],{"name":267,"role":110,"phone":268,"email":269},"A V Ramanan","+44 117 3420149","avramanan@hotmail.com",{"name":267,"role":114},{"name":272,"role":114},"Catherine Guly",{"lat":274,"lon":275},51.45523,-2.59665,{"facility":277,"city":278,"zip":279,"country":264,"contacts":280,"geoPoint":287},"University Hospitals of Leicester","Leicester","LE1 5WW",[281,284,285],{"name":282,"role":110,"email":283},"Arani Sridhar","arani.sridhar@uhl-tr.nhs.uk",{"name":282,"role":114},{"name":286,"role":114},"Bharat Kapoor",{"lat":288,"lon":289},52.6386,-1.13169,{"facility":291,"city":292,"zip":293,"country":264,"contacts":294,"geoPoint":302},"Alder Hey Children's Hospital","Liverpool","L14 5AB",[295,299,300],{"name":296,"role":110,"phone":297,"email":298},"Jose Gonzalez-Martin","+44 151 752 5839","Jose.Gonzalez-Martin@alderhey.nhs.uk",{"name":296,"role":114},{"name":301,"role":114},"Gavin Cleary",{"lat":303,"lon":304},53.41058,-2.97794,{"facility":306,"city":307,"zip":308,"country":264,"contacts":309,"geoPoint":318},"Great Ormond Street Hospital","London","WC1N 3JH",[310,313,314,316],{"name":311,"role":110,"email":312},"Elena Moraitis","elena.moraitis@gosh.nhs.uk",{"name":311,"role":114},{"name":315,"role":114},"Harry Petrushkin",{"name":317,"role":147},"Lola Solebo",{"lat":319,"lon":320},51.50853,-0.12574,{"facility":322,"city":323,"zip":324,"country":264,"contacts":325,"geoPoint":331},"Manchester University NHS Foundation Trust","Manchester","M13 9WL",[326,330],{"name":327,"role":110,"phone":328,"email":329},"Jane Ashworth","+44 794 461 6005","jane.ashworth@mft.nhs.uk",{"name":327,"role":114},{"lat":332,"lon":333},53.48095,-2.23743,{"facility":335,"city":336,"zip":337,"country":264,"contacts":338,"geoPoint":344},"Great North Children's Hospital","Newcastle upon Tyne","NE1 4LP",[339,343],{"name":340,"role":110,"phone":341,"email":342},"Sharmila Jandial","+44 191 282 5318","Sharmila.Jandial@nhs.net",{"name":340,"role":114},{"lat":345,"lon":346},54.97328,-1.61396,{"facility":348,"city":349,"zip":350,"country":264,"contacts":351,"geoPoint":359},"Norfolk and Norwich University Hospital","Norwich","NR4 6TZ",[352,356,357],{"name":353,"role":110,"phone":354,"email":355},"Narman Puvanachandra","+44 1603288374","narman.puvanachandra@nnuh.nhs.uk",{"name":353,"role":114},{"name":358,"role":114},"Kate Armon",{"lat":360,"lon":361},52.62783,1.29834,{"facility":363,"city":364,"zip":365,"country":264,"geoPoint":366},"Sheffield Children's Hospital","Sheffield","S10 2TQ",{"lat":367,"lon":368},53.38297,-1.4659,[370],{"name":140,"role":110,"phone":141,"email":142},[372],{"name":140,"affiliation":135,"role":114},[374,378,381,384],{"pmid":375,"type":376,"citation":377},"29275333","BACKGROUND","Quartier P, Baptiste A, Despert V, Allain-Launay E, Kone-Paut I, Belot A, Kodjikian L, Monnet D, Weber M, Elie C, Bodaghi B; ADJUVITE Study Group. ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis. Ann Rheum Dis. 2018 Jul;77(7):1003-1011. doi: 10.1136\u002Fannrheumdis-2017-212089. Epub 2017 Dec 23.",{"pmid":379,"type":376,"citation":380},"37734639","Pichi F, Smith SD, Goldstein DA, Baddar D, Gerges TKA, Janetos TM, Ruiz-Cruz M, Elena Concha-Del-Rio L, Maruyama K, Carina Ten Berge J, Rombach SM, Cimino L, Bolletta E, Miserocchi E, Scandale P, Serafino M, Camicione P, Androudi S, Gonzalez-Lopez JJ, Lim LL, Singh N, Gupta V, Gupta N, Amer R, Dodds EM, Inchauspe S, Munk MR, Donicova E, Carreno E, Takeuchi M, Chee SP, Chew MC, Agarwal A, Schlaen A, Gomez RA, Couto CA, Khairallah M, Neri P. The Humira in Ocular Inflammations Taper (HOT) Study. Am J Ophthalmol. 2024 Feb;258:87-98. doi: 10.1016\u002Fj.ajo.2023.09.012. Epub 2023 Sep 19.",{"pmid":382,"type":376,"citation":383},"28445659","Ramanan AV, Dick AD, Jones AP, McKay A, Williamson PR, Compeyrot-Lacassagne S, Hardwick B, Hickey H, Hughes D, Woo P, Benton D, Edelsten C, Beresford MW; SYCAMORE Study Group. Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis. N Engl J Med. 2017 Apr 27;376(17):1637-1646. doi: 10.1056\u002FNEJMoa1614160.",{"pmid":385,"type":376,"citation":386},"39863370","Acharya NR, Ramanan AV, Coyne AB, Dudum KL, Rubio EM, Woods SM, Guly CM, Moraitis E, Petrushkin HJD, Armon K, Puvanachandra N, Choi JT, Hawley DP, Arnold BF; ADJUST Study Group. Stopping of adalimumab in juvenile idiopathic arthritis-associated uveitis (ADJUST): a multicentre, double-masked, randomised controlled trial. Lancet. 2025 Jan 25;405(10475):303-313. doi: 10.1016\u002FS0140-6736(24)02468-1.",[],{"nct_id":4,"conditions":389,"biomarkers":391},[23,390],"Uveitis due to juvenile idiopathic arthritis",[],{"nct_id":4,"found":14,"summary":393,"prompt_version":403},{"design":394,"status":395,"heading":396,"summary":397,"follow_up":398,"word_count":399,"commitments":400,"compensation":401,"drugs_mentioned":402},"This is an interventional study planning to enroll 160 participants. It will compare different schedules for adalimumab\u002Fbiosimilar injections.","completed","Adalimumab Dose Adjustment for Pediatric Uveitis Treatment","This study is looking at whether children and young adults with well-controlled uveitis (eye inflammation) linked to juvenile idiopathic arthritis (JIA) or chronic anterior uveitis can safely take adalimumab (or a similar biosimilar medicine) less often. Adalimumab is an injectable medicine that helps control inflammation. Researchers want to see if giving injections every 2, 4, 8, or 12 weeks can still keep the disease under control, preventing eye or joint inflammation from returning. The study plans to enroll 160 participants aged 2 years and older who have a history of JIA or chronic anterior uveitis diagnosed before age 16. The main goal is to measure how often treatment failure occurs over 24 weeks.","The primary endpoint measures treatment failure from baseline to 24 weeks post-randomization.",113,"Participants will take adalimumab\u002Fbiosimilar injections every 2, 4, 8, or 12 weeks.","Not stated in the trial record.",[],"v2"]