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| ID | Type | Description | Link |
|---|---|---|---|
| UG1EY038172 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| National Institutes of Health (NIH) | NIH |
| University of California, San Francisco | OTHER |
| University of California, Davis |
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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.
The main question it aims to answer is: can adalimumab/biosimilar injections be given less frequently without uveitis (eye inflammation) or arthritis (joint inflammation) returning?
Researchers will compare adalimumab/biosimilar injection schedules of every 2 weeks, 4 weeks, 8 weeks, and 12 weeks to determine how injection frequency affects disease control.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-Week Dose | Active Comparator | Participants receive adalimumab/biosimilar at their current weight-based dose every 2 weeks for 24 weeks, continuing in accordance with current standard of care practice. |
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| 4-Week Dose | Experimental | Participants receive adalimumab/biosimilar at their current weight-based dose every 4 weeks for 24 weeks. |
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| 8-Week Dose | Experimental | Participants receive adalimumab/biosimilar at their current weight-based dose every 8 weeks for 24 weeks. |
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| 12-Week Dose | Experimental | Participants receive adalimumab/biosimilar at their current weight-based dose every 12 weeks for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab/Biosimilar | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Treatment Failure | Proportion of participants in each treatment arm experiencing treatment failure by Week 24. Treatment failure is defined by recurrence of ocular inflammation (at least one of the following in at least one eye):
Treatment 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nisha Acharya, MD MS | Contact | 415-476-8131 | Nisha.Acharya@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nisha Acharya, MD MS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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/annrheumdis-2017-212089. Epub 2017 Dec 23. | |
| 37734639 | Background | 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/j.ajo.2023.09.012. Epub 2023 Sep 19. |
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| OTHER |
| University of California, Los Angeles | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Children's Mercy Hospital Kansas City | OTHER |
| University of Miami | OTHER |
| University of Utah | OTHER |
| University of Texas at Austin | OTHER |
| Vanderbilt University Medical Center | OTHER |
| University Hospitals Bristol and Weston NHS Foundation Trust | OTHER |
| Alder Hey Children's NHS Foundation Trust | OTHER |
| Great Ormond Street Hospital for Children NHS Foundation Trust | OTHER |
| Norfolk and Norwich University Hospitals NHS Foundation Trust | OTHER |
| Manchester University NHS Foundation Trust | OTHER_GOV |
| Sheffield Children's NHS Foundation Trust | OTHER |
| University Hospitals, Leicester | OTHER |
| Meyer Children's Hospital IRCCS | OTHER |
| Newcastle-upon-Tyne Hospitals NHS Trust | OTHER |
| Moorfields Eye Hospital NHS Foundation Trust | OTHER |
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|
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| University of California, Davis | Sacramento | California | 95817 | United States |
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| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| University of Miami | Miami | Florida | 33136 | United States |
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| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
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| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
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| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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| University of Texas, Austin | Austin | Texas | 78712 | United States |
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| University of Utah Health | Salt Lake City | Utah | 84132 | United States |
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| Meyer Children's Hospital | Florence | 50139 | Italy |
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| University Hospitals Bristol and Weston | Bristol | BS1 3NU | United Kingdom |
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| University Hospitals of Leicester | Leicester | LE1 5WW | United Kingdom |
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| Alder Hey Children's Hospital | Liverpool | L14 5AB | United Kingdom |
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| Great Ormond Street Hospital | London | WC1N 3JH | United Kingdom |
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| Manchester University NHS Foundation Trust | Manchester | M13 9WL | United Kingdom |
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| Great North Children's Hospital | Newcastle upon Tyne | NE1 4LP | United Kingdom |
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| Norfolk and Norwich University Hospital | Norwich | NR4 6TZ | United Kingdom |
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| Sheffield Children's Hospital | Sheffield | S10 2TQ | United Kingdom |
| 28445659 | Background | 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/NEJMoa1614160. |
| 39863370 | Background | 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/S0140-6736(24)02468-1. |
| ID | Term |
|---|---|
| D014606 | Uveitis, Anterior |
| D015867 | Uveitis, Intermediate |
| ID | Term |
|---|---|
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D059451 | Biosimilar Pharmaceuticals |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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