Juvenile Idiopathic Arthritis Associated UveitisPhase 4ADAPTNCT07699107
Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial
A Phase 4 study testing Adalimumab/Biosimilar in people with Juvenile Idiopathic Arthritis Associated Uveitis and Uveitis, Anterior, run by Nisha Acharya at 18 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Juvenile Idiopathic Arthritis Associated Uveitis, Uveitis, Anterior
- What is being tested?
- Adalimumab/Biosimilar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Sep 2026to Nov 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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/choroidal lesions in either eye)
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- ≥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 <30kg), 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/biosimilar per regional labeling
Who cannot join
- 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 (<5mmHg 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
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- 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/enrollment: leukocyte count <2500, platelet count ≤75000, hemoglobin<9.0, aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 2 times the upper limit of normal range, creatinine ≥1.5
Trial locations and contacts
18 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 3 countries
United States9 sites
University of Texas, Austin
Austin, Texas, 78712
Eric Crowell, MD MPH, 512-495-5899, eric.crowell@austin.utexas.edu
Eric Crowell, MD MPH
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Sheila Angeles-Han, MD, 513-517-2057, Sheila.Angeles-Han@cchmc.org
Sheila Angeles-Han, MD
Children's Mercy Hospital
Kansas City, Missouri, 64108
Erin Stahl, MD, 816-960-8000, edstahl@cmh.edu
Erin Stahl, MD
University of California, Los Angeles
Los Angeles, California, 90095
Edmund Tsui, MD, 310-825-5440, etsui@mednet.ucla.edu
Edmund Tsui, MD
University of Miami
Miami, Florida, 33136
Stephanie Llop, MD, sxl1789@med.miami.edu
Stephanie Llop, MD
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Sapna Gangaputra, MD MPH, 615-936-3921, sapna.gangaputra@vumc.org
Sapna Gangaputra, MD MPH
University of California, Davis
Sacramento, California, 95817
Parisa Emami-Naeini, MD, MPH, 916-734-6602, parisaemami@gmail.com
Parisa Emami-Naeini, MD MPH
University of Utah Health
Salt Lake City, Utah, 84132
Marissa Larochelle, MD, 801-581-2352, marissa.larochelle@hsc.utah.edu
Marissa Larochelle, MD
University of California, San Francisco
San Francisco, California, 94143
Nisha Acharya, MD MS, 415-476-8131, Nisha.Acharya@ucsf.edu
Nisha Acharya, MD
United Kingdom8 sites
University Hospitals Bristol and Weston
Bristol, BS1 3NU
A V Ramanan, +44 117 3420149, avramanan@hotmail.com
A V Ramanan
University Hospitals of Leicester
Leicester, LE1 5WW
Arani Sridhar, arani.sridhar@uhl-tr.nhs.uk
Arani Sridhar
Alder Hey Children's Hospital
Liverpool, L14 5AB
Jose Gonzalez-Martin, +44 151 752 5839, Jose.Gonzalez-Martin@alderhey.nhs.uk
Jose Gonzalez-Martin
Great Ormond Street Hospital
London, WC1N 3JH
Elena Moraitis, elena.moraitis@gosh.nhs.uk
Elena Moraitis
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Jane Ashworth, +44 794 461 6005, jane.ashworth@mft.nhs.uk
Jane Ashworth
Great North Children's Hospital
Newcastle upon Tyne, NE1 4LP
Sharmila Jandial, +44 191 282 5318, Sharmila.Jandial@nhs.net
Sharmila Jandial
Norfolk and Norwich University Hospital
Norwich, NR4 6TZ
Narman Puvanachandra, +44 1603288374, narman.puvanachandra@nnuh.nhs.uk
Narman Puvanachandra
Sheffield Children's Hospital
Sheffield, S10 2TQ
Italy1 site
Meyer Children's Hospital
Florence, 50139
Gabriele Simonini, (+39) 05 55662924, gabriele.simonini@unifi.it
Gabriele Simonini
About this study
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?
Read more
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:
- Take adalimumab/biosimilar injections every 2, 4, 8, or 12 weeks.
- Attend study visits every 6 weeks over 24 weeks, with an additional follow-up visit at 48 weeks for checkups, tests, and questionnaires.
- Keep a diary of how often they take adalimumab/biosimilar and other drugs they take for their uveitis/arthritis.
- Being tested
- Adalimumab/Biosimilar
- Keywords
- Adalimumab, JIA-associated uveitis, Chronic anterior uveitis, reduced frequency dosing
- Medical subject headings
- Uveitis, Anterior, Uveitis, Intermediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab/BiosimilarBiological
Also called Humira, Abrilada, Amjevita, Cyltezo
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Adalimumab/Biosimilar |
| 4-Week Dose | Experimental | Participants receive adalimumab/biosimilar at their current weight-based dose every 4 weeks for 24 weeks. Receives: Biological: Adalimumab/Biosimilar |
| 8-Week Dose | Experimental | Participants receive adalimumab/biosimilar at their current weight-based dose every 8 weeks for 24 weeks. Receives: Biological: Adalimumab/Biosimilar |
| 12-Week Dose | Experimental | Participants receive adalimumab/biosimilar at their current weight-based dose every 12 weeks for 24 weeks. Receives: Biological: Adalimumab/Biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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):
- >0.5+ anterior chamber (AC) cell at a single visit as defined by the Standardization of Uveitis Nomenclature (SUN) criteria
- >0.5+ vitreous haze at a single visit
- Active retinal/choroidal inflammation and/or 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/or presence of intraretinal or subretinal fluid.
Treatment failure may also be defined as recurrence of joint disease persistent and severe enough to necessitate unmasking to manage the arthritis recurrence.
Measured: From baseline to 24 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic Arthritis Associated UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nisha Acharya
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), National Institutes of Health (NIH), University of California, San Francisco, University of California, Davis, University of California, Los Angeles, Children's Hospital Medical Center, Cincinnati, Children's Mercy Hospital Kansas City, University of Miami, University of Utah, University of Texas at Austin, Vanderbilt University Medical Center, University Hospitals Bristol and Weston NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust, Sheffield Children's NHS Foundation Trust, University Hospitals, Leicester, Meyer Children's Hospital IRCCS, Newcastle-upon-Tyne Hospitals NHS Trust, Moorfields Eye Hospital NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Nisha Acharya, University of California, San Francisco
- Investigators
- Nisha Acharya, MD MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699107
- Sponsor's protocol ID
- 25-45347
- Other IDs
- UG1EY038172
- Acronym
- ADAPT
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29275333Pichi 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.
PubMed 37734639Ramanan 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.
PubMed 28445659Acharya 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.
PubMed 39863370
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial
- ClinicalTrials.gov ID
- NCT07699107
- Acronym / sponsor ID
- ADAPT / 25-45347
- Keywords
- Adalimumab, JIA-associated uveitis, Chronic anterior uveitis, reduced frequency dosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Nisha AcharyaUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), National Institutes of Health (NIH), University of California, San Francisco, University of California, Davis, University of California, Los Angeles, Children's Hospital Medical Center, Cincinnati, Children's Mercy Hospital Kansas City, University of Miami, University of Utah, University of Texas at Austin, Vanderbilt University Medical Center, University Hospitals Bristol and Weston NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust, Sheffield Children's NHS Foundation Trust, University Hospitals, Leicester, Meyer Children's Hospital IRCCS, Newcastle-upon-Tyne Hospitals NHS Trust, Moorfields Eye Hospital NHS Foundation Trust
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Take adalimumab/biosimilar injections every 2, 4, 8, or 12 weeks.
- Attend study visits every 6 weeks over 24 weeks, with an additional follow-up visit at 48 weeks for checkups, tests, and questionnaires.
- Keep a diary of how often they take adalimumab/biosimilar and other drugs they take for their uveitis/arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2-Week Dose | Active comparator | Biological: Adalimumab/BiosimilarParticipants receive adalimumab/biosimilar at their current weight-based dose every 2 weeks for 24 weeks, continuing in accordance with current standard of care practice. |
| 4-Week Dose | Experimental | Biological: Adalimumab/BiosimilarParticipants receive adalimumab/biosimilar at their current weight-based dose every 4 weeks for 24 weeks. |
| 8-Week Dose | Experimental | Biological: Adalimumab/BiosimilarParticipants receive adalimumab/biosimilar at their current weight-based dose every 8 weeks for 24 weeks. |
| 12-Week Dose | Experimental | Biological: Adalimumab/BiosimilarParticipants receive adalimumab/biosimilar at their current weight-based dose every 12 weeks for 24 weeks. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (13 listed)
- 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 (<5mmHg for ≥90 days) in either eye
- Treatment with oral corticosteroids or intraocular corticosteroid injection within the last 24 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalimumab/BiosimilarAlso: Humira, Abrilada, Amjevita, CyltezoAdalimumab 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). | Biological | 12-Week Dose, 2-Week Dose, 4-Week Dose, 8-Week Dose |
Primary outcome
Cumulative Incidence of Treatment Failure
Time frame: From baseline to 24 weeks post-randomization
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): * >0.5+ anterior chamber (AC) cell at a single visit as defined by the Standardization of Uveitis Nomenclature (SUN) criteria * >0.5+ vitreous haze at a single visit * Active retinal/choroidal inflammation and/or 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/or presence of intraretinal or subretinal fluid. Treatment failure may also be defined as recurrence of joint disease persistent and severe enough to necessitate unmasking to manage the arthritis recurrence.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 29275333Quartier 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.
- Background: PubMed 37734639Pichi 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.
- Background: PubMed 28445659Ramanan 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.
- Background: PubMed 39863370Acharya 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.
- Individual participant dataSharing planned: No
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Uveitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nisha Acharya, MD MS principal investigator
University of California, San Francisco
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab/Biosimilar in people with Juvenile Idiopathic Arthritis Associated Uveitis and Uveitis, Anterior, run by Nisha Acharya at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, United Kingdom, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nisha Acharya, MD MS (415-476-8131, Nisha.Acharya@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Treatment Failure (time frame: From baseline to 24 weeks post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07699107, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.