UveitisPhase 4ADJUSTNCT03816397
Adalimumab in JIA-associated Uveitis Stopping Trial
A Phase 4 study testing Adalimumab in people with Uveitis and JIA, run by Nisha Acharya at 21 sites in 3 countries.
Trial summary
The proposed study is a stratified, block-randomized, double-masked, controlled trial to determine the feasibility of discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU). Read more about this study
- Who is it for?
- Ages 2 years and older
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 15 Mar 2020to 3 Apr 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
None listed.
Who cannot join
- Intraocular surgery in the past 90 days or planned surgery in the next 12 months
- Severe cataract or opacity preventing view to the posterior pole in both eyes
- Chronic hypotony (<5 mmHg for ≥90 days) in either eye
- Treatment with oral corticosteroids or intraocular corticosteroid injection within the last 12 months
- Use of NSAID eye drops within the last 90 days
- Acute anterior uveitis characterized by redness and symptoms, including but not limited to floaters, pain, and light sensitivity
Show all 13Show fewer
- Pregnancy or lactation (a pregnancy test will be conducted at baseline and all follow-up visits for females of reproductive age)
- 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 Aminotransferase (AST) or Alanine Transferase (ALT) ≥ 2 times the upper limit of normal range, creatinine ≥1.5
- There are no sex, race, or ethnicity restrictions for this study.
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States11 sites
University of Colorado Denver
Aurora, Colorado, 80045
University of Texas, Austin
Austin, Texas, 78712
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Children's Mercy Hospital
Kansas City, Missouri, 64108
Colorado Retina Associates
Lakewood, Colorado, 80228
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California, Davis
Sacramento, California, 95817
University of Utah Health
Salt Lake City, Utah, 84132
University of California, San Francisco
San Francisco, California, 94143
United Kingdom9 sites
University Hospitals Bristol and Weston
Bristol, BS1 3NU
Cambridge University Hospital
Cambridge
University Hospitals, Leicester
Leicester
Alder Hey Children's Hospital
Liverpool, L14 5AB
Great Ormond Street Hospital
London, WC1N 3JH
Manchester University NHS Foundation Trust
Manchester
Great North Children's Hospital
Newcastle upon Tyne, NE1 4LP
Norfolk and Norwich University Hospital
Norwich, NR4 6TZ
Sheffield Children's Hospital
Sheffield, S10 2TQ
Australia1 site
Murdoch Children's Research Institute
Parkville, Victoria, 3052
About this study
Official title: Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial
The proposed study is a stratified, block-randomized, double-masked, controlled trial to determine the feasibility of discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU).
Read the detailed description
Background: Juvenile idiopathic arthritis (JIA)-associated uveitis is a chronic pediatric ocular inflammatory condition that can result in visual impairment. Chronic anterior uveitis (CAU) does not have systemic manifestations of disease but presents similarly in the eye and can result in identical visual complications as JIA-associated uveitis. Adalimumab, a tumor necrosis factor (TNF) inhibitor, effectively controls joint and eye inflammation; however, its long-term use may increase the risk of adverse health outcomes and place an undue financial burden on the patient and healthcare system given its high cost. There is great interest for patients to stop adalimumab following remission due to these reasons but there is a lack of information on the ability to maintain control after discontinuing adalimumab.
Methods: The Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Trial (ADJUST) is a multi-center international trial that will randomize 118 participants aged 2 years and older with controlled JIA-associated uveitis or chronic anterior uveitis to either continue adalimumab or discontinue adalimumab and receive a placebo. The trial will compare the time to uveitis recurrence between the two groups over 12 months. All participants will receive the standard weight-based dose of adalimumab or placebo: 20 mg biweekly (if < 30 kg) or 40 mg biweekly (if ≥ 30 kg).
Impact: This is the first randomized controlled trial to assess the efficacy of discontinuing adalimumab after demonstrating control of JIA-associated uveitis for at least 12 months. The results of ADJUST will provide information on clinical outcomes to guide clinicians in their decision-making regarding discontinuation of adalimumab.
- Being tested
- Adalimumab, Placebo
- Keywords
- chronic anterior uveitis, adalimumab, JIA-associated uveitis, stopping
- Medical subject headings
- Uveitis, Uveitis, Intermediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Also called HUMIRA
Adalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody, a biologic, immunomodulatory drug. Adalimumab 20mg/0.8 mL and 40mg/0.8 mL is a clear, colorless solution provided in a pre-filled syringe for subcutaneous injection. The formulation is adalimumab, mannitol, polysorbate 80, and water for injection Each pre-filled syringe has a fixed 29-gauge thin wall and ½ inch needle with black protective cover and is intended for a single dose to a single patient.
PlaceboOther
The placebo solution is a clear, colorless solution provided in a single-use, pre-filled syringe for subcutaneous injection. The volume-matched (0.8mL) placebo is designed to match the characteristics of the citrate-free adalimumab during injection.
| Study group | Role | What they receive |
|---|---|---|
| Continue adalimumab | Active comparator | Patients randomized to this arm will continue adalimumab at their current weight-based dose administered subcutaneously every other week. Receives: Biological: Adalimumab |
| Stop adalimumab | Placebo comparator | Patients randomized to this arm will receive a volume-matched placebo administered subcutaneously every other week. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Failure
Treatment failure is defined by recurrence of ocular inflammation in at least one eye as follows:
- 3+ anterior chamber (AC) for a single visit •>0.5+ anterior chamber (AC) cell for ≥28 days
- 2-step increase in AC cell observed at two separate visits ≥7 days apart
- 0.5+ vitreous haze, active retinal or choroidal inflammation, or macular edema observed at a single visit. Treatment failure can also be declared by recurrence of joint inflammation that is persistent and severe enough to necessitate unmasking to manage the arthritis recurrence.
Time (days) from all participants is included in the analysis.
Measured: From baseline until 48 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 posted25 Jan 2019
- Study start15 Mar 2020
- Primary completion23 Jan 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nisha Acharya
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Children's Mercy Hospital Kansas City, National Eye Institute (NEI), Great Ormond Street Hospital for Children NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Sheffield Children's NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Royal Children's Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust, Vanderbilt University Medical Center, University of California, Davis, University of Texas at Austin, University of Miami, University Hospitals, Leicester, University of Utah, Colorado Retina Associates, Manchester University NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Nisha Acharya, University of California, San Francisco
- Investigators
- Nisha Acharya, MD MS, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816397
- Sponsor's protocol ID
- 17-23987
- Other IDs
- UG1EY029658
- Acronym
- ADJUST
- Status last verified
- May 2025
- First submitted
- 22 Jan 2019
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaffe GJ, Dick AD, Brezin AP, Nguyen QD, Thorne JE, Kestelyn P, Barisani-Asenbauer T, Franco P, Heiligenhaus A, Scales D, Chu DS, Camez A, Kwatra NV, Song AP, Kron M, Tari S, Suhler EB. Adalimumab in Patients with Active Noninfectious Uveitis. N Engl J Med. 2016 Sep 8;375(10):932-43. doi: 10.1056/NEJMoa1509852.
PubMed 27602665Nguyen QD, Merrill PT, Jaffe GJ, Dick AD, Kurup SK, Sheppard J, Schlaen A, Pavesio C, Cimino L, Van Calster J, Camez AA, Kwatra NV, Song AP, Kron M, Tari S, Brezin AP. Adalimumab for prevention of uveitic flare in patients with inactive non-infectious uveitis controlled by corticosteroids (VISUAL II): a multicentre, double-masked, randomised, placebo-controlled phase 3 trial. Lancet. 2016 Sep 17;388(10050):1183-92. doi: 10.1016/S0140-6736(16)31339-3. Epub 2016 Aug 16.
PubMed 27542302Ramanan AV, Dick AD, Benton D, Compeyrot-Lacassagne S, Dawoud D, Hardwick B, Hickey H, Hughes D, Jones A, Woo P, Edelsten C, Beresford MW; SYCAMORE Trial Management Group. A randomised controlled trial of the clinical effectiveness, safety and cost-effectiveness of adalimumab in combination with methotrexate for the treatment of juvenile idiopathic arthritis associated uveitis (SYCAMORE Trial). Trials. 2014 Jan 9;15:14. doi: 10.1186/1745-6215-15-14.
PubMed 24405833Vazquez-Cobian LB, Flynn T, Lehman TJ. Adalimumab therapy for childhood uveitis. J Pediatr. 2006 Oct;149(4):572-5. doi: 10.1016/j.jpeds.2006.04.058.
PubMed 17011337Chang CY, Meyer RM, Reiff AO. Impact of medication withdrawal method on flare-free survival in patients with juvenile idiopathic arthritis on combination therapy. Arthritis Care Res (Hoboken). 2015 May;67(5):658-66. doi: 10.1002/acr.22477.
PubMed 25220674Baszis K, Garbutt J, Toib D, Mao J, King A, White A, French A. Clinical outcomes after withdrawal of anti-tumor necrosis factor alpha therapy in patients with juvenile idiopathic arthritis: a twelve-year experience. Arthritis Rheum. 2011 Oct;63(10):3163-8. doi: 10.1002/art.30502.
PubMed 21702011Shakoor A, Esterberg E, Acharya NR. Recurrence of uveitis after discontinuation of infliximab. Ocul Immunol Inflamm. 2014 Apr;22(2):96-101. doi: 10.3109/09273948.2013.812222. Epub 2013 Jul 22.
PubMed 23876234Acharya NR, Ebert CD, Kelly NK, Porco TC, Ramanan AV, Arnold BF; ADJUST Research Group. Discontinuing adalimumab in patients with controlled juvenile idiopathic arthritis-associated uveitis (ADJUST-Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial): study protocol for a randomised controlled trial. Trials. 2020 Oct 27;21(1):887. doi: 10.1186/s13063-020-04796-z.
PubMed 33109240Acharya 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 39863370Davis JL. Defining Retinal Vasculitis. Am J Ophthalmol. 2024 Nov;267:84-89. doi: 10.1016/j.ajo.2024.05.030. Epub 2024 Jun 24.
PubMed 38925285
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial
- ClinicalTrials.gov ID
- NCT03816397
- Acronym / sponsor ID
- ADJUST / 17-23987
- Keywords
- chronic anterior uveitis, adalimumab, JIA-associated uveitis, stopping
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Nisha AcharyaUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Children's Mercy Hospital Kansas City, National Eye Institute (NEI), Great Ormond Street Hospital for Children NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Sheffield Children's NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Royal Children's Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust, Vanderbilt University Medical Center, University of California, Davis, University of Texas at Austin, University of Miami, University Hospitals, Leicester, University of Utah, Colorado Retina Associates, Manchester University NHS Foundation Trust
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a stratified, block-randomized, double-masked, controlled trial to determine the feasibility of discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU).
Detailed description
Background: Juvenile idiopathic arthritis (JIA)-associated uveitis is a chronic pediatric ocular inflammatory condition that can result in visual impairment. Chronic anterior uveitis (CAU) does not have systemic manifestations of disease but presents similarly in the eye and can result in identical visual complications as JIA-associated uveitis. Adalimumab, a tumor necrosis factor (TNF) inhibitor, effectively controls joint and eye inflammation; however, its long-term use may increase the risk of adverse health outcomes and place an undue financial burden on the patient and healthcare system given its high cost. There is great interest for patients to stop adalimumab following remission due to these reasons but there is a lack of information on the ability to maintain control after discontinuing adalimumab.
Methods: The Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Trial (ADJUST) is a multi-center international trial that will randomize 118 participants aged 2 years and older with controlled JIA-associated uveitis or chronic anterior uveitis to either continue adalimumab or discontinue adalimumab and receive a placebo. The trial will compare the time to uveitis recurrence between the two groups over 12 months. All participants will receive the standard weight-based dose of adalimumab or placebo: 20 mg biweekly (if < 30 kg) or 40 mg biweekly (if ≥ 30 kg).
Impact: This is the first randomized controlled trial to assess the efficacy of discontinuing adalimumab after demonstrating control of JIA-associated uveitis for at least 12 months. The results of ADJUST will provide information on clinical outcomes to guide clinicians in their decision-making regarding discontinuation of adalimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue adalimumab | Active comparator | Biological: AdalimumabPatients randomized to this arm will continue adalimumab at their current weight-based dose administered subcutaneously every other week. |
| Stop adalimumab | Placebo comparator | Other: PlaceboPatients randomized to this arm will receive a volume-matched placebo administered subcutaneously every other week. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Intraocular surgery in the past 90 days or planned surgery in the next 12 months
- Severe cataract or opacity preventing view to the posterior pole in both eyes
- Chronic hypotony (<5 mmHg for ≥90 days) in either eye
- Treatment with oral corticosteroids or intraocular corticosteroid injection within the last 12 months
- Use of NSAID eye drops within the last 90 days
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 |
|---|---|---|
| AdalimumabAlso: HUMIRAAdalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody, a biologic, immunomodulatory drug. Adalimumab 20mg/0.8 mL and 40mg/0.8 mL is a clear, colorless solution provided in a pre-filled syringe for subcutaneous injection. The formulation is adalimumab, mannitol, polysorbate 80, and water for injection Each pre-filled syringe has a fixed 29-gauge thin wall and ½ inch needle with black protective cover and is intended for a single dose to a single patient. | Biological | Continue adalimumab |
| PlaceboThe placebo solution is a clear, colorless solution provided in a single-use, pre-filled syringe for subcutaneous injection. The volume-matched (0.8mL) placebo is designed to match the characteristics of the citrate-free adalimumab during injection. | Other | Stop adalimumab |
Primary outcome
Time to Treatment Failure
Time frame: From baseline until 48 weeks post-randomization
Treatment failure is defined by recurrence of ocular inflammation in at least one eye as follows: * 3+ anterior chamber (AC) for a single visit •>0.5+ anterior chamber (AC) cell for ≥28 days * 2-step increase in AC cell observed at two separate visits ≥7 days apart * 0.5+ vitreous haze, active retinal or choroidal inflammation, or macular edema observed at a single visit. Treatment failure can also be declared by recurrence of joint inflammation that is persistent and severe enough to necessitate unmasking to manage the arthritis recurrence. Time (days) from all participants is included in the analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27602665Jaffe GJ, Dick AD, Brezin AP, Nguyen QD, Thorne JE, Kestelyn P, Barisani-Asenbauer T, Franco P, Heiligenhaus A, Scales D, Chu DS, Camez A, Kwatra NV, Song AP, Kron M, Tari S, Suhler EB. Adalimumab in Patients with Active Noninfectious Uveitis. N Engl J Med. 2016 Sep 8;375(10):932-43. doi: 10.1056/NEJMoa1509852.
- Background: PubMed 27542302Nguyen QD, Merrill PT, Jaffe GJ, Dick AD, Kurup SK, Sheppard J, Schlaen A, Pavesio C, Cimino L, Van Calster J, Camez AA, Kwatra NV, Song AP, Kron M, Tari S, Brezin AP. Adalimumab for prevention of uveitic flare in patients with inactive non-infectious uveitis controlled by corticosteroids (VISUAL II): a multicentre, double-masked, randomised, placebo-controlled phase 3 trial. Lancet. 2016 Sep 17;388(10050):1183-92. doi: 10.1016/S0140-6736(16)31339-3. Epub 2016 Aug 16.
- Background: PubMed 24405833Ramanan AV, Dick AD, Benton D, Compeyrot-Lacassagne S, Dawoud D, Hardwick B, Hickey H, Hughes D, Jones A, Woo P, Edelsten C, Beresford MW; SYCAMORE Trial Management Group. A randomised controlled trial of the clinical effectiveness, safety and cost-effectiveness of adalimumab in combination with methotrexate for the treatment of juvenile idiopathic arthritis associated uveitis (SYCAMORE Trial). Trials. 2014 Jan 9;15:14. doi: 10.1186/1745-6215-15-14.
- Background: PubMed 17011337Vazquez-Cobian LB, Flynn T, Lehman TJ. Adalimumab therapy for childhood uveitis. J Pediatr. 2006 Oct;149(4):572-5. doi: 10.1016/j.jpeds.2006.04.058.
- Background: PubMed 25220674Chang CY, Meyer RM, Reiff AO. Impact of medication withdrawal method on flare-free survival in patients with juvenile idiopathic arthritis on combination therapy. Arthritis Care Res (Hoboken). 2015 May;67(5):658-66. doi: 10.1002/acr.22477.
- Background: PubMed 21702011Baszis K, Garbutt J, Toib D, Mao J, King A, White A, French A. Clinical outcomes after withdrawal of anti-tumor necrosis factor alpha therapy in patients with juvenile idiopathic arthritis: a twelve-year experience. Arthritis Rheum. 2011 Oct;63(10):3163-8. doi: 10.1002/art.30502.
- Background: PubMed 23876234Shakoor A, Esterberg E, Acharya NR. Recurrence of uveitis after discontinuation of infliximab. Ocul Immunol Inflamm. 2014 Apr;22(2):96-101. doi: 10.3109/09273948.2013.812222. Epub 2013 Jul 22.
- Background: PubMed 33109240Acharya NR, Ebert CD, Kelly NK, Porco TC, Ramanan AV, Arnold BF; ADJUST Research Group. Discontinuing adalimumab in patients with controlled juvenile idiopathic arthritis-associated uveitis (ADJUST-Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial): study protocol for a randomised controlled trial. Trials. 2020 Oct 27;21(1):887. doi: 10.1186/s13063-020-04796-z.
- Results publication: 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.
- Derived from this study: PubMed 38925285Davis JL. Defining Retinal Vasculitis. Am J Ophthalmol. 2024 Nov;267:84-89. doi: 10.1016/j.ajo.2024.05.030. Epub 2024 Jun 24.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nisha Acharya, MD MS principal investigator
Principal Investigator
21 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 in people with Uveitis and JIA, run by Nisha Acharya at 21 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 0 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: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, United Kingdom, Australia. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Treatment Failure (time frame: From baseline until 48 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 NCT03816397, which also lists 10 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 11 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.