A Phase 4 interventional study of Adalimumab and Placebo in Uveitis and JIA, sponsored by Nisha Acharya. Completed at 21 sites in 3 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Nisha Acharya · Phase 4, Interventional, and Treatment
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).
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.
335 studies on the registry are indexed under Uveitis; 37 are open to participants now.
This study's enrollment of 87 is above the median of 30 across 208 interventional studies indexed under Uveitis.
Browse Uveitis studies →Nisha Acharya is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (must meet all of the following to qualify):
Exclusion Criteria (any one of these excludes the patient):
There are no sex, race, or ethnicity restrictions for this study.
Patients randomized to this arm will continue adalimumab at their current weight-based dose administered subcutaneously every other week.
Biological: Adalimumab
Patients randomized to this arm will receive a volume-matched placebo administered subcutaneously every other week.
Other: Placebo
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.
Also known as: HUMIRA
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.
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.
Time frame: From baseline until 48 weeks post-randomization
Patients were enrolled from March 3, 2020, to Feb 14, 2024, at 20 ophthalmology and rheumatology clinical sites across the United States, the United Kingdom, and Australia.
| Milestone | Continue Adalimumab | Stop Adalimumab |
|---|---|---|
| Started | 43 | 44 |
| Completed | 29 | 37 |
| Not completed | 14 | 7 |
| Withdrew: Censored at interim analysis date. | 13 | 6 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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.
| Time to treatment failure (days) | Continue Adalimumab | Stop Adalimumab |
|---|---|---|
| Time to Treatment Failure | NA (NA to NA) | 119 (84 to 243) |
Collected over Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continue Adalimumab | 0/43 (0%) | 4/43 (9.3%) | 34/43 (79.1%) |
| Stop Adalimumab | 0/44 (0%) | 0/44 (0%) | 29/44 (65.9%) |
| Event | Continue Adalimumab | Stop Adalimumab |
|---|---|---|
| Surgery for torted cyst of MorgagniSurgical and medical procedures | 1/43 | 0/44 |
| Shortness of breath at rest; suspected to be anxiety-relatedPsychiatric disorders | 1/43 | 0/44 |
| Over 5 times the upper limit of normal for alanine aminotransferaseBlood and lymphatic system disorders | 1/43 | 0/44 |
| Planned orthognathic surgerySurgical and medical procedures | 1/43 | 0/44 |
| Event | Continue Adalimumab | Stop Adalimumab |
|---|---|---|
| Gastrointestinal relatedGastrointestinal disorders | 24/43 | 17/44 |
| HeadacheGeneral disorders | 17/43 | 10/44 |
| FatigueGeneral disorders | 15/43 | 8/44 |
| Other eventsGeneral disorders | 14/43 | 9/44 |
| COVID-19Infections and infestations | 12/43 | 1/44 |
| Upper respiratory infectionInfections and infestations | 9/43 | 7/44 |
| FeverInfections and infestations | 8/43 | 2/44 |
| Mood changesPsychiatric disorders | 6/43 | 3/44 |
| Allergic reactionRespiratory, thoracic and mediastinal disorders | 5/43 | 1/44 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 4/43 | 3/44 |
| Age, Continuous(years) | Continue Adalimumab | Stop Adalimumab | Total |
|---|---|---|---|
| Median | 12.56 (9.44 to 15.81) | 12.26 (9.39 to 13.42) | 12.31 (9.39 to 15.28) |
| Sex: Female, Male(Participants) | Continue Adalimumab | Stop Adalimumab | Total |
|---|---|---|---|
| Female | 32 | 32 | 64 |
| Male | 11 | 12 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Continue Adalimumab | Stop Adalimumab | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 8 | 14 |
| Not Hispanic or Latino | 35 | 28 | 63 |
| Unknown or Not Reported | 2 | 8 | 10 |
| Race (NIH/OMB)(Participants) | Continue Adalimumab | Stop Adalimumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 34 | 33 | 67 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 1 | 4 | 5 |
| Region of Enrollment(participants) | Continue Adalimumab | Stop Adalimumab | Total |
|---|---|---|---|
| United States | 14 | 14 | 28 |
| United Kingdom | 27 | 27 | 54 |
| Australia | 2 | 3 | 5 |
| Conventional DMARD Use(Participants) | Continue Adalimumab | Stop Adalimumab | Total |
|---|---|---|---|
| Azathioprine | 1 | 3 | 4 |
| Leflunomide | 2 | 1 | 3 |
| Methotrexate (oral) | 13 | 9 | 22 |
| Methotrexate (subcutaneous) | 14 | 15 | 29 |
| Mycophenolate mofetil | 1 | 3 | 4 |
| None | 12 | 13 | 25 |
| Arthritis category(Participants) | Continue Adalimumab | Stop Adalimumab | Total |
|---|---|---|---|
| None; chronic anterior uveitis | 7 | 7 | 14 |
| Oligoarthritis | 29 | 29 | 58 |
| Polyarthritis | 7 | 6 | 13 |
| Psoriatic arthritis | 0 | 1 | 1 |
| Undifferentiated arthritis | 0 | 1 | 1 |
| Age at diagnosis of juvenile idiopathic arthritis, years(years) | Continue Adalimumab | Stop Adalimumab | Total |
|---|---|---|---|
| Median | 2.77 (2.30 to 4.52) | 3.71 (2.36 to 6.18) | 3.30 (2.32 to 5.59) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nisha Acharya