Phase 4 Uveitis Trial, Completed NCT03816397 Sponsor: Nisha Acharya Condition: Uveitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT03816397) involved 87 people with a condition involving eye inflammation (ocular inflammation) linked to joint disease. Participants were split into two groups: 43 people continued taking a medicine called adalimumab, and 44 people stopped taking it. The trial was measuring how long it took before signs of eye or joint inflammation came back — called "treatment failure" — after being assigned to one of these two approaches. The reported data shows that for the group who stopped adalimumab, the median time to treatment failure was 119 days (roughly four months). This means that, based on the data, half of the people in the "stop" group had a return of inflammation within about 119 days, and half took longer than that. For the group who continued taking adalimumab, the median time to treatment failure was reported as "NA" (not available or not reached), which typically means that during the study period, fewer than half of participants in that group experienced a return of inflammation — however, the specific reason this figure was not available is not explained in the reported data. It is also worth noting that more participants in the "continue" group did not complete the study (14 out of 43) compared to the "stop" group (7 out of 44), though the reasons for this are not detailed in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 4 Uveitis Trial, Completed

NCT03816397
Completed Phase 4 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing to follow all study rules and are available for the full length of the study
  • You are 2 years of age or older
  • You were diagnosed with juvenile idiopathic arthritis (a type of childhood arthritis) or chronic eye inflammation before age 16 (you can be older than 16 when joining the trial)
  • You have a confirmed diagnosis of eye inflammation linked to juvenile idiopathic arthritis or chronic eye inflammation with no other known cause
  • Your eye inflammation has been well controlled for at least 12 months in a row, based on specific eye exam measurements
  • If your eye inflammation is linked to juvenile idiopathic arthritis, your joint disease has also been well controlled for at least 12 months, as confirmed by a specialist children's doctor
  • You have been taking adalimumab (or a very similar approved medicine) for at least 12 months in a row
  • You have been on a stable, every-two-weeks dose of adalimumab (or similar medicine) for at least 180 days
  • If you are taking the similar version of adalimumab (a biosimilar), you have been on it for at least 90 days
  • If you are also taking certain other medicines to control your immune system (such as methotrexate or similar drugs), your dose is within specific limits and has been stable for at least 90 days (confirm with trial site)
  • If you are using steroid eye drops, you are using no more than 2 drops per day of a standard strength and the dose has been stable for at least 90 days
  • You are willing to limit alcohol during the study
  • You agree not to receive any live vaccines during the study
  • If you are able to have children, you agree to use highly effective birth control for at least 28 days before the study starts and throughout the study
  • The trial doctor considers it appropriate for you to continue on adalimumab or a dummy medicine (placebo)
  • You have no medical reasons that would prevent you from taking adalimumab

Who may not be able to join:

  • You have had eye surgery in the last 90 days or have eye surgery planned in the next 12 months
  • You have a severe clouding of the lens or other blockage in both eyes that prevents a clear view of the back of the eye
  • You have had persistently very low eye pressure (below a safe level) in either eye for 90 days or more
  • You have taken steroid tablets by mouth or had a steroid injection into the eye in the last 12 months
  • You have used anti-inflammatory eye drops (NSAID type) in the last 90 days
  • You currently have a sudden, active flare of eye inflammation with symptoms such as redness, floaters, pain, or sensitivity to light
  • You are pregnant or breastfeeding (pregnancy tests will be done at the start and throughout the study for anyone who could become pregnant)
  • There is fluid build-up in certain layers at the back of either eye
  • You have previously had serious safety or tolerability problems with adalimumab
  • You have a history of cancer, active tuberculosis (a type of serious infection), or hepatitis B (a liver infection)
  • You have another medical condition that is expected to affect which treatments you can receive during the study
  • Your most recent blood test results (taken within the last 90 days) show certain abnormal levels in your blood counts or liver/kidney function (confirm with trial site)

There are no restrictions based on sex, race, or ethnicity for this study.


Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Nisha Acharya, MD MS, Principal Investigator

Australian sites

Murdoch Children's Research Institute, Parkville, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 4
Sponsor
Nisha Acharya
Registry
ClinicalTrials.gov
Start date
15 March 2020
Est. completion
23 January 2025

Where this trial is recruiting

🇦🇺 Australia 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Time to Treatment Failure

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov