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 (NCT01138657) enrolled 239 people in total — 120 received a placebo (an inactive dummy injection) and 119 received adalimumab, a medicine given by injection. The trial was looking at a condition called non-infectious uveitis, which is inflammation inside the eye. The main thing the trial measured was how long it took before a participant's eye condition got noticeably worse — an event the trial called "treatment failure" — starting from week 6 of the study. Several additional things were also measured, including changes in the amount of inflammation inside the eye, changes in vision sharpness, and changes in the thickness of the central part of the retina (the light-sensitive layer at the back of the eye). The reported data shows that, for the main group of participants (those recruited outside Japan), the median time — meaning the point at which half the participants in each group had experienced a treatment failure — was 3.0 months in the placebo group and 5.6 months in the adalimumab group. For the combined group that included Japanese participants as well, the figures were 3.0 months and 4.8 months respectively. For the secondary measures, the reported data shows that changes in eye inflammation scores (graded on standardised scales) and vision sharpness scores were numerically smaller in the adalimumab group than in the placebo group at the end of the study. The median time before signs of fluid build-up at the back of the eye (macular oedema) appeared was reported as 6.2 months (placebo) versus 11.1 months (adalimumab) in the main study group. The reported percentage increase in central retinal thickness was also numerically lower in the adalimumab group than in the placebo group across both study populations. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 27602665) ↗
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 3 Uveitis Trial, Completed
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 18 years of age or older.
- You have been diagnosed with a non-infectious type of eye inflammation (uveitis) affecting the middle, back, or entire area of the eye.
- Your eye inflammation is still active despite taking oral steroid pills (prednisone or equivalent, between 10–60 mg/day) for at least 2 weeks, shown by specific signs in at least one eye (confirm with trial site).
- You have been on the same dose of oral steroid pills (prednisone or equivalent, 10–60 mg/day) for at least 2 weeks before the screening visit and continue on the same dose until your baseline visit.
- You have previously responded well to oral steroid treatment at higher doses.
- You have tested negative for tuberculosis (TB) using either a skin test or a blood test, with no history of previous, active, or latent TB.
Who may not be able to join:
- You only have inflammation at the front of the eye (anterior uveitis only).
- You did not respond adequately to high-dose steroid treatment in the past.
- You have or are suspected to have eye inflammation caused by an infection (such as TB, herpes, toxoplasmosis, Lyme disease, or others).
- You have a specific eye condition called serpiginous choroidopathy.
- You have cloudiness in your cornea or lens that blocks a clear view of the back of your eye, or you are likely to need cataract surgery during the trial.
- You have high eye pressure (25 mmHg or above) and are already using two or more glaucoma medications, or you have signs of glaucoma damage to your optic nerve.
- Your best corrected vision is very poor (below a certain level) in at least one eye at the baseline visit (confirm with trial site).
- You have a type of uveitis with specific signs (such as "snowbanking" or "snowballs") along with symptoms or brain scan findings suggesting a nerve-related disease like multiple sclerosis — and if applicable, you have not had a brain MRI within the past 90 days.
- You have previously been treated with anti-TNF therapy or any other biologic medication (except certain eye injections) that could affect uveitis.
- You are taking one additional immune-suppressing medication and the dose was increased in the last 28 days, or the dose is higher than the specific amounts allowed in the trial (confirm with trial site).
- You have had a long-term steroid implant in your eye (Retisert®) within the past 3 years, or it was removed within the past 90 days, or you had complications related to it.
- You have received steroid injections in or around your eye within the past 30 days.
- You have advanced diabetic eye disease or significant diabetic-related swelling at the centre of your vision.
- You have the "wet" form of age-related macular degeneration.
- You have a structural eye problem at the back of the eye that could cause damage to your central vision independently of the inflammation (confirm with trial site).
- The cloudiness in the gel inside your eye is so severe that the back of the eye cannot be seen clearly at the baseline visit.
- You have received a dexamethasone eye implant (Ozurdex®) within the past 6 months.
- You have received certain anti-VEGF eye injections (Lucentis®, Avastin®, or Eylea®/aflibercept) within the past 45–60 days, depending on the medication.
- You have received methotrexate injected into your eye within the past 90 days.
- You have taken a type of medication called a carbonic anhydrase inhibitor by mouth within 1 week before the screening visit.
- Swelling at the centre of your vision (macular edema) is the only sign of your eye inflammation.
- You have a history of inflammation of the white outer coat of the eye (scleritis).
- You cannot tolerate high doses of oral steroids (confirm with trial site).
- You have taken cyclophosphamide (a strong immune-suppressing drug) within the past 30 days.
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.
GP referral letter
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Trial details
Primary endpoints
Time to Treatment Failure on or After Week 6
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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.