Treatment for Uveitis

3
Effectiveness
3
Safety
Children's Hospital of Philadelphia, Philadelphia, PA
Uveitis+1 More
Eligibility
Any Age
All Sexes
Eligible conditions
Uveitis

Study Summary

This study is evaluating whether a medication used to treat arthritis may help reduce inflammation in the eyes of children with arthritis.

See full description

Eligible Conditions

  • Uveitis
  • JIA

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome in patients with Uveitis. Measurement will happen over the course of From baseline until 12 months post-randomization.

Month 12
Time to treatment failure

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Continue adalimumab
Placebo group

This trial requires 118 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Continue adalimumab
Biological
Patients randomized to this arm will continue adalimumab at their current dose (either 20mg/0.2mL or 40mg/0.4mL) administered subcutaneously every other week.
Stop adalimumab
Other
Patients randomized to this arm will receive a volume-matched placebo (0.8mL) administered subcutaneously every other week.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline until 12 months post-randomization
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from baseline until 12 months post-randomization for reporting.

Closest Location

Children's Hospital of Philadelphia - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are willing to comply with all study procedures and are available for the duration of the study period. show original
≥ 2 years of age
History of JIA or CAU diagnosed prior to 16 years of age (patient may be older than 16 at time of enrollment)
You have a formal diagnosis of JIA-associated uveitis or CAU with no other suspected etiology. show original
≥12 consecutive months of controlled ocular inflammation (≤0.5+ anterior chamber cell, ≤0.5+ vitreous haze, no active retinal/choroidal lesions in either eye, no macular edema)
You have had arthritis for at least 12 consecutive months. show original
You have been treated with adalimumab or a biosimilar of adalimumab for at least 12 consecutive months. show original
≥180 days on a stable dose of adalimumab or a biosimilar; must be biweekly dose of either 20mg (if<30kg) or 40mg (if ≥30kg)
You have been on adalimumab for ≥90 days on the biosimilar. show original
You are on methotrexate and your dose is ≤25mg weekly and stable for ≥90 days. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for uveitis?

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The current results are based on our best experience. The efficacy and tolerability, as determined by the number and type of patient reports, is generally very good. Immunosuppressive medicines, such as MMF, a subgroup of which is also used for treatment of GVHD, may decrease the prevalence of uveitis compared to other drugs. Some newer immunosuppressants, such as MMFX, may cause an increased prevalence of lymphocytic choriomeningitis (LCM). MMFX treatment should thus usually be withheld during the time frame for LCM.

Unverified Answer

What is uveitis?

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Uveitis refers to a group of pathological conditions of the eyes. The presentation of uveitis varies and should be evaluated with special attention because, in a varying percentage, uveitis is the most common manifestation of an autoimmune disease. All sorts of ophthalmological problems can be attributed to uveitis, from simple and trivial to serious to life-threatening. The management of uveitis is, therefore, a complicated process, requiring the consultation of many professionals with the aim of ensuring a successful outcome. Most of the ophthalmologists of Switzerland treat patients with uveitis under referral of internists or rheumatologists.

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How many people get uveitis a year in the United States?

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The annual number of new diagnoses of uveitis appears to be on the rise, and the number of patients with uveitis may also be increasing. To the best of our knowledge, this is the first such report to describe the actual numbers of patients with uveitis annually in the United States.

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What causes uveitis?

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In a large number of cases uveitis is caused by a systemic disease. Uveitis in patients with normal immune function appears to be caused in a number of cases by an immune disorder affecting one of the components of the retino-tracheal-bronchial-cerebro-spinal-fludrocortisone axis.

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What are the signs of uveitis?

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To treat uveitis one will need to find the reason for it. It can be tricky as there is no single cause for it, they are all intertwined and it’s possible that multiple factors are involved. The signs of uveitis can help pinpoint what is happening in the eyes. When a doctor and person are talking about what needs to be done, you should keep these in mind. They change and can take on many forms when it comes to uveitis. The most used signs can be redness, itchiness, blurred vision, and a white or yellowish (sometimes brown) fluid in the eye.

Unverified Answer

What are the latest developments in treatment for therapeutic use?

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We believe that the future application of biologic therapy and synthetic compounds may yield an improvement in the management of refractory uveitis of both active and inactive nature.

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What is treatment?

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Treatment for uveitis is generally based on the clinical picture and varies from one physician to another. In cases where uveitis is misdiagnosed, the disease can be fatal.

Unverified Answer

What is the primary cause of uveitis?

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From our study, we concluded that the primary cause of uveitis is not the HLA-B27, but possibly a certain type of eye drops. However, we could not ascertain the cause of uveitis in all cases. It is only a clue. In addition, the cause may be different in cases of posterior uveitis and anterior uveitis. We will be conducting a clinical study focusing on new medicines which can treat uveitis.

Unverified Answer

Have there been other clinical trials involving treatment?

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Patients are at low risk for serious harm when receiving therapies in a clinical trial when these interventions seem to benefit patients. A more realistic perspective is that if our therapies do not work, it's because they don't work yet. It is possible that we could learn much more about treating uveitis if we study patients during their actual, everyday conditions that are very different from the laboratory settings used in most clinical trials. If we use treatments with which patients have long-term problems such as glaucoma or diabetic sight loss, we are unlikely to expect the results to be different from what they would be in those settings.

Unverified Answer

What does treatment usually treat?

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Uveitis treatment aims to stop inflammation and alleviate its pain and sight-threatening effects, as the eye may swell and become painful to close. The symptoms of uveitis depend on where the swelling occurs and what causes it. Eye-drops may contain steroids to reduce inflammation. Other drugs are usually prescribed to slow down or stop the production of proteins and fluids in the eye that produce inflammation. Doctors use a variety of approaches to treat and control inflammation or inflammation-inducing conditions. Examples of disease or conditions a person may have to deal with, and their treatment include multiple sclerosis, rheumatoid arthritis, multiple sclerosis-related spondylarthritis, thyroid disorders, cancer, psoriasis, eczema, and sepsis.

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Does uveitis run in families?

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We found no evidence for a genetic etiology in non-specific, bilateral or familial nephritis in the first-degree relatives. Neither isolated nor familial uveitis was found. Based upon these findings, we hypothesize that non-specific uveitis is probably more heterogeneously triggered and is not transmitted through genes.

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