Monoclonal Antibodies

Adalimumab (ADA) for Uveitis

Emory University, Atlanta, GA
Conventional immunosuppression (CON) +1 morePhase 3RecruitingResearch Sponsored by JHSPH Center for Clinical Trials

Study Summary

This trial is testing whether a new drug, adalimumab, is better than existing treatments for a chronic, potentially blinding disease.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have had or currently have inflammation in the middle or back part of your eye that is not caused by an infection, and it has been less than 60 days since it was active.
If you have eye inflammation at the back of your eye, you must be able to have at least one eye examined to evaluate its activity.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Corticosteroid-sparing treatment success within the first 6 months after randomization
Secondary outcome measures
Best corrected visual acuity
Corticosteroid-sparing treatment success within the first 12 months after randomization
Generic health-related quality of life
+7 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.

Trial Design

2Treatment groups
Active Control
Group I: Adalimumab (ADA)Active Control1 Intervention
Adalimumab administered by subcutaneous injection at dosage and frequency specified below; total duration of treatment is 12 months. Adults (≥ 18 years of age) and adolescents ≥30 kg: 80 mg as initial dose; one week later by 40 mg then 40 mg every two weeks. Adolescents <30 kg: 40 mg as initial dose; one week later 20 mg then 20 mg every 2 weeks.
Group II: Conventional immunosuppression (CON)Active Control1 Intervention
Conventional immunosuppressive agent selected by study ophthalmologist at dose and frequency specified below;12 month treatment duration. Azathioprine: initially 2 mg/kg/day; max dose 200 mg/day. Methotrexate initially 15mg/wk; max dose 25 mg/wk. Mycophenolate initially 1 gm BID; max dose1.5 gm BID. Cyclosporine (Sandimmune - dose 2.5 mg/kg BID and Neoral dose 2 mg/kg BID. Tacrolimus initially 1 mg BID; max dose 3 mg BID.

Find a site

Who is running the clinical trial?

JHSPH Center for Clinical TrialsLead Sponsor
10 Previous Clinical Trials
3,165 Total Patients Enrolled
3 Trials studying Uveitis
641 Patients Enrolled for Uveitis
Douglas A Jabs, MD MBAStudy Chair
CCTand Evidence Synthesis, JHU, Bloomberg School of Public Health

Media Library

Adalimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03828019 — Phase 3
Uveitis Research Study Groups: Adalimumab (ADA), Conventional immunosuppression (CON)
Uveitis Clinical Trial 2023: Adalimumab Highlights & Side Effects. Trial Name: NCT03828019 — Phase 3
Adalimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03828019 — Phase 3
Uveitis Patient Testimony for trial: Trial Name: NCT03828019 — Phase 3

Frequently Asked Questions

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

Are there any unfilled slots in this clinical trial?

"The listed clinical trial on is searching for participants. The posting dates for this study were September 17th, 2019 and June 16th, 2022 respectively."

Answered by AI

What do we know about CON from other previous clinical trials?

"At the moment, 513 clinical studies are underway which focus on Conventional immunosuppression (CON). Out of these CON trials, 112 have progressed to Phase 3. Most investigations into Conventional immunosuppression (CON) originate from Philadelphia, but there are 11,025 research centres spread out across the globe looking into this topic."

Answered by AI

Where are the trial sites for this experiment?

"University of California, San Francisco in San Francisco, California, Tennessee Retina in Nashville, Tennessee, and University of Iowa in Iowa City, Iowa are a few example locations where this trial is taking place. In total, there are 21 sites running this study."

Answered by AI

What is the mortality rate associated with CON treatment?

"There is some efficacy data and multiple rounds of safety data available for Conventional immunosuppression (CON), so it received a score of 3."

Answered by AI

What is the standard treatment that Conventional immunosuppression (CON) is used for?

"Ocular rosacea is most often treated with immunosuppressive drugs, which are also sometimes used to manage transplant patients, those with small cell lung cancer, and people suffering from dermatitis or atopic conditions."

Answered by AI

How many people are involved in the research project?

"The website has the latest information on this study, which is currently looking for 222 participants at 21 sites. The trial was first posted on September 17th, 2019 and was last updated on June 16th, 2020."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What site did they apply to?
University of California, San Francisco
Retinal Consultants of Texas
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I have recurring uveitis and scared about going blind.

What questions have other patients asked about this trial?

- is this a paid trial?
~44 spots leftby Sep 2024