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NCT03828019 · ClinicalTrials.gov registry record · Phase 3
Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
A Phase 3 study, sponsored by JHSPH Center for Clinical Trials.
- Completed
- Registry status
- Phase 3
- Development phase
- 227
- Enrollment target
NCT03828019: Completed Phase 3 study, sponsored by JHSPH Center for Clinical Trials.
NCT03828019 is a Phase 3 study that has completed, run by JHSPH Center for Clinical Trials. The registered enrollment target is 227 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03828019, a Phase 3 study, has completed, sponsored by JHSPH Center for Clinical Trials.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 227 participants
- Enrollment target
Study Summary
Non-infectious intermediate, posterior, and panuveitides are chronic, potentially-blinding diseases. Vision-threatening cases require long-term therapy with oral corticosteroids and immunosuppression. Based upon preliminary data, adalimumab, a fully-human, anti-tumor necrosis(TNF)-α monoclonal antibody, now US FDA-approved for uveitis treatment, may be a superior corticosteroid-sparing agent than conventional immunosuppressive drugs. The ADVISE Trial is multicenter randomized, parallel-treatment, comparative effectiveness trial comparing adalimumab to conventional (small molecule) immunosuppression for corticosteroid spring in the treatment of non-infectious, intermediate, posterior, and panuveitides.
Primary Outcome
Corticosteroid-sparing success is defined as achieving inactive uveitis for two consecutive visits \>= 28 days apart while on \<= 7.5 mg/day of corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging. Steroid dose and uveitis activity from visit months 6,8,10 and 12 were included in the analysis. Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of cort
Interventions
- BIOLOGICAL Adalimumab (ADA)
- DRUG Conventional immunosuppression (CON)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2024-09-09 |
| Phase | Phase 3 |
What the finished NCT03828019 record still lists
NCT03828019 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Adalimumab (ADA) is the first listed.
NCT03828019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03828019 about?
NCT03828019 is a clinical study titled "Adalimumab vs. Conventional Immunosuppression for Uveitis Trial". Non-infectious intermediate, posterior, and panuveitides are chronic, potentially-blinding diseases. Vision-threatening cases require long-term therapy with oral corticosteroids and immunosuppression. Based upon preliminary data, adalimumab, a fully-human, anti-tumor necrosis(TNF)-α monoclonal antib...
What is the current status of trial NCT03828019?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 227 participants. The study started on 2019-09-16. Estimated completion is 2024-09-09.
What interventions are being tested in trial NCT03828019?
The interventions under investigation include: Adalimumab (ADA) (BIOLOGICAL), Conventional immunosuppression (CON) (DRUG).
Who is sponsoring clinical trial NCT03828019?
This trial is sponsored by JHSPH Center for Clinical Trials, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03828019's enrollment target sits among peer trials
227 1310th of 2000 higher than 691 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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