Adalimumab for Pediatric Uveitis

(ADAPT Trial)

Not yet recruiting at 17 trial locations
NA
Overseen ByNisha Acharya, MD MS
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: Nisha Acharya
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn whether children and young adults with well-controlled juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior uveitis can safely take adalimumab (or biosimilar) injections less often while maintaining control of their disease.

The main question it aims to answer is: can adalimumab/biosimilar injections be given less frequently without uveitis (eye inflammation) or arthritis (joint inflammation) returning?

Researchers will compare adalimumab/biosimilar injection schedules of every 2 weeks, 4 weeks, 8 weeks, and 12 weeks to determine how injection frequency affects disease control.

Participants will:

* Take adalimumab/biosimilar injections every 2, 4, 8, or 12 weeks.

* Attend study visits every 6 weeks over 24 weeks, with an additional follow-up visit at 48 weeks for checkups, tests, and questionnaires.

* Keep a diary of how often they take adalimumab/biosimilar and other drugs they take for their uveitis/arthritis.

Who Is on the Research Team?

NA

Nisha Acharya, MD MS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for children and young adults with well-controlled juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior uveitis. Participants should already be taking adalimumab or a similar medication to manage their eye inflammation.

Inclusion Criteria

I have been on a stable dose of adalimumab or its biosimilar for at least 180 days.
I have uveitis caused by JIA or chronic anterior uveitis with no other known cause.
Weight must be ≥15kg
See 13 more

Exclusion Criteria

I have used NSAID eye drops in the past 90 days.
I have had or will have eye surgery within the specified time frames.
I have had episodes of eye redness, pain, floaters, or light sensitivity from uveitis.
See 10 more

What Are the Treatments Tested in This Trial?

Interventions

  • Adalimumab/Biosimilar

Trial Overview

The study tests if people with controlled uveitis can safely take adalimumab (or its biosimilar) injections less often—every 2, 4, 8, or 12 weeks—without the disease coming back. Different injection schedules are compared over about one year.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: 8-Week DoseExperimental Treatment1 Intervention
Group II: 4-Week DoseExperimental Treatment1 Intervention
Group III: 12-Week DoseExperimental Treatment1 Intervention
Group IV: 2-Week DoseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nisha Acharya

Lead Sponsor

Trials
1
Recruited
90+

National Eye Institute (NEI)

Collaborator

Trials
572
Recruited
1,320,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

University of California, Davis

Collaborator

Trials
958
Recruited
4,816,000+

University of California, Los Angeles

Collaborator

Trials
1,594
Recruited
10,430,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials
844
Recruited
6,566,000+

Children's Mercy Hospital Kansas City

Collaborator

Trials
261
Recruited
941,000+

University of Miami

Collaborator

Trials
976
Recruited
423,000+

University of Utah

Collaborator

Trials
1,169
Recruited
1,623,000+