Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial

Conditions

• Juvenile Idiopathic Arthritis Associated Uveitis
• Uveitis, Anterior

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Adalimumab/Biosimilar — BIOLOGICAL
  Adalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody - a biologic, immunomodulatory drug. Adalimumab (20mg or 40mg) is a clear, colorless solution available as an injectable auto-pen or pre-filled syringe for subcutaneous injection. All FDA-approved adalimumab biosimilars are allowed for this trial and include: Abrilada (adalimumab-afzb), Amjevita (adalimumab-atto), Cyltezo (adalimumab-adbm), Hadlima (adalimumab-bwwd), Hulio (adalimumab-fkjp), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Simlandi (adalimumab-ryvk), Yuflyma (adalimumab-aaty), and Yusimry (adalimumab-aqvh).

Study Details

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.

Key Dates

First listed

Jul 13, 2026

Start date

Sep 30, 2026

Status verified

Jul 2026

Primary completion

May 31, 2030

Completion

Nov 30, 2030

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 2-Week Dose
  Participants receive adalimumab/biosimilar at their current weight-based dose every 2 weeks for 24 weeks, continuing in accordance with current standard of care practice.
• Experimental: 4-Week Dose
  Participants receive adalimumab/biosimilar at their current weight-based dose every 4 weeks for 24 weeks.
• Experimental: 8-Week Dose
  Participants receive adalimumab/biosimilar at their current weight-based dose every 8 weeks for 24 weeks.
• Experimental: 12-Week Dose
  Participants receive adalimumab/biosimilar at their current weight-based dose every 12 weeks for 24 weeks.

Primary Outcome Measure

Cumulative Incidence of Treatment Failure [ Time Frame: From baseline to 24 weeks post-randomization ]

Central Contacts

• Nisha Acharya, MD MS
  415-476-8131
  [email protected]

Locations (9)

Find similar trials in Los Angeles, CA

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