Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2+
SponsorNisha Acharya
About 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.
Eligibility criteria
Qualifiers
Stated willingness to comply with all study procedures and availability for the duration of the study period
History of juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU), diagnosed prior to 16 years of age (patient may be older than 16 at time of enrollment)
≥2 years of age (per FDA approval for use in children with polyarticular JIA)
Weight must be ≥15kg
Disqualifiers
History of acute anterior uveitis characterized by redness and symptoms, including but not limited to floaters, pain, and light sensitivity
Intraocular surgery in the past 90 days or planned surgery in the next 24 weeks
Severe cataract or opacity preventing view to the posterior pole in both eyes
Chronic hypotony (<5mmHg for ≥90 days) in either eye
Trial design
Treatments tested in this trial
- Adalimumab/Biosimilar
Treatment groups
160 Participants
are divided into 4 treatment groupsSponsors and collaborators
Nisha Acharya
Lead sponsor
University of California, San Francisco
Sponsor institution
National Eye Institute (NEI)
Collaborator
National Institutes of Health (NIH)
Collaborator
University of California, San Francisco
Collaborator
University of California, Davis
Collaborator
University of California, Los Angeles
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator
Children's Mercy Hospital Kansas City
Collaborator
University of Miami
Collaborator
University of Utah
Collaborator
University of Texas at Austin
Collaborator
Vanderbilt University Medical Center
Collaborator
University Hospitals Bristol and Weston NHS Foundation Trust
Collaborator
Alder Hey Children's NHS Foundation Trust
Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborator
Manchester University NHS Foundation Trust
Collaborator
Sheffield Children's NHS Foundation Trust
Collaborator
University Hospitals, Leicester
Collaborator
Meyer Children's Hospital IRCCS
Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborator
Moorfields Eye Hospital NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov