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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Adalimumab/Biosimilar
Biological/VaccineAdalimumab 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).
Treatment groups
160 Participants
are divided into 4 treatment groupsGroup A: 2-Week DoseActive comparator 1 intervention
Group B: 4-Week DoseExperimental treatment 1 intervention
Group C: 8-Week DoseExperimental treatment 1 intervention
Group D: 12-Week DoseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative Incidence of Treatment Failure
Proportion of participants in each treatment arm experiencing treatment failure by Week 24. Treatment failure is defined by recurrence of ocular inflammation (at least one of the following in at least one eye): * \>0.5+ anterior chamber (AC) cell at a single visit as defined by the Standardization of Uveitis Nomenclature (SUN) criteria * \>0.5+ vitreous haze at a single visit * Active retinal/choroidal inflammation and/or macular edema in either eye at a single visit. Macular edema is defined as central subfield thickness on optical coherence tomography (OCT) \>2 standard deviations above normal thickness (\>320µm on Spectralis or \>300µm on Zeiss or Topcon) and having a greater than 20% increase from baseline and/or presence of intraretinal or subretinal fluid. Treatment failure may also be defined as recurrence of joint disease persistent and severe enough to necessitate unmasking to manage the arthritis recurrence.
Time frame
From baseline to 24 weeks post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
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