Adalimumab in JIA-associated Uveitis Stopping Trial

Part of paid clinical trials in Sacramento, California.

Sponsor
Nisha Acharya
Study ID
NCT03816397
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — BIOLOGICAL
    Adalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody, a biologic, immunomodulatory drug. Adalimumab 20mg/0.8 mL and 40mg/0.8 mL is a clear, colorless solution provided in a pre-filled syringe for subcutaneous injection. The formulation is adalimumab, mannitol, polysorbate 80, and water for injection Each pre-filled syringe has a fixed 29-gauge thin wall and ½ inch needle with black protective cover and is intended for a single dose to a single patient.
  • Placebo — OTHER
    The placebo solution is a clear, colorless solution provided in a single-use, pre-filled syringe for subcutaneous injection. The volume-matched (0.8mL) placebo is designed to match the characteristics of the citrate-free adalimumab during injection.

Study Details

The proposed study is a stratified, block-randomized, double-masked, controlled trial to determine the feasibility of discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU).

Key Dates

Start date
Mar 15, 2020
Status verified
May 2025
Primary completion
Jan 23, 2025
Completion
Apr 3, 2025

Study Design

Enrollment
87 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Continue adalimumab
    Patients randomized to this arm will continue adalimumab at their current weight-based dose administered subcutaneously every other week.
  • Placebo Comparator: Stop adalimumab
    Patients randomized to this arm will receive a volume-matched placebo administered subcutaneously every other week.

Primary Outcome Measure

Time to Treatment Failure [ Time Frame: From baseline until 48 weeks post-randomization ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817-
University of California, San FranciscoSan FranciscoCalifornia94143-
University of Colorado DenverAuroraColorado80045-
Colorado Retina AssociatesLakewoodColorado80228-
University of MiamiMiamiFlorida33136-
Children's Mercy HospitalKansas CityMissouri64108-
Cincinnati Children's HospitalCincinnatiOhio45229-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Vanderbilt University Medical CenterNashvilleTennessee37212-
University of Texas, AustinAustinTexas78712-
University of Utah HealthSalt Lake CityUtah84132-

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By research site
University of California, Davis· Sacramento, CAUniversity of California, San Francisco· San Francisco, CAUniversity of Colorado Denver· Aurora, COColorado Retina Associates· Lakewood, COUniversity of Miami· Miami, FLChildren's Mercy Hospital· Kansas City, MO

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