Summary

Eligibility
for people ages 2 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Nisha Acharya, MD MS (ucsf)John Gonzales, MD (ucsf)Thuy Doan, MD PhD (ucsf)
Photo of Nisha Acharya
Nisha Acharya
Photo of John Gonzales
John Gonzales
Photo of Thuy Doan
Thuy Doan

Description

Summary

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).

Official Title

Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial

Details

Background: Juvenile idiopathic arthritis (JIA)-associated uveitis is a chronic paediatric ocular inflammatory condition that can result in visual impairment. Adalimumab, a tumour necrosis factor (TNF)-alpha inhibitor, effectively controls joint and eye inflammation; however, its long-term use may increase the risk of adverse health outcomes and place an undue financial burden on the patient and healthcare system given its high cost. There is great interest for patients to stop adalimumab following remission due to these reasons but there is a lack of information on the ability to maintain control after discontinuing adalimumab. Methods: The Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Trial (ADJUST) is a multicentred, international trial that will randomise 118 participants aged 2 years and older with controlled JIA-associated uveitis to either continue adalimumab or discontinue adalimumab and receive a placebo. The trial will compare the time to uveitis recurrence between the two groups over 12 months. All participants will receive the standard weight-based dose of adalimumab or placebo: 20 mg biweekly (if < 30 kg) or 40 mg biweekly (if ≥ 30 kg). Impact: This is the first randomised controlled trial to assess the efficacy of discontinuing adalimumab after demonstrating control of JIA-associated uveitis for at least 12 months. The results of ADJUST will provide information on clinical outcomes to guide clinicians in their decision-making regarding discontinuation of adalimumab.

Keywords

Uveitis JIA Adalimumab Continue adalimumab Stop adalimumab

Eligibility

You can join if…

Open to people ages 2 years and up

(must meet all of the following to qualify):

  • Stated willingness to comply with all study procedures and availability for the duration of the study period
  • ≥ 2 years of age
  • History of JIA diagnosed prior to 16 years of age (patient may be older than 16 at time of enrollment)
  • ≥12 consecutive months of controlled ocular inflammation (≤0.5+ anterior chamber cell, ≤0.5+ vitreous haze, no active retinal/choroidal lesions in either eye, no macular edema)
  • ≥ 12 consecutive months of controlled arthritis verified by a pediatric rheumatologist
  • ≥12 consecutive months of treatment with adalimumab or a biosimilar of adalimumab
  • ≥180 days on a stable dose of adalimumab or a biosimilar; must be biweekly dose of either 20mg (if<30kg) or 40mg (if ≥30kg)
  • If on a biosimilar of adalimumab, ≥90 days on the biosimilar
  • If on concomitant methotrexate, dose must be ≤25mg weekly and stable for ≥90 days
  • If on concomitant mycophenolate mofetil, dose must be ≤3g daily and stable for ≥90 days
  • If on topical corticosteroids, dose must be ≤2 drops prednisolone acetate 1% or equivalent per day and stable for ≥90 days
  • Willingness to limit consumption of alcohol during the study period
  • Agreement to avoid live attenuated vaccinations
  • Agreement to use highly effective contraception for ≥28 days prior to screening and throughout study period (for males and females of reproductive age)
  • A negative tuberculosis (TB) test within the past 12 months or a positive test for TB with a history of completed treatment for latent TB
  • Suitable, in the opinion of the Investigator, to continue treatment with adalimumab or placebo per regional labeling
  • No contraindications to receive adalimumab as per the local Summary of Product Characteristics (SmPC)

You CAN'T join if...

(any one of these excludes the patient):

  • Intraocular surgery in the past 90 days or planned surgery in the next 180 days
  • Severe cataract or opacity preventing view to the posterior pole in both eyes
  • Chronic hypotony (<5mmHg for ≥90 days) in either eye
  • Treatment with oral corticosteroids or intraocular corticosteroid injection within the last 12 months
  • Current use of NSAID eye drops
  • Acute anterior uveitis characterized by redness and symptoms, including but not limited to floaters, pain, and light sensitivity
  • Pregnancy or lactation (a pregnancy test will be conducted at baseline and all follow-up visits for females of reproductive age)
  • Prior safety or tolerability issues with adalimumab
  • History of cancer, active tuberculosis, or hepatitis B
  • Other medical condition expected to dictate treatment course during the study
  • Any of the following abnormal lab values within 28 days prior to enrollment: leukocyte count <2500, platelet count ≤75000, hemoglobin<9.0, AST or ALT ≥ 2 times the upper limit of normal range, creatinine ≥1.5

There are no sex, race, or ethnicity restrictions for this study.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • University of Utah Health accepting new patients
    Salt Lake City Utah 84132 United States

Lead Scientists at University of California Health

  • Nisha Acharya, MD MS (ucsf)
    Nisha Acharya is the Director of the Uveitis and Ocular Inflammatory Disease Service and the Uveitis Fellowship at the F.I. Proctor Foundation. Her clinical expertise is the diagnosis and management of patients with infectious and inflammatory eye diseases. She is experienced with the latest treatments for uveitis, including treatment with new immunomodulatory drugs and biologic therapies.
  • John Gonzales, MD (ucsf)
    Associate Professor, Proctor Foundation. Authored (or co-authored) 65 research publications. Research interests: Uveitis · primary vitreoretinal lymphoma · herpetic eye disease · dry eye · Sjögren's syndrome.
  • Thuy Doan, MD PhD (ucsf)
    Associate Professor, Proctor Foundation. Authored (or co-authored) 67 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Nisha Acharya
ID
NCT03816397
Phase
Phase 4
Study Type
Interventional
Last Updated