Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial

Who is this study for? Patients with juvenile idiopathic arthritis-associated uveitis
What treatments are being studied? Adalimumab
Status: Completed
Location: See all (21) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 4
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) or chronic anterior uveitis (CAU).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

• Stated willingness to comply with all study procedures and availability for the duration of the study period

• ≥ 2 years of age

• History of JIA or CAU diagnosed prior to 16 years of age (patient may be older than 16 at time of enrollment)

• Formal diagnosis of JIA-associated uveitis or CAU with no other suspected etiology

• ≥12 consecutive months of controlled ocular inflammation (≤0.5+ anterior chamber cell, ≤0.5+ vitreous haze, no active retinal/choroidal lesions in either eye)

• ≥ 12 consecutive months of controlled arthritis verified by a pediatric rheumatologist, if defined as JIA-associated uveitis

• ≥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 antimetabolite (injectable or oral methotrexate, mycophenolate mofetil, azathioprine, or leflunomide), dose must be ≤25 mg weekly for methotrexate, ≤3 g daily for mycophenolate mofetil, ≤250 mg daily for azathioprine, or ≤20 mg daily for leflunomide; dose and route of administration must be 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)

• 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)

Locations
United States
California
University of California, Davis
Sacramento
University of California, San Francisco
San Francisco
Colorado
University of Colorado Denver
Aurora
Colorado Retina Associates
Lakewood
Florida
University of Miami
Miami
Missouri
Children's Mercy Hospital
Kansas City
Ohio
Cincinnati Children's Hospital
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
University of Texas, Austin
Austin
Utah
University of Utah Health
Salt Lake City
Other Locations
Australia
Murdoch Children's Research Institute
Parkville
United Kingdom
University Hospitals Bristol and Weston
Bristol
Cambridge University Hospital
Cambridge
University Hospitals, Leicester
Leicester
Alder Hey Children's Hospital
Liverpool
Great Ormond Street Hospital
London
Manchester University NHS Foundation Trust
Manchester
Great North Children's Hospital
Newcastle Upon Tyne
Norfolk and Norwich University Hospital
Norwich
Sheffield Children's Hospital
Sheffield
Time Frame
Start Date: 2020-03-15
Completion Date: 2025-04-03
Participants
Target number of participants: 87
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Colorado Retina Associates, Newcastle-upon-Tyne Hospitals NHS Trust, Vanderbilt University Medical Center, Norfolk and Norwich University Hospitals NHS Foundation Trust, University of Miami, Children's Hospital Medical Center, Cincinnati, Royal Children's Hospital, Alder Hey Children's NHS Foundation Trust, Children's Hospital of Philadelphia, University Hospitals Bristol and Weston NHS Foundation Trust, University of Texas at Austin, Children's Mercy Hospital Kansas City, Great Ormond Street Hospital for Children NHS Foundation Trust, Sheffield Children's NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust, University of Utah, University of California, Davis, National Eye Institute (NEI), University Hospitals, Leicester
Leads: Nisha Acharya

This content was sourced from clinicaltrials.gov

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