Adalimumab in JIA-associated Uveitis Stopping Trial

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria (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) Exclusion Criteria (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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03816397
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nisha Acharya
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nisha Acharya, MD MS
Principal Investigator Affiliation Principal Investigator
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOtherNIHOtherOtherOtherOtherOtherOtherOtherOtherOtherOther
Overall Status Recruiting
Countries Australia, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Uveitis, JIA
Arms & Interventions

Arms

Active Comparator: Continue adalimumab

Patients randomized to this arm will continue adalimumab at their current dose (either 20mg/0.2mL or 40mg/0.4mL) administered subcutaneously every other week.

Placebo Comparator: Stop adalimumab

Patients randomized to this arm will receive a volume-matched placebo (0.8mL) administered subcutaneously every other week.

Interventions

Biological: - Adalimumab

Adalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody, a biologic, immunomodulatory drug. Adalimumab 20mg/0.8mL and 40mg/0.8mL 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.

Other: - Placebo

The placebo solution is a clear, colorless solution provided in a single-use, pre-filled syringe for subcutaneous injection. The placebo is designed to match the characteristics of the citrate-free adalimumab during injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94143

Site Contact

Nisha Acharya, MD MS

[email protected]

415-476-8131

The Johns Hopkins University, Baltimore, Maryland

Status

Not yet recruiting

Address

The Johns Hopkins University

Baltimore, Maryland, 21218

Site Contact

Jennifer Thorne, MD PhD

[email protected]

415-476-8131

Children's Mercy Hospital, Kansas City, Missouri

Status

Recruiting

Address

Children's Mercy Hospital

Kansas City, Missouri, 64108

Site Contact

Erin Stahl, MD

[email protected]

415-476-8131

Cincinnati Children's Hospital, Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229

Site Contact

Virginia Miraldi Utz, MD

[email protected]

415-476-8131

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

Stefanie Davidson, MD

[email protected]

415-476-8131

University of Utah Health, Salt Lake City, Utah

Status

Not yet recruiting

Address

University of Utah Health

Salt Lake City, Utah, 84132

Site Contact

Albert Vitale, MD

[email protected]

415-476-8131

Seattle Children's Hospital, Seattle, Washington

Status

Not yet recruiting

Address

Seattle Children's Hospital

Seattle, Washington, 98105

Site Contact

Michelle Cabrera, MD

[email protected]

415-476-8131

International Sites

The Royal Children's Hospital Melbourne, Parkville, Australia

Status

Not yet recruiting

Address

The Royal Children's Hospital Melbourne

Parkville, , 3052

Site Contact

Robyn Troutbeck

[email protected]

415-476-8131

University Hospitals Bristol, Bristol, United Kingdom

Status

Not yet recruiting

Address

University Hospitals Bristol

Bristol, , BS1 3NU

Site Contact

A V Ramanan

[email protected]

415-476-8131

Cambridge University Hospital, Cambridge, United Kingdom

Status

Not yet recruiting

Address

Cambridge University Hospital

Cambridge, ,

Alder Hey Children's Hospital, Liverpool, United Kingdom

Status

Not yet recruiting

Address

Alder Hey Children's Hospital

Liverpool, , L14 5AB

Site Contact

Jose Gonzalez-Martin

[email protected]

415-476-8131

Great Ormond Street Hospital, London, United Kingdom

Status

Not yet recruiting

Address

Great Ormond Street Hospital

London, , WC1N 3JH

Site Contact

Ameenat Solebo

[email protected]

415-476-8131

Great North Children's Hospital, Newcastle Upon Tyne, United Kingdom

Status

Not yet recruiting

Address

Great North Children's Hospital

Newcastle Upon Tyne, , NE1 4LP

Site Contact

Michael Clarke

[email protected]

415-476-8131

Norfolk and Norwich University Hospital, Norwich, United Kingdom

Status

Not yet recruiting

Address

Norfolk and Norwich University Hospital

Norwich, , NR4 6TZ

Sheffield Children's Hospital, Sheffield, United Kingdom

Status

Not yet recruiting

Address

Sheffield Children's Hospital

Sheffield, , S10 2TQ

Site Contact

Jessy Choi

[email protected]

415-476-8131

University Hospitals Southampton, Southampton, United Kingdom

Status

Not yet recruiting

Address

University Hospitals Southampton

Southampton, , SO16 6YD

Site Contact

Kristina May

[email protected]

415-476-8131