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Adalimumab in JIA-associated Uveitis Stopping Trial (ADJUST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03816397
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : March 24, 2020
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
Children's Mercy Hospital Kansas City
National Eye Institute (NEI)
Great Ormond Street Hospital for Children NHS Foundation Trust
University Hospitals Bristol NHS Foundation Trust
Alder Hey Children's NHS Foundation Trust
Johns Hopkins University
Children's Hospital Los Angeles
Seattle Children's Hospital
Newcastle-upon-Tyne Hospitals NHS Trust
University Hospital Southampton NHS Foundation Trust
Sheffield Children's NHS Foundation Trust
The Royal Children's Hospital
Information provided by (Responsible Party):
Nisha Acharya, University of California, San Francisco

Brief 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).

Condition or disease Intervention/treatment Phase
Uveitis JIA Biological: Adalimumab Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Adalimumab

Arm Intervention/treatment
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.
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 Name: HUMIRA

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




Primary Outcome Measures :
  1. Time to treatment failure [ Time Frame: From baseline until 12 months post-randomization ]

    Time to treatment failure until 12 months post-randomization. Treatment failure is defined by recurrence of ocular inflammation in at least one eye as follows:

    • 3+ anterior chamber (AC) for a single visit

      •>0.5+ anterior chamber (AC) cell for ≥28 days

    • 2-step increase in AC cell observed at two separate visits ≥7 days apart

      • 0.5+ vitreous haze, active retinal or choroidal inflammation, or macular edema observed at two separate visits ≥7 days apart. Treatment failure can also be declared by recurrence of joint inflammation that is persistent and severe enough to necessitate unmasking to manage the arthritis recurrence.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816397


Contacts
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Contact: Nisha Acharya, MD MS 415-476-8131 nisha.acharya@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Nisha Acharya, MD MS         
Principal Investigator: Nisha Acharya, MD MS         
Principal Investigator: John Gonzales, MD         
Principal Investigator: Thuy Doan, MD PhD         
United States, Maryland
The Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21218
Contact: Jennifer Thorne, MD PhD         
Principal Investigator: Jennifer Thorne, MD PhD         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Erin Stahl, MD         
Principal Investigator: Erin Stahl, MD         
Principal Investigator: Ashley Cooper, MD         
United States, Ohio
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Virginia Miraldi Utz, MD         
Principal Investigator: Adam Kaufman, MD         
Principal Investigator: Shelia Angeles-Han, MD         
Principal Investigator: Virginia Miraldi Utz, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Stefanie Davidson, MD         
Principal Investigator: Stefanie Davidson, MD         
Principal Investigator: Melissa Lerman, MD PhD         
United States, Utah
University of Utah Health Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Albert Vitale, MD         
Principal Investigator: Albert Vitale, MD         
Principal Investigator: Aimee Hersh, MD         
United States, Washington
Seattle Children's Hospital Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Michelle Cabrera, MD         
Principal Investigator: Michelle Cabrera, MD         
Principal Investigator: Erin Herlihy, MD         
Principal Investigator: Kabita Nanda, MD         
Australia
The Royal Children's Hospital Melbourne Not yet recruiting
Parkville, Australia, 3052
Contact: Robyn Troutbeck         
Principal Investigator: Robyn Troutbeck         
Principal Investigator: Lyndell Lim         
Principal Investigator: Jane Munro         
United Kingdom
University Hospitals Bristol Not yet recruiting
Bristol, United Kingdom, BS1 3NU
Contact: A V Ramanan         
Principal Investigator: A V Ramanan         
Principal Investigator: Andrew Dick         
Cambridge University Hospital Not yet recruiting
Cambridge, United Kingdom
Principal Investigator: Kate Armon         
Principal Investigator: Brinda Muthusamy         
Alder Hey Children's Hospital Not yet recruiting
Liverpool, United Kingdom, L14 5AB
Contact: Jose Gonzalez-Martin         
Principal Investigator: Jose Gonzalez-Martin         
Principal Investigator: Gavin Clearly         
Principal Investigator: Michael Beresford         
Great Ormond Street Hospital Not yet recruiting
London, United Kingdom, WC1N 3JH
Contact: Ameenat Solebo         
Principal Investigator: Ameenat Solebo         
Principal Investigator: Clive Edelsten         
Principal Investigator: Sandrine Lacassagne         
Principal Investigator: Lucy Wedderburn         
Great North Children's Hospital Not yet recruiting
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Contact: Michael Clarke         
Principal Investigator: Michael Clarke         
Principal Investigator: Sharmila Jandial         
Norfolk and Norwich University Hospital Not yet recruiting
Norwich, United Kingdom, NR4 6TZ
Principal Investigator: Kate Armon         
Principal Investigator: Narman Puvanachandra         
Sheffield Children's Hospital Not yet recruiting
Sheffield, United Kingdom, S10 2TQ
Contact: Jessy Choi         
Principal Investigator: Jessy Choi         
Principal Investigator: Daniel Hawley         
University Hospitals Southampton Not yet recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Kristina May         
Principal Investigator: Kristina May         
Principal Investigator: Alice Leahy         
Sponsors and Collaborators
Nisha Acharya
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
Children's Mercy Hospital Kansas City
National Eye Institute (NEI)
Great Ormond Street Hospital for Children NHS Foundation Trust
University Hospitals Bristol NHS Foundation Trust
Alder Hey Children's NHS Foundation Trust
Johns Hopkins University
Children's Hospital Los Angeles
Seattle Children's Hospital
Newcastle-upon-Tyne Hospitals NHS Trust
University Hospital Southampton NHS Foundation Trust
Sheffield Children's NHS Foundation Trust
The Royal Children's Hospital
Investigators
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Principal Investigator: Nisha Acharya, MD MS Principal Investigator
Publications:

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Responsible Party: Nisha Acharya, Director, Uveitis and Ocular Inflammatory Disease Service, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03816397    
Other Study ID Numbers: 17-23987
UG1EY029658 ( U.S. NIH Grant/Contract )
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents