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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03816397




Registration number
NCT03816397
Ethics application status
Date submitted
22/01/2019
Date registered
25/01/2019

Titles & IDs
Public title
Adalimumab in JIA-associated Uveitis Stopping Trial
Scientific title
Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial
Secondary ID [1] 0 0
UG1EY029658
Secondary ID [2] 0 0
17-23987
Universal Trial Number (UTN)
Trial acronym
ADJUST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uveitis 0 0
JIA 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Adalimumab
Other interventions - Placebo

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.


Treatment: Other: 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 interventions: 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.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to treatment failure
Timepoint [1] 0 0
From baseline until 12 months post-randomization

Eligibility
Key inclusion 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 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)
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria (any one of these excludes the patient):

* Intraocular surgery in the past 90 days or planned surgery in the next 12 months
* 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
* Use of NSAID eye drops within the last 90 days
* 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)
* Presence of intraretinal or subretinal fluid in either eye
* 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 laboratory test results on their most recent tests within the past 90 days prior to screening/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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/07/2025
Actual
Sample size
Target
118
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Children's Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Bristol
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Cambridge
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Leicester
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Liverpool
Country [14] 0 0
United Kingdom
State/province [14] 0 0
London
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Manchester
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Newcastle Upon Tyne
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Norwich
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Other
Name
Nisha Acharya
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Children's Hospital of Philadelphia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Children's Hospital Medical Center, Cincinnati
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Children's Mercy Hospital Kansas City
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
National Eye Institute (NEI)
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Great Ormond Street Hospital for Children NHS Foundation Trust
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University Hospitals Bristol and Weston NHS Foundation Trust
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Alder Hey Children's NHS Foundation Trust
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Newcastle-upon-Tyne Hospitals NHS Trust
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Sheffield Children's NHS Foundation Trust
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Cambridge University Hospitals NHS Foundation Trust
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Royal Children's Hospital
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Norfolk and Norwich University Hospitals NHS Foundation Trust
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Vanderbilt University Medical Center
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
University of California, Davis
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
University of Texas at Austin
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
University of Miami
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
University Hospitals, Leicester
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
University of Utah
Address [18] 0 0
Country [18] 0 0
Other collaborator category [19] 0 0
Other
Name [19] 0 0
Colorado Retina Associates
Address [19] 0 0
Country [19] 0 0
Other collaborator category [20] 0 0
Government body
Name [20] 0 0
Manchester University NHS Foundation Trust
Address [20] 0 0
Country [20] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nisha Acharya, MD MS
Address 0 0
Principal Investigator
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03816397