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Adalimumab in JIA-associated Uveitis Stopping Trial (ADJUST)

Primary Purpose

Uveitis, JIA

Status

Recruiting

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Adalimumab

Placebo

About this trial

This is an interventional treatment trial for Uveitis focused on measuring chronic anterior uveitis, adalimumab, JIA-associated uveitis, stopping

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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)
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Continue adalimumab

Stop adalimumab

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Time to treatment failure

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 a single visit. 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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03816397

First Posted

January 22, 2019

Last Updated

August 21, 2023

Sponsor

Nisha Acharya

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 and Weston NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Sheffield Children's NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Royal Children's Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust, Vanderbilt University Medical Center, University of California, Davis, University of Texas at Austin, University of Miami, University Hospitals, Leicester, University of Utah, Colorado Retina Associates, Manchester University NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT03816397

Brief Title

Adalimumab in JIA-associated Uveitis Stopping Trial

Acronym

ADJUST

Official Title

Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2020 (Actual)

Primary Completion Date

April 30, 2025 (Anticipated)

Study Completion Date

July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nisha Acharya

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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) or chronic anterior uveitis (CAU).

Detailed Description

Background: Juvenile idiopathic arthritis (JIA)-associated uveitis is a chronic pediatric ocular inflammatory condition that can result in visual impairment. Chronic anterior uveitis (CAU) does not have systemic manifestations of disease but presents similarly in the eye and can result in identical visual complications as JIA-associated uveitis. Adalimumab, a tumor 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 multi-center international trial that will randomize 118 participants aged 2 years and older with controlled JIA-associated uveitis or chronic anterior 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 randomized 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uveitis, JIA

Keywords

chronic anterior uveitis, adalimumab, JIA-associated uveitis, stopping

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Continue adalimumab

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Stop adalimumab

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

HUMIRA

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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 Measure Information:

Title

Time to treatment failure

Description

Time Frame

From baseline until 12 months post-randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility 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) 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nisha Acharya, MD MS

Phone

415-476-8131

nisha.acharya@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nisha Acharya, MD MS

Organizational Affiliation

Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Davis

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Parisa Emami-Naeini, MD, MPH

First Name & Middle Initial & Last Name & Degree

Parisa Emami-Naeini, MD, MPH

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nisha Acharya, MD MS

First Name & Middle Initial & Last Name & Degree

Nisha Acharya, MD MS

First Name & Middle Initial & Last Name & Degree

John Gonzales, MD

First Name & Middle Initial & Last Name & Degree

Thuy Doan, MD PhD

Facility Name

University of Colorado Denver

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katharine Moore, MD

First Name & Middle Initial & Last Name & Degree

Katharine Moore, MD

Facility Name

Colorado Retina Associates

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80228

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mark Dacey, MD

First Name & Middle Initial & Last Name & Degree

Mark Dacey, MD

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Janet L Davis, MD

First Name & Middle Initial & Last Name & Degree

Janet L Davis, MD

Facility Name

Children's Mercy Hospital

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erin Stahl, MD

First Name & Middle Initial & Last Name & Degree

Erin Stahl, MD

First Name & Middle Initial & Last Name & Degree

Ashley Cooper, MD

Facility Name

Cincinnati Children's Hospital

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Virginia Miraldi Utz, MD

First Name & Middle Initial & Last Name & Degree

Adam Kaufman, MD

First Name & Middle Initial & Last Name & Degree

Sheila Angeles-Han, MD

First Name & Middle Initial & Last Name & Degree

Virginia Miraldi Utz, MD

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefanie Davidson, MD

First Name & Middle Initial & Last Name & Degree

Stefanie Davidson, MD

First Name & Middle Initial & Last Name & Degree

Melissa Lerman, MD PhD

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sapna Gangaputra, MD, MPH

First Name & Middle Initial & Last Name & Degree

Sapna Gangaputra, MD, MPH

Facility Name

University of Texas, Austin

City

Austin

State/Province

Texas

ZIP/Postal Code

78712

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric Crowell, MD, MPH

First Name & Middle Initial & Last Name & Degree

Eric Crowell, MD, MPH

Facility Name

University of Utah Health

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Albert Vitale, MD

First Name & Middle Initial & Last Name & Degree

Albert Vitale, MD

First Name & Middle Initial & Last Name & Degree

Aimee Hersh, MD

Facility Name

Murdoch Children's Research Institute

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

William Renton

Phone

+61 03 9345 5522

william.renton@rch.org.au

First Name & Middle Initial & Last Name & Degree

Robyn Troutbeck

Phone

+61 04 1160 4664

rtroutbeck@gmail.com

First Name & Middle Initial & Last Name & Degree

Robyn Troutbeck

First Name & Middle Initial & Last Name & Degree

William Renton

Facility Name

University Hospitals Bristol and Weston

City

Bristol

ZIP/Postal Code

BS1 3NU

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

A V Ramanan

First Name & Middle Initial & Last Name & Degree

A V Ramanan

First Name & Middle Initial & Last Name & Degree

Andrew Dick

Facility Name

Cambridge University Hospital

City

Cambridge

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kate Armon

First Name & Middle Initial & Last Name & Degree

Brinda Muthusamy

Facility Name

University Hospitals, Leicester

City

Leicester

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arani Sridhar, MD

Facility Name

Alder Hey Children's Hospital

City

Liverpool

ZIP/Postal Code

L14 5AB

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose Gonzalez-Martin

First Name & Middle Initial & Last Name & Degree

Jose Gonzalez-Martin

First Name & Middle Initial & Last Name & Degree

Gavin Clearly

First Name & Middle Initial & Last Name & Degree

Michael Beresford

Facility Name

Great Ormond Street Hospital

City

London

ZIP/Postal Code

WC1N 3JH

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elena Moraitis

First Name & Middle Initial & Last Name & Degree

Elena Moraitis

First Name & Middle Initial & Last Name & Degree

Harry Petrushkin

Facility Name

Manchester University NHS Foundation Trust

City

Manchester

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jane Ashworth, MD

First Name & Middle Initial & Last Name & Degree

Jane Ashworth, MD

Facility Name

Great North Children's Hospital

City

Newcastle Upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Clarke

First Name & Middle Initial & Last Name & Degree

Michael Clarke

First Name & Middle Initial & Last Name & Degree

Sharmila Jandial

Facility Name

Norfolk and Norwich University Hospital

City

Norwich

ZIP/Postal Code

NR4 6TZ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Narman Puvanachandra

First Name & Middle Initial & Last Name & Degree

Louise

First Name & Middle Initial & Last Name & Degree

Kate Armon

First Name & Middle Initial & Last Name & Degree

Narman Puvanachandra

Facility Name

Sheffield Children's Hospital

City

Sheffield

ZIP/Postal Code

S10 2TQ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessy Choi

First Name & Middle Initial & Last Name & Degree

Jessy Choi

First Name & Middle Initial & Last Name & Degree

Daniel Hawley

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27602665

Citation

Jaffe GJ, Dick AD, Brezin AP, Nguyen QD, Thorne JE, Kestelyn P, Barisani-Asenbauer T, Franco P, Heiligenhaus A, Scales D, Chu DS, Camez A, Kwatra NV, Song AP, Kron M, Tari S, Suhler EB. Adalimumab in Patients with Active Noninfectious Uveitis. N Engl J Med. 2016 Sep 8;375(10):932-43. doi: 10.1056/NEJMoa1509852.

Results Reference

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PubMed Identifier

27542302

Citation

Nguyen QD, Merrill PT, Jaffe GJ, Dick AD, Kurup SK, Sheppard J, Schlaen A, Pavesio C, Cimino L, Van Calster J, Camez AA, Kwatra NV, Song AP, Kron M, Tari S, Brezin AP. Adalimumab for prevention of uveitic flare in patients with inactive non-infectious uveitis controlled by corticosteroids (VISUAL II): a multicentre, double-masked, randomised, placebo-controlled phase 3 trial. Lancet. 2016 Sep 17;388(10050):1183-92. doi: 10.1016/S0140-6736(16)31339-3. Epub 2016 Aug 16. Erratum In: Lancet. 2016 Sep 17;388(10050):1160.

Results Reference

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PubMed Identifier

24405833

Citation

Ramanan AV, Dick AD, Benton D, Compeyrot-Lacassagne S, Dawoud D, Hardwick B, Hickey H, Hughes D, Jones A, Woo P, Edelsten C, Beresford MW; SYCAMORE Trial Management Group. A randomised controlled trial of the clinical effectiveness, safety and cost-effectiveness of adalimumab in combination with methotrexate for the treatment of juvenile idiopathic arthritis associated uveitis (SYCAMORE Trial). Trials. 2014 Jan 9;15:14. doi: 10.1186/1745-6215-15-14.

Results Reference

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PubMed Identifier

17011337

Citation

Vazquez-Cobian LB, Flynn T, Lehman TJ. Adalimumab therapy for childhood uveitis. J Pediatr. 2006 Oct;149(4):572-5. doi: 10.1016/j.jpeds.2006.04.058.

Results Reference

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PubMed Identifier

25220674

Citation

Chang CY, Meyer RM, Reiff AO. Impact of medication withdrawal method on flare-free survival in patients with juvenile idiopathic arthritis on combination therapy. Arthritis Care Res (Hoboken). 2015 May;67(5):658-66. doi: 10.1002/acr.22477.

Results Reference

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PubMed Identifier

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Citation

Baszis K, Garbutt J, Toib D, Mao J, King A, White A, French A. Clinical outcomes after withdrawal of anti-tumor necrosis factor alpha therapy in patients with juvenile idiopathic arthritis: a twelve-year experience. Arthritis Rheum. 2011 Oct;63(10):3163-8. doi: 10.1002/art.30502.

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Citation

Shakoor A, Esterberg E, Acharya NR. Recurrence of uveitis after discontinuation of infliximab. Ocul Immunol Inflamm. 2014 Apr;22(2):96-101. doi: 10.3109/09273948.2013.812222. Epub 2013 Jul 22.

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Citation

Acharya NR, Ebert CD, Kelly NK, Porco TC, Ramanan AV, Arnold BF; ADJUST Research Group. Discontinuing adalimumab in patients with controlled juvenile idiopathic arthritis-associated uveitis (ADJUST-Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial): study protocol for a randomised controlled trial. Trials. 2020 Oct 27;21(1):887. doi: 10.1186/s13063-020-04796-z.

Results Reference

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Learn more about this trial

Adalimumab in JIA-associated Uveitis Stopping Trial

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Adalimumab in JIA-associated Uveitis Stopping Trial (ADJUST)

Uveitis, JIA

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial