Documents | Adalimumab in Juvenile Idiopathic Arthritis-associated Stopping Trial (ADJUST)

Protocols and Manuals

Informed Consent Forms

US Sites:

Children's Hospital of Philadelphia (CHOP)

Children's Mercy Hospital (CMH) - Englis h and Spanish

Cincinnati Children's Hospital (CCH)

Colorado Retina Associates & University of Colorado Denver (CRA)

Johns Hopkins University (JHU)

Seattle Children’s Hospital (SEA)

University of California, San Francisco (UCSF)

University of Utah Health (UUH)

Study Forms

As a backup, paper-based study forms are available. Study data should be captured via the REDCap Mobile App. The ADJUST Coordinating Center will be providing a tablet for electronic data capture. All forms were updated on March 2023.

ADJUST Approval Letter

Eligibility and Screening Checklist

Baseline Demographics Form

Baseline Ophthalmology Form

Baseline Rheumatology Form

Visual Acuity Form

Clinical Eye Exam Form

OCT Form

Arthritis Evaluation Form

Standard of Care Lab Form

Research Sample Lab Form

Adverse Event Checklist

Medication Adherence Log

Treatment Assessment Forms

Baseline Treatment Assessment Form

Follow-up Treatment Assessment Form

Unmasked Treatment Assessment Form

Patient Dropout Form

Serious Adverse Event Narrative Form

Protocol Deviation Form

Interim Masking Decision Form

Child Health Assessment Questionnaire (CHAQ)

Children's Visual Function Questionnaire (CVFQ)

Effects of Youth's Eye disease Questionnaire (EYE-Q)

EYE-Q Parent Report

EYE-Q Youth Report

EuroQol 5 Dimensions Youth (EQ-5D-Y) Questionnaires

Australia - Patient Self-complete

Australia - Parent Proxy Complete

UK - Patient Self-complete

UK - Parent Proxy Complete

US - Patient Self-complete

US - Parent Proxy Complete

Reporting Materials

Administration Materials

Screening Log

Randomization Log

Drug Accountability Log - Pharmacy

Drug Accountability Log - Coordinator

ADJUST Training Log - v.1.0

Enrollment Facilitation Guide v1 .2

Baseline Visit Guide v1.3

Patient Scheduling Tool v3.0

Patient in ADJUST Provider Letter

Commercial Invoice Template (for anti-adalimumab antibody samples; for the US)

ProForma Commercial Invoice Template (for rectal samples; for the UK)

ProForma Commercial Invoice Template (for rectal samples; for Australia)

Patient Diaries

For patients on study medication only

Study medication only_template

For patients on study medication + AZA

Study medication + AZA_template

For patients on study medication + MMF

study medication + MMF_template

For patients on study medication + LEF

Study medication + LEF_template

For patients on study medication + MTX

Study medication + MTX_template

Certification Materials

Resources for Site Investigators

Investigator Brochure

Other Materials

Annual Research Group Meeting Presentation - May 11, 2021

Annual Research Group Meeting Presentation - May 18, 2021

ADJUST Explainer Video

ADJUST DSMC Letter (February 26 2024)

ADJUST Results Letter for Participants