Skip to main content

Table 1 Study visits and selected assessments

From: Clinical effectiveness and safety of baricitinib for the treatment of juvenile idiopathic arthritis-associated uveitis or chronic anterior antinuclear antibody-positive uveitis: study protocol for an open-label, adalimumab active-controlled phase 3 clinical trial (JUVE-BRIGHT)

 

Screening

Treatment period part A

Early termination

Posttreatment follow-up

Visit #

V1

V1a

V2a

Baseline

V3

V4

V5

V6

V7

V8

ETVb

V801c

Study week

  

W0

W4

W8

W12

W16

W20

W24

Any week

 

Study day (approximately)

−42 to −1

 

0

28

56

84

112

140

168

Any day

28 ± 5 days after last dose

Visit window (days)

   

±4

  

Informed consent and assent

X

          

Demographics

X

          

Physical examinationd

X

          

Symptom-directed physical examinationd

  

X

X

X

X

X

X

X

X

X

Height

  

X

  

X

  

X

X

 

Weight

  

X

X

X

X

X

X

X

X

X

Occipital frontal circumference measurement in children up to 3 years of age

  

X

Xe

X

X

Vital signs (blood pressure, pulse, temperature)

  

X

X

X

X

X

X

X

X

X

JIA diagnosis (ILAR criteria)

X

          

Previous JIA and uveitis therapy

X

          

Visual acuity (LogMAR)

  

X

X

X

X

X

X

X

X

X

Slit-lamp examination of the retina and optic disc

  

X

X

X

X

X

X

X

X

X

Optical coherence tomography

  

X

X

X

X

X

X

X

X

X

Slit-lamp examination for anterior chamber cells and flare assessment

X

 

X

X

X

X

X

X

X

X

X

Slit-lamp examination for assessment of vitritis and vitreous haze

X

 

X

X

X

X

X

X

X

X

X

Cataract scoringf

  

X

X

X

X

X

X

X

X

X

IOP using I-Care tonometry, Goldmann tonometry, or Tono-Pen

  

X

X

X

X

X

X

X

X

X

Concomitant medications

X

 

X

X

X

X

X

X

X

X

X

Joint assessment

X

 

X

X

X

X

X

X

X

X

X

Physician’s Global Assessment of Disease Activity

X

 

X

X

X

X

X

X

X

X

X

Patient Uveitis-related Disease Activityg

X

 

X

X

X

X

X

X

X

X

X

Patient Uveitis-related Improvementg

     

X

  

X

X

X

Patient Arthritis Disease Activityg

X

 

X

X

X

X

X

X

X

X

X

Patient Arthritis Improvementg

     

X

  

X

X

X

Ophthalmologist Uveitis-related Disease Activity

X

 

X

X

X

X

X

X

X

X

X

Ophthalmologist Uveitis-related Improvement

     

X

  

X

X

X

CHAQh

  

X

X

X

X

X

X

X

X

X

CHQ-PF50h

  

X

  

X

  

X

X

X

Morning stiffness durationg

  

X

X

X

X

X

X

X

X

X

SPARCC Enthesitis Indexi

  

X

X

X

X

X

X

X

X

X

Clinical sacroiliitisi

  

X

X

X

X

X

X

X

X

X

Back mobility (Schober’s test)i

  

X

X

X

X

X

X

X

X

X

PASIj

  

X

X

X

X

X

X

X

X

X

hsCRP

X

 

X

X

X

X

X

X

X

X

X

ESRk

  

X

X

X

X

X

X

X

X

X

HLA-B27

    

X

      

RF and ACPA

X

          

Antinuclear antibodies

  

X

     

X

X

 

Clinical chemistryl

X

 

X

X

X

X

X

X

X

X

X

Hematology

X

 

X

X

X

X

X

X

X

X

X

Urinalysis

X

 

X

  

X

  

X

X

X

Iron studies (iron, TIBC, and ferritin)

  

X

  

X

  

X

X

X

Fasting lipid panel

  

X

  

X

  

X

X

X

IgA, IgG, IgM

  

X

  

X

  

X

X

X

  1. aBaseline laboratory samples should be taken before administration of the investigational product
  2. bETV occurs if the patient terminates participation early. If the ETV occurs on the same day as the scheduled visit, any assessments/procedures conducted during the scheduled visit should not be repeated for a separate ETV
  3. cPatients who complete the study or discontinue early from the study will have a posttreatment safety follow-up visit (V801) approximately 28 days after the last dose of investigational product
  4. dOne physical examination will be performed at visit 1. All subsequent physical examinations may be symptom-directed
  5. eOccipital frontal circumference measurement is required every 3 months for patients under 3 years of age, but is no longer required once the patient reaches 3 years of age
  6. fFor patients with cataracts at baseline, or who develop cataracts during the study
  7. gPatient-reported and caregiver-reported questionnaires will be administered on paper at the site and are recommended to be completed prior to any clinical examinations
  8. hCaregiver-reported questionnaires will be administered via an on-site electronic Clinical Outcome Assessment device and are recommended to be completed prior to any clinical assessments
  9. iFor patients with enthesitis-related juvenile idiopathic arthritis or JPsA
  10. jFor patients with JPsA
  11. kPerformed locally. To be drawn prior to dosing early in the visit
  12. lClinical chemistry will include eGFR
  13. ACPA, anti-citrullinated protein antibodies; CHAQ, Childhood Health Assessment Questionnaire; CHQ-PF50, Child Health Questionnaire-Parent Form 50; eGFR, estimated glomerular filtration rate; ESR, erythrocyte sedimentation rate; ETV, early termination visit; HLA-B27, human leukocyte antigen-B27; hsCRP, high-sensitivity C-reactive protein; Ig, immunoglobulin; ILAR, International League of Associations for Rheumatology; IOP, intraocular pressure; JIA, juvenile idiopathic arthritis; JPsA, juvenile psoriatic arthritis; LogMAR, logarithm of the minimum angle of resolution; PASI, Psoriasis Area and Severity Index; RF, rheumatoid factor; SPARCC, Spondyloarthritis Research Consortium of Canada; TIBC, total iron-binding capacity; V, visit; W, week
Back to article page

Trials

ISSN: 1745-6215