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Table 1 Study visits and assessments

From: A phase II trial protocol of Tocilizumab in anti-TNF refractory patients with JIA-associated uveitis (the APTITUDE trial)

Assessment (Procedure/ Activity

Screening

Baseline

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7

Weeks

 

0 (−7/+ 7 days)

4 (− 7/+ 7 days)

8 (− 7/+ 7 days

12 (− 7/+ 7 days)

16 − 7/+ 7 days)

20 (− 7/+ 7 days)

24 (− 7/+ 7 days)

36 (− 7/+ 7 days)

 

Screening

Baseline/

Registration

Study Visit

Study Visit

Assessment of endpoints

Study Visit

Study Visit

End of treatment

End of trial

Written and informed consent

X

        

Confirm consent

X

X

X

X

X

X

X

X

X

Assessment of eligibility criteria

X

X

       

Review of Medical/ Ophthalmic/ Surgical History

X

        

Review of concomitant medications

X

X

X

X

X

X

X

X

X

Pregnancy test

X

 

X

X

X

X

X

X

X

Purified protein derivative Tuberculin Skin Test/ Test latent Tuberculosis as locally performed

X

        

Urinalysis

X

X

X

X

X

X

X

X

X

Study intervention (Injection)

 

X

X

X

X

X

X

X

 

Compliance with study intervention

 

X

X

X

X

X

X

X

 

Physical Examination

 

X

X

X

X

X

X

X

X

Vital signs (heart and respiratory rate and blood pressure)

X

 

X

X

X

X

X

X

X

Height/ Weight

X

X

X

X

X

X

X

X

X

Dispense treatment diary

 

X

X

X

X

X

X

X

 

Child Health Questionnaire

 

X

X

X

X

X

X

X

X

Childhood Health Assessment Questionnaire

 

X

X

X

X

X

X

X

X

Haematological analysis

X

X*

X

X

X

X

X

X

X

Biochemical analysis

X

X*

X

X

X

X

X

X

X

Anti-nuclear antibodies, double stranded deoxyribonucleic acid and extractable nuclear antigens

 

X

     

X

 

Samples for Biobank

 

X

  

X

   

X

Vision Assessments#

X

X

X

X

X

X

X

X

X

Optical coherence tomography

X

 

X

X

X

X

X

X

X

Anterior Chamber cells and flare assessment#

X

X

X

X

X

X

X

X

X

Assessment of vitritis and vitreous haze

X

 

X

X

X

X

X

X

X

Cataract scoring

X

 

X

X

X

X

X

X

X

Goldman tonometry or tonopen

X

 

X

X

X

X

X

X

X

Standard American College of Rheumatology Pediatric Score Set Outcome Variables

 

X

X

X

X

X

X

X

X

Tanner Score

 

X

  

X

  

X

X

Assessments of Adverse and Serious Adverse Events

 

X

X

X

X

X

X

  
  1. * Biochemical and Haematological taken at screening can be used at baseline only if taken with 2 weeks of baseline visit
  2. # Tests do not need to be repeated if screening and baseline visit occurs on the same day
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BMC Rheumatology

ISSN: 2520-1026

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