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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