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Table 1 Study visits and assessments a

From: 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)

  

Time (months)

 
  

Randomisation and commencement of treatment

       

End of treatment

     

End of trial

 

Events and assessments

Screeningb

0c

1

2

3

6

9

12

15

18

21

24

27

30

33

36

Premature withdrawal

Written informed consent

X

                

Confirmed consent (verbal)

 

X

X

X

X

X

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

X

X

X

X

X

X

X

X

Pregnancy test (serum)

 

(X)

  

X

X

X

X

X

X

X

      

Purified protein derivative tuberculin skin testd/test for latent TB as locally performed

X

                

Urinalysise

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Randomisation

 

X

               

Study intervention

 

X

X

X

X

X

X

X

X

X

       

Compliance with study intervention

 

X

X

X

X

X

X

X

X

X

       

Physical examination: complete

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Vital signs (heart and respiratory rates, temperature, blood pressure)

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Height

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Weight

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Childhood Health Questionnaire

 

X

X

X

X

X

X

X

X

X

       

Childhood Health Assessment Questionnaire

 

X

X

X

X

X

X

X

X

X

       

Health Utilities Index Mark 2 questionnaire

 

X

  

X

X

X

X

 

X

  

X

  

X

X

Client Service Receipt Inventory

 

X

               

Sample for DNA collection

(X)

   

(X)

    

(X)

       

RNA and serum/plasma

(X)

   

(X)

    

(X)

       

Haematological analysis

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Biochemical analysis

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Samples for HAHA analysesf

X

   

X

            

ANA, dsDNA and ENA

X

      

X

         

Ophthalmic assessments

                 

Vision assessment

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Optical coherence tomography (optional)

(X)

 

(X)

(X)

(X)

(X)

(X)

(X)

(X)

(X)

(X)

(X)

(X)

(X)

(X)

(X)

(X)

Assessment of vitritis

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Slit-lamp biomicroscopy

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Cataract scoring

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Goldmann tonometry or Tono-Pen

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Standard ACR paediatric core set outcome variables

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Tanner score

X

   

X

  

X

  

X

X

X

X

X

X

X

Review of participant diaries

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

(X)

Assessment of adverse events

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

  1. aACR, American College of Rheumatology; ANA, antinuclear antibody; dsDNA, double-stranded DNA; ENA, extractable nuclear antigen; HAHA, human antiadalimumab antibody to adalimumab; TB, tuberculosis; (X), as applicable/indicated/appropriate. bAll procedures should be done before study intervention. cVisit 0 must be completed and treatment must be commenced within 14 days of the screening visit (10 days for pregnancy test). dParticipants who are PPD-positive at screening will require a chest X-ray. Treatment of participants who have a positive PPD skin test and/or abnormal chest X-ray should be carried out in accordance with regional and/or national guidelines and initiated at least 4 weeks prior to the first dose of trial medication. Participants with recent (within 6 months of trial entry screen) positive PPD test (≥5 mm) who are being treated with appropriate prophylaxis may request a waiver for a PPD screening from the Medicines for Children Research Network Clinical Trials Unit. Documentation of the positive PPD test should be available, as well as chest X-ray reports, from the date of the positive PPD test and treatment or prophylaxis history from near the time of the participant’s conversion. eMicroscopic urinalysis will be obtained at baseline and for other visits only if relevant abnormalities greater than trace are noted on the dipstick analysis. fTo be done also as required if anaphylaxis occurs during trial.
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ISSN: 1745-6215