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Table 4 Data collection schedule for on-site visits (for the two study stages)

From: Protocol for a randomized multicenter study for isolated skin vasculitis (ARAMIS) comparing the efficacy of three drugs: azathioprine, colchicine, and dapsone

Data forms

Screening

visit

Randomizationa

Day 1 Stage 1/Day 1 of Stage 2 (direct entry)a

For Stage 1 failures with subsequent entry in Stage 2

Month 1

visit

Month 3 visit

Month 6 visitg

Month 9 visit

Month 12 visit

Treatment Stopping Visith

Informed consent

X

        

Eligibility review

X

        

Demographics

X

        

Baseline medical history

X

        

Labs: CBC,b chemistry panel, liver function tests, urinalysis, and other relevant laboratory testsc

X

 

X

X

X

X

X

X

X

G6PD screening test

X

        

Urine pregnancy testd

X

        

Follow-up medical history

  

X

X

X

X

X

X

X

Baseline vasculitis medication form

X

        

Non-vasculitis medication form

X

 

X

X

X

X

X

X

X

Follow-up vasculitis medication form

  

X

X

X

X

X

X

X

Baseline comorbidity form

X

        

Follow-up comorbidity form

     

X

 

X

X

Drug diary and prednisone form

 

X

X

X

X

X

X

  

Patient global assessment

X

 

X

X

X

X

X

X

X

Physician global assessment

X

 

X

X

X

X

X

X

X

PROMIS

X

 

X

X

X

X

X

X

X

SF-36

X

 

X

X

X

X

X

X

X

Skindex

X

 

X

X

X

X

X

X

X

Standardized photographse

X

 

X

X

X

X

X

X

X

As necessaryf

 Adverse event report

 

X

X

X

X

X

X

X

X

 Diagnostic sinus & chest imaging form

X

        

 Protocol deviation

         

 Hospitalization

         

 Death record

         

 Primary outcome of study

     

X

   

 Study therapy discontinuation

         

 Protocol termination form

         
  1. Stage 1 lasts up to 12 months. Subjects who fail Stage 1 will be re-randomized and enter Stage 2. Stage 2 lasts up to 12 months and restarts the visit schedule to month 1, month 3, etc., as outlined above
  2. aRandomization can occur remotely, see section 4div. of the protocol for details. Visits for months 1, 3, 6, 9, 12 have a +/− 2-week window
  3. bCBC monitoring between days 7 and 15 after starting azathioprine, then again 7 to 15 days later, continue monitoring every 2 weeks for months 2 and 3 of treatment, then monthly or more frequently if dosage alterations or other therapy changes; CBC monitoring at minimum of every 2 weeks for first 3 months, per standard practice for those receiving dapsone; CBC monitoring at minimum of every 3 months for those receiving colchicine. CBC monitoring applies to both Stage 1 and Stage 2
  4. cResults of labs drawn within 1 month prior to screening can be utilized to determine eligibility
  5. dUrine pregnancy test is only for women of child-bearing potential
  6. eSee protocol section 4fi for additional information on photographs
  7. fIn case of a severe adverse event, protocol deviation, or event corresponding to a study failure, efforts will be made to see the patient in person at the investigator study site as soon as possible
  8. gPrimary study endpoint is at month 6 of each stage, but follow-up is planned until month 12 (secondary outcomes)
  9. hThe Treatment Stopping Visit should only be completed for subjects meeting the criteria listed in section 4h of the protocol