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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 formsScreening
visit
Randomizationa
Day 1 Stage 1/Day 1 of Stage 2 (direct entry)a
For Stage 1 failures with subsequent entry in Stage 2Month 1
visit
Month 3 visitMonth 6 visitgMonth 9 visitMonth 12 visitTreatment Stopping Visith
Informed consentX        
Eligibility reviewX        
DemographicsX        
Baseline medical historyX        
Labs: CBC,b chemistry panel, liver function tests, urinalysis, and other relevant laboratory testscX XXXXXXX
G6PD screening testX        
Urine pregnancy testdX        
Follow-up medical history  XXXXXXX
Baseline vasculitis medication formX        
Non-vasculitis medication formX XXXXXXX
Follow-up vasculitis medication form  XXXXXXX
Baseline comorbidity formX        
Follow-up comorbidity form     X XX
Drug diary and prednisone form XXXXXX  
Patient global assessmentX XXXXXXX
Physician global assessmentX XXXXXXX
PROMISX XXXXXXX
SF-36X XXXXXXX
SkindexX XXXXXXX
Standardized photographseX XXXXXXX
As necessaryf
 Adverse event report XXXXXXXX
 Diagnostic sinus & chest imaging formX        
 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