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 |