Table 3

Examination/observation schedule

Time pointScreeningRemission induction periodRemission maintenance periodAt trial withdrawal
Within 1 weekAt 0 month
(day1)
At 1 monthAt 2 monthsAt 4 monthsAt 6 monthsAt 9, 12, 18 and 24 months
At confirmation of relapse
Informed consent
BVAS
VDI●*
SF-36●*
Blood/urine tests●†
ECG, X-ray
Bone density●‡
Pregnancy test Embedded Image
  • Blood/urine tests: blood cell count including B cell count, serum biochemical tests (total protein, albumin, electrolytes (Na, K, Cl), BUN, serum creatinine, CPK, total bilirubin, AST, ALT, ALP, LDH, γ-GTP, CRP, IgG, IgA, IgM, C3, C4, complement titre, T-Cho, LDL-C, HDL-C, TG, blood glucose, HbA1c, MPO-/PR3-ANCA).

  • General urine test (glucose, protein, occult blood, sediment, urinary creatinine).

  • *Only at 12, 18 and 24 months.

  • †Screening blood test items.

  • ‡Only at 12 and 24 months.

  • ALP, alkaline phosphatase; ALT, alanine transaminase; ANCA, anti-neutrophil cytoplasmic antibody; AST, aspartate transaminase; BUN, blood urea nitorogen; BVAS, Birmingham Vasculitis Activity Score; Cl, chlorine; CPK, creatine phosphokinase; CRP, C-reactive protein; GTP, glutamyl transpeptidase; HbA1c, haemoglobin A1c; K, potassium; HDL-C, high density lipoprotein cholesterol; LDH, lactate dehydrogenase; LDL-C, low density lipoprotein cholesterol; MPO, myeloperoxidase; Na, sodium; PR3, proteinase3; SF-36, Medical Outcomes Study 36-Item Short Form; T-Cho, total cholesterol; TG, triglycerides; VDI, Vasculitis Damage Index.