CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors

Launched by HOSPICES CIVILS DE LYON · Nov 15, 2006

Keywords

ClinConnect Summary

All patients initially treated with systemic corticosteroids alone: optional IV methylprednisolone pulse (15 mg/kg) at treatment start followed by oral prednisone (1 mg/kg/day) according to a tapering schedule. Treating physicians allowed to treat minor relapses with corticosteroids without referring the patient for randomization, as long as the prednisone dose did not exceed 0.5 mg/kg for 1 month.

Patients in whom prednisone doses could not be tapered below 20 mg, those who failed to enter remission and those who relapsed were randomized to receive either 6 months of oral azathioprine (2m...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women with newly diagnosed polyarteritis nodosa or microscopic polyangiitis;
• • absence of poor prognostic factors as defined by the five-factor score (serum creatinine \> 140 μmol/l or 1.58 mg/dl, proteinuria \> 1 g/day, severe gastrointestinal tract involvement, specific cardiomyopathy and/or central nervous system involvement;
• • written informed consent.
• • Both genders eligible;
• • age ≥ 15 years.
• Exclusion Criteria:
• • age \< 15 years, previously treated systemic vasculitis;
• • history of cancer;
• • pregnant or breast-feeding women;
• • psychiatric disorders that might compromise compliance with therapy;
• • contraindication to study drug;
• • other ongoing therapeutic trial;
• • concomitant viral hepatitis B or C or human immunodeficiency virus (HIV) infection