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

Phase 4

• Conditions: Polyarteritis Nodosa; Microscopic Polyangiitis

• Registration Number: NCT00400075
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

To assess the efficacy of systemic corticosteroids alone as first-line treatment of polyarteritis nodosa and microscopic polyangiitis without poor-prognosis factors as defined by the five-factor score (FFS=0), and to compare the efficacy and safety of azathioprine vs pulse cyclophosphamide as adjunctive immunosuppressive therapy to treat failure or relapse.

Detailed Description

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 (2mg/kg/day) or 6 cyclophosphamide pulses (0.6g/m2 D1, D15, D30 then every month)

Study Timeline

• Study Start: 1996-07
• Status Verified: 2006-11
• Study First Submitted: 2006-11-14
• Study First Submitted QC: 2006-11-15
• Last Update Submitted: 2006-11-15
• Study First Posted: 2006-11-16
• Last Update Posted: 2006-11-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of events (failures, relapses and/or deaths) occurring in each group, defining the disease-free survival rate, measured at study end (mean follow-up of 5 years)

Secondary Outcome Measures

Name	Time	Method
Overall survival, relapse rate and adverse events, measured at study end (mean follow-up of 5 years)

Trial Locations

Locations (1)

Camillo Ribi; 🇨🇭 Geneva, Switzerland