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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Azathioprine; Cyclophosphamide

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