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

Microscopic Polyangiitis Clinical Trial

Official title:

CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00400075
• Other study ID #: 95.067/2
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 14, 2006
• Last updated: November 15, 2006
• Start date: July 1996

Study information

• Verified date: November 2006
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 90 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Microscopic Polyangiitis
• Polyarteritis Nodosa
• Systemic Vasculitis

Intervention

Drug:
• azathioprine

• cyclophosphamide

Locations

Country	Name	City	State
Switzerland	Camillo Ribi	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival, relapse rate and adverse events, measured at study end (mean follow-up of 5 years)