Status:
UNKNOWN
CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Polyarteritis Nodosa
Microscopic Polyangiitis
Eligibility:
All Genders
15-90 years
Phase:
PHASE4
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 1996
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00400075
Start Date
July 1 1996
Last Update
November 16 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Camillo Ribi
Geneva, Switzerland