Back to resultsCHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors
Primary Purpose
Polyarteritis Nodosa, Microscopic Polyangiitis
Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
azathioprine
cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Polyarteritis Nodosa focused on measuring Polyarteritis, Vasculitis, Therapy, Cyclophosphamide, Azathioprine
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
Sites / Locations
- Camillo Ribi
Outcomes
Primary Outcome Measures
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
Overall survival, relapse rate and adverse events, measured at study end (mean follow-up of 5 years)
Full Information
NCT ID
NCT00400075
First Posted
November 14, 2006
Last Updated
November 15, 2006
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT00400075
Brief Title
CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors
Official Title
CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyarteritis Nodosa, Microscopic Polyangiitis
Keywords
Polyarteritis, Vasculitis, Therapy, Cyclophosphamide, Azathioprine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
azathioprine
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Overall survival, relapse rate and adverse events, measured at study end (mean follow-up of 5 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François Cordier, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Camillo Ribi
City
Geneva
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
25153486
Citation
Samson M, Puechal X, Devilliers H, Ribi C, Cohen P, Bienvenu B, Terrier B, Pagnoux C, Mouthon L, Guillevin L; French Vasculitis Study Group (FVSG). Mononeuritis multiplex predicts the need for immunosuppressive or immunomodulatory drugs for EGPA, PAN and MPA patients without poor-prognosis factors. Autoimmun Rev. 2014 Sep;13(9):945-53. doi: 10.1016/j.autrev.2014.08.002. Epub 2014 Aug 19.
Results Reference
derived
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CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors
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