NCT00400075

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1996

Completed
10.4 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2006

Completed
Last Updated

November 16, 2006

Status Verified

November 1, 2006

First QC Date

November 14, 2006

Last Update Submit

November 15, 2006

Conditions

Polyarteritis NodosaMicroscopic Polyangiitis

Keywords

PolyarteritisVasculitisTherapyCyclophosphamideAzathioprine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

Interventions

azathioprineDRUG
cyclophosphamideDRUG

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camillo Ribi

Geneva, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 25153486DERIVED

MeSH Terms

Conditions

Polyarteritis NodosaMicroscopic PolyangiitisVasculitis

Interventions

AzathioprineCyclophosphamide

Condition Hierarchy (Ancestors)

ArteritisVascular DiseasesCardiovascular DiseasesSystemic VasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Jean-François Cordier, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2006

First Posted

November 16, 2006

Study Start

July 1, 1996

Last Updated

November 16, 2006

Record last verified: 2006-11

Locations

CH(1)