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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2015
Main ID:  NCT00647166
Date of registration: 26/03/2008
Prospective Registration: Yes
Primary sponsor: Assistance Publique - Hôpitaux de Paris
Public title: Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) CHUSPAN2
Scientific title: Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) Without Poor Prognosis Factors
Date of first enrolment: May 2008
Target sample size: 114
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00647166
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
France
Contacts
Name:     Loic Guillevin, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  French Vasculitis Study Group
Key inclusion & exclusion criteria

Inclusion Criteria:

- male or female patients

- aged over 18 years

- new diagnosis of microscopic polyangiitis, polyarteritis nodosa or eosinophilic
granulomatosis with polyangiitis (Churg Strauss syndrome), satisfying ACR 1990 and/or
Chapel Hill Nomenclature criteria (positive biopsy is not mandatory providing those
criteria are fulfilled)

- with no factor of poor prognosis according to the French five factors score (FFS=0)

- at diagnosis or within the first 21 days following initiation of corticosteroids

- signed information and consent form

- patients covered by Health Insurance

- having had a baseline physical examination

Exclusion Criteria:

- patients with microscopic polyangiitis, polyarteritis nodosa or eosinophilic
granulomatosis with polyangiitis (Churg Strauss syndrome) with one or more factor(s)
of poor prognosis according to the French five factors score (FFS = 1)

- patients with polyarteritis nodosa with ANCA, not satisfying the criteria for
microscopic polyangiitis

- patients with clinically overt alveolar hemorrhage or respiratory distress syndrome

- patient treated with corticosteroids for more than 15 days or already receiving
another immunosuppressant

- relapsing vasculitis

- other vasculitis, especially secondary vasculitides

- vasculitis secondary or associated with a viral infection, such as hepatitis B or C
virus, or HIV

- malignancy

- pregnancy and breast feeding,women of child-bearing age not willing or with
contra-indication to receive contraception

- contra-indication to any of the study agents

- need to continue allopurinol for those patients taking allopurinol

- consent deny or inability to receive information and give consent

- participation in another concomitant therapeutic trial

- no affiliation to any of the general French health care system



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids
MPA
PAN or EGPA With FFS=0
Intervention(s)
Drug: corticosteroid and azathioprine
Drug: corticosteroid and placebo
Primary Outcome(s)
combined rate of remission-treatment failures and minor or major relapses at 24 months [Time Frame: 24 months]
Secondary Outcome(s)
area under the curve for corticosteroids [Time Frame: 24 months]
different scales, such as BVAS (activity of the disease), VDI (damage), HAQ, SF36, ADL and the evaluation of the need for health care facilities. [Time Frame: 24 months]
initial remission rate (independently of subsequent relapse) [Time Frame: 24 months]
number of deaths and causes [Time Frame: 24 months]
number of flares with or without asthma and/or eosinophilia (only for EGPA analysis) [Time Frame: 24 months]
number of patients who could not be weaned of corticosteroids and dose required [Time Frame: 24 months]
number of patients who have a minor or major relapse [Time Frame: 24 months]
number of patients with at least one treatment-related adverse effect [Time Frame: 24 months]
number of serious treatment-related adverse effects [Time Frame: 24 months]
severity of treatment-related effects according to the WHO toxicity grading system (grades 1 to 4; grades 3 and 4 for the severity) [Time Frame: 24 months]
Secondary ID(s)
P 060243
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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