Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome)

• 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
• 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 placebo

Drug: corticosteroid and azathioprine

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]

number of patients with at least one treatment-related adverse effect [Time Frame: 24 months]

number of flares with or without asthma and/or eosinophilia (only for EGPA analysis) [Time Frame: 24 months]

initial remission rate (independently of subsequent relapse) [Time Frame: 24 months]

number of patients who could not be weaned of corticosteroids and dose required [Time Frame: 24 months]

number of deaths and causes [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]

number of serious treatment-related adverse effects [Time Frame: 24 months]

number of patients who have a minor or major relapse [Time Frame: 24 months]

Secondary ID(s)

P 060243

Source(s) of Monetary Support

Please refer to primary and secondary sponsors