Please select the eligibility criteria that correspond to the clinical trial below.
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
Brief Summary: To determine whether a combination of corticosteroids and azathioprine can achieve a higher remission rate and a lower subsequent relapse rate in patients with newly-diagnosed microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) with no poor prognosis factor (FFS=0), and without significantly increasing the rate of adverse events, as compared to corticosteroids alone. The study hypothesis is a reduction of the absolute risk of treatment failure or relapse within the first 24 months following initiation of therapy of least 25%.


Options:
A: Inclusion Criteria:

* Diagnosis of Wegener's granulomatosis or microscopic polyangiitis, using criteria adapted by EUVAS from the disease definitions of the Chapel Hill consensus conference
* Biopsy proven, pauci-immune, necrotising and/or crescentic glomerulonephritis, in the absence of other defined glomerulopathy
* Severe renal impairment defined by: (i) oliguria (\<400ml/24hr), or (ii) intention to commence dialysis within 48 hours of admission, and (iii) creatinine \>500umol/l (5.8mg/dl).

Exclusion Criteria:

* Age under 18 or over 80 years
* Inadequate contraception in women of child-bearing age
* Pregnancy
* Previous malignancy
* Hepatitis B antigenaemia, anti-hepatitis C virus or anti-human immunodeficiency virus antibody
* Diagnosis of Churg-Strauss syndrome, Henoch-Schönlein purpura, rheumatoid vasculitis, mixed essential cryoglobulinaemia or systemic lupus erythematosus
* Circulating anti-GBM antibodies or linear IgG staining of the GBM on renal biopsy
* Life-threatening non-renal manifestations of vasculitis, including alveolar hemorrhage requiring mechanical ventilation within 24 hours of admission
* On dialysis for \> two weeks prior to entry
* Creatinine \> 200umol/l (2.3mg/dl) one year or more before entry
* A second clearly defined cause of renal failure
* Previous episode of biopsy-proven necrotising and/or crescentic glomerulonephritis
* \> two weeks treatment with cyclophosphamide or azathioprine
* \> 500mg IV methyl prednisolone
* Plasma exchange within the preceding year
* \> three months treatment with oral prednisolone
* Allergy to study medications.
B: 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
C: Inclusion Criteria:

* Documented diagnosis of Wegener's granulomatosis (now called Granulomatosis with Polyangiitis), microscopic polyangiitis or renal limited vasculitis according to Chapel Hill Consensus Conference criteria.
* In stable remission (no documented clinical disease activity) for at least 6 months prior to entry.
* On maintenance immunosuppression with prednisolone, mycophenolate mofetil or azathioprine alone or in combination (maximum 2 agents).
* Documented evidence of CMV infection (CMV-specific immunoglobulin G detected in peripheral blood).
* Documentation that female patients of child bearing potential are not pregnant and using an appropriate form of contraception.
* Written informed consent for study participation

Exclusion Criteria:

* Stage 5 chronic kidney disease (eGFR\<15ml/minute/1.73m2).
* Other significant chronic infection (HIV, HBV, HCV, TB).
* B-cell or T-cell depleting therapy within 12 months.
* Treatment with anti-CMV therapies in last month
* Underlying medical conditions, which in the opinion of the Investigator place the patient at unacceptably high risk for participating in the study.
* Inability to fully or appropriately participate in the study.
D: Inclusion Criteria:

* Newly diagnosed patients with WG, MPA or renal-limited vasculitis.
* ANCA positivity. ANCA positivity requires PR3-ANCA or a typical cANCA pattern by indirect immunofluorescence (IIF), preferably confirmed by anti-PR3 ELISA. MPO-ANCA determined by ELISA requires demonstration of pANCA, and pANCA by IIF requires confirmation by anti-MPO ELISA. Optionally, central review of ANCA serology can be performed.
* Age 18 to 75 years

Exclusion Criteria:

* Any cytotoxic drug within previous year, unless started within one months of entry and according to the protocol design
* Co-existence of another systemic autoimmune disease, e.g. SLE
* Hepatitis B or Hepatitis C infection
* HIV positivity
* Failure to achieve remission after 6 months of CYC therapy
* Failure to control progressive disease with induction protocol
* Malignancy (usually exclude unless agreed with trial co-ordinator)
* Pregnancy or inadequate contraception
* Age below 18 and above 75 years\*
* Endstage renal failure unless active extrarenal disease requires treatment (temporal dependency of hemodialysis is not an exclusion criterion)
* Inability for informed consent

  * After discussion with the trial administrator, patients less than 18 years may be incorporated on separate application according to the appropriate local ethic committee.

Answer: B