Please select the eligibility criteria that correspond to the clinical trial below.
Title: MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis II
Brief Summary: The aim of this study is to assess the efficacy of a rituximab regimen based on rate of ANCA and CD19 lymphocytes for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of two rituximab regimens: one based on ANCA and CD19 lymphocytes versus systematic infusions.


Options:
A: Inclusion Criteria:

* Weight of at least 88 pounds(40 kilograms)
* Diagnosis of Wegener's granulomatosis or microscopic polyangiitis according to the definitions of the Chapel Hill Consensus Conference
* Newly diagnosed patient of Wegener's granulomatosis or microscopic polyangiitis OR must be experiencing a disease flare characterized by: (a) active disease with a Birmingham Vasculitis Activity Score for Wegener's granulomatosis (BVAS/WG) of 3 or greater that would normally require treatment with CYC; OR (b) disease severe enough to require treatment with CYC; OR (c) must be positive for either PR3-ANCA (ANCA directed against proteinase 3) or MPO-ANCA (ANCA directed against myeloperoxidase)at the screening
* Willing to use acceptable forms of contraception for the duration of the study and for up to 1 year after stopping study medications
* Willing to report pregnancies (female participants or male participants' partners) occurring at any time during the study and for up to 1 year after stopping study medications
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* Diagnosis of Churg-Strauss Syndrome according to the definitions of the Chapel Hill Consensus Conference
* Have limited disease that would not normally be treated with CYC
* Requires mechanical ventilation because of alveolar hemorrhage
* History of severe allergic reactions to human or chimeric monoclonal antibodies
* Active systemic infection
* Have a deep-space infection, such as osteomyelitis, septic arthritis, or pneumonia complicated by pleural cavity or lung abscess, within 6 months prior to study entry
* History of or current hepatitis B or C infection
* HIV (human immunodeficiency virus) infected
* Acute or chronic liver disease that, in the opinion of the investigator, may interfere with the study
* History of or active cancer diagnosed within the last 5 years. Individuals with squamous cell or basal cell carcinomas of the skin and individuals with cervical carcinoma in situ who have received curative surgical treatment may be eligible for this study.
* History of anti-glomerular basement membrane (anti-GBM) disease
* Other uncontrolled disease, including drug and alcohol abuse, that may interfere with the study
* Pregnancy or breastfeeding
B: Key Inclusion Criteria:

* Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria.
* Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide.
* Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment.
* Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 21 to 35 days apart.
* Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission.

Key Exclusion Criteria:

* Pregnant or nursing.
* Receipt of a B cell targeted therapy (other than rituximab) at anytime
* Receipt of an investigational biological agent within the past 60 days.
* Required management of acute or chronic infections within the past 60 days.
* Current drug or alcohol abuse or dependence.
* Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* History of severe allergic reaction to contrast agents or biological medicines.
C: Inclusion Criteria:

* Diagnosis of GPA or MPA. Widely accepted diagnostic criteria, as opposed to classification criteria or definitions, have not been developed for GPA and MPA.
* For diagnosis of GPA, meets at least 2 of the following 5 modified American College of Rheumatology (ACR) criteria:

  1. Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood
  2. Abnormal chest radiograph with nodules, fixed infiltrates, or cavities
  3. Urinary sediment with microhematuria or red cell casts
  4. Granulomatous inflammation within the wall of an artery or in the perivascular area on biopsy
  5. Antineutrophil cytoplasmic antibody (ANCA) positive by enzyme immunoassay for either PR3- or MPO-ANCA
* For diagnosis of MPA, meets the Chapel Hill Consensus Conference Definition for MPA:

  1. Necrotizing vasculitis, with few or no immune deposits, that affects small vessels (i.e., capillaries, venules, arterioles)
  2. Necrotizing arteritis involving small- and medium-sized arteries may be present
  3. Necrotizing glomerulonephritis is very common
  4. Pulmonary capillaritis often occurs
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* Simultaneous diagnoses of both GPA and MPA
* Granulomatosis with polyangiitis (Churg-Strauss)
* Takayasu's arteritis
* Giant cell arteritis
* Polyarteritis nodosa
* Cogan's syndrome
* Behcet's disease
* Sarcoidosis
* Kawasaki disease
* Tuberculosis or any atypical mycobacterial infections
* Deep fungal infections
* Lymphoma, lymphomatoid granulomatosis, or any other type of cancer that mimics anti-neutrophil cytoplasmic antibody-associated vasculitis (AAVs)
* Cryoglobulinemic vasculitis
* Systemic lupus erythematosus
* Rheumatoid arthritis
* Mixed connective tissue disease or any overlapping autoimmune syndrome
D: Inclusion Criteria:

* Granulomatosis with Polyangiitis Or microscopic polyangiitis complying Or kidney-limited disease With or without detectable ANCA (anti-neutrophil cytoplasmic antibodies) at the time of diagnosis or relapse, and at remission.
* Who have achieved remission using a treatment combining corticosteroids and an immunosuppressive agent, including corticosteroids, cyclophosphamide IV or oral (the use of another immunosuppressant is allowed, according to the current French guidelines, as well as plasma exchanges and/or IV immunoglobulins, or rituximab).
* Interval of 1 month between the end of the immunosuppressant treatment and the randomization time if cyclophosphamide or methotrexate were used, interval between 4 and 6 months if rituximab was used
* Age \> 18 years without age limit higher when the diagnosis is confirmed.
* Informed and having signed the consent form to take part in the study.

Exclusion Criteria:

* Other systemic vasculitis
* Secondary vasculitis (following neoplastic disease or an infection in particular)
* Induction treatment with a regimen not corresponding to that recommended in France.
* Patient who has not achieved remission.
* Incapacity or refusal to understand or sign the informed consent form.
* Incapacity or refusal to adhere to treatment or perform the follow-up examinations required by the study. Non-compliance
* Allergy, documented hypersensitivity or contraindication to the study medication (cyclophosphamide, corticosteroids, azathioprine, rituximab)
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
* Pregnancy, breastfeeding. Women of childbearing age must use a reliable method of contraception throughout the duration of immunosuppressive treatment up to 1 year after the last infusion of rituximab
* Infection by HIV, HCV or HBV
* Progressive, uncontrolled infection requiring a prolonged treatment (tuberculosis, HIV infection, etc.).
* Severe infection declared during the 3 months before randomization (CMV, HBV, HHV8, HCV, HIV, tuberculosis).
* Progressive cancer or malignant blood disease diagnosed during the 5 years before the diagnosis of vasculitis. Patients suffering from non-metastatic prostate cancer or those cured of a cancer or a malignant blood disorder for more than 5 years and not taking any antineoplastic agents for more than 5 years may be included.
* Participation in another clinical research protocol during the 4 weeks before inclusion.
* Any medical or psychiatric disorder which, in the investigator's opinion, may prevent the administration of treatment and patient follow-up according to the protocol, and/or which may expose the patient to a too greater risk of an adverse effect.
* No social security
* Churg and Strauss syndrome
* Viral, bacterial or fungic or mycobacterial infection uncontrolled in the 4 weeks before the inclusion
* History of deep tissue infection (fasciitis, osteomyelitis, septic arthritis)in the first year before the inclusion
* History of chronic and severe or recurrent infection or history of preexisting disease predisposing to severe infection
* Severe immunodepression
* Administration of live vaccine in the four weeks before inclusion
* Severe chronic obstructive pulmonary diseases (VEMS \< 50 % or dyspnea grade III)
* Chronic heart failure stade III and IV (NYHA)
* History of recent acute coronary syndrome, unrelated to vasculitis

Answer: D