Table 5

Inclusion criteria for other remission induction studies

Study ID

Inclusion criteria

Exclusion criteria


Hu 2008

Newly diagnosed active ANCA associated vasculitis.

Over 18 years of age with renal involvement

with serum creatinine < 500 uM.

ANCA positive or ANCA negative with confirmatory

renal Biopsy

Cytotoxic drug treatment in 6 months prior.

HBV, HCV, HIV or active CMV viral infection,

acquired immune deficiency, severe renal failure

with creatinine > 500 uM or on renal replacement

therapy, life-threatening organ manifestations

(lung haemorrhage or CNS involvement), active TB,

liver dysfunction, pregnancy or inadequate

contraception if female, under age 18 or over 65.

Jones 2008

(RITUXVAS)

A new diagnosis of Wegener's Granulomatosis (WG),

Microscopic Polyangiitis (MP) or Renal-Limited

Vasculitis (RLV)

Renal involvement attributable to active WG, MP or

RLV with at least one of the following:

Biopsy demonstrating necrotizing glomerulonephritis

Red cell casts on urine microscopy or ≥++ haematuria

Anti-Neutrophil Cytoplasmic Antibodies (ANCA) positivity;

ANCA positivity requires either:

Proteinase 3 anti-neutrophil cytoplasmic antibody

(PR3-ANCA) by Enzyme-Linked Immunosorbent Assay (ELISA)

or a typical anti-neutrophil cytoplasmic antibody (cANCA)

pattern by indirect immunofluorescence (IIF), or both

Myeloperoxidase-anti-neutrophil cytoplasmic antibody

(MPO-ANCA) by ELISA. A positive peri-nuclear anti-neutrophil

cytoplasmic antibody (pANCA) by IIF requires

confirmation by MPO-ANCA ELISA.

1. Previous cyclophosphamide, (greater than

two weeks of an oral or intravenous [IV] pulse

cyclophosphamide regimen)

2. Co-existence of another multi-system autoimmune

disease, e.g. SLE, Churg Strauss syndrome, Henoch

Schonlein purpura, rheumatoid vasculitis, essential

mixed cryoglobulinaemia, anti-glomerular basement

membrane antibody positivity

3. Hepatitis B antigen positive or hepatitis C

antibody positive

4. Known HIV positive (HIV testing will not

be a requirement for this trial)

5. Previous malignancy (usually exclude unless

agreed with trial co-ordinator)

6. Pregnancy, breast feeding or inadequate contraception if female

7. Allergy to a study medication

8. Live vaccine within last four weeks

Stone 2009

(RAVE)

Weight of at least 88 lbs (40 kg). Diagnosis of

Wegener's granulomatosis (WG) or microscopic polyangiitis

(MPA) according to the definitions of the Chapel Hill

Consensus Conference. Newly diagnosed patient of WG or MPA

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 CPA; OR (b) disease

severe enough to require treatment with CPA; OR (c) must be

positive for either PR3-ANCA or MPO-ANCA 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.

Churg-Strauss Syndrome

Limited disease that would not normally be treated with CPA.

Mechanical ventilation because of alveolar haemorrhage

History of severe allergic reactions to human or chimeric

monoclonal antibodies.

Active systemic infection.

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 infected. Acute or chronic liver disease.

History of or active cancer diagnosed within the last 5 years.

History of anti-glomerular basement membrane (anti-GBM) disease.

Other uncontrolled disease, including drug and alcohol abuse.

Pregnancy or breastfeeding.

Jayne

2000

Prior diagnosis of Wegener's granulomatosis or

microscopic polyangiitis

ANCA positivity at diagnosis.

Active vasculitis with a requirement for

further therapy.

At least 2 months treatment with prednisolone and

cyclophosphamide or azathioprine

Age 18 or over

IVIg in previous 3 months history of

anaphylaxis to matched blood products

selective IgA deficiency RPGN (20% rise

in creatinine in 2 weeks) or pulmonary haemorrhage.

Furuta

1998

Biopsy proven rapidly progressive GN.

None Stated

Stegmayr

1999

RPGN ≥ 50% crescents; included WG,

Goodpasture's syndrome, MPA

HIV, hepatitis A, B or C virus, severe congestive

heart failure, malignancy, septicaemia.


Walters et al. BMC Nephrology 2010 11:12   doi:10.1186/1471-2369-11-12

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