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Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy

Phase 4
18 Years
60 Years
Open (Enrolling)
Vasculitis, Microscopic Polyangiitis, Granulomatosis With Polyangiitis, Wegener's

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Trial Information

Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy

Inclusion Criteria:

1. A diagnosis of AAV, according to a standardized definition

2. Active vasculitis with at least one severe or three non severe items of BVAS/WG
activity (equivalent to BVAS/WG>3)

3. Previous therapy with either cyclophosphamide or methotrexate, in combination with
prednisolone for at least 3 months.

Exclusion Criteria:

1. Age less than 18 or greater than 60 years

2. Creatinine > 150╬╝mol/l (1.7mg/dl)

3. Total white count < 4x109/l or lymphocyte count < 0.5x109/l, or IgG < 5g/L, or
neutrophil count < 1.5x109/l.

4. Severe lung haemorrhage with hypoxia (<85% on room air)

5. Severe gastrointestinal, central nervous system or cardiac vasculitis

6. Previous therapy with:

1. Alemtuzumab at any time

2. IVIg, infliximab, etanercept, adalimumab, abatacept, anti-thymocyte globulin or
plasma exchange in past three months

3. Rituximab within the past 6 months

7. Intensive care unit requirement

8. Active infection with HIV, hepatitis B or hepatitis C or other infection requiring
parenteral or long-term oral antibiotics

9. History of ITP or platelet count at screening below 50,000 x 106/l

10. Pregnancy or inadequate contraception in pre-menopausal women

11. Breast feeding

12. Any condition judged by the investigator that would cause the study to be detrimental
to the patient.

13. Any other multisystem autoimmune disease including Churg Strauss angiitis, systemic
lupus erythematosus, anti-GBM disease and cryoglobulinaemia

14. Any previous or current history of malignancy (other than resected basal cell

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with a vasculitis response at 6 months

Outcome Description:

Response includes patients in complete and partial remission. Complete remission (CR) is defined as a BVAS/WG of 0 for at least one month. Partial response (PR) is the absence of severe BVAS/WG items and at least 50% fall in BVAS/WG score from baseline.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

David RW Jayne, MD MRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cambridge University Hospitals NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

February 2011

Completion Date:

March 2014

Related Keywords:

  • Vasculitis
  • Microscopic Polyangiitis
  • Granulomatosis With Polyangiitis
  • Wegener's
  • Vasculitis
  • ANCA
  • Refractory
  • Vasculitis
  • Wegener Granulomatosis
  • Systemic Vasculitis
  • Microscopic Polyangiitis