ANCA-associated vasculitis (AAV) MedDRA version: 12 Level: LLT Classification code 10050894 Term: Anti-neutrophil cytoplasmic antibody positive vasculitis
Conditions
Interventions
Trade Name: MabCampath (alemtuzumab)
Product Name: Alemtuzumab (MabCampath)
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Addenbrooke's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A diagnosis of ANCA associated vasculitis 2) Active vasculitis with a least one severe or three non-severe items of BVAS/WG activity (a validated disease activity measure) 3) Previous therapy with either cyclophosphamide or methotrexate, in combination with prednisolone, for at least 3 months 4) Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Age less than 18 years or greater than 60 years 2) Creatinine > 150µmol/l 3) Total white cell count < 4x10^9/l or lymphocyte count < 0.5x10^9/l or neutrophil count < 1.5x10^9/l or IgG < 5g/l 4) Severe lung haemorrhage with hypoxia (oxygen saturations < 85% on room air) 5) Severe gastrointestinal, central nervous system or cardiac vasculitis 6) Previous therapy with: a) Alemtuzumab at any time b) IVIg, infliximab, etanercept, adalimumab, abatacept, anti-thymocyte globulin or plasma exchange in the past 3 months c) Rituximab within the past 6 months 7) Intensive care unit requirement 8) Active infection with HIV, hepatitis B or C or other infection requiring parenteral or long term oral antibiotics 9) History of ITP or platelet count at screening below 50,000 x10^6/l 10) Pregnancy or inadequate contraception in pre-menopausal women 11) Breast feeding 12) Previous history of malignancy 13) Any other mulitsystem autoimmune disease, including Churg Strauss angiitis, systemic lupus erythematosus, anti-GBM disease and cryoglobulinaemia 14) Any condition judged by the investigator that would cause the study to be detrimental to the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: There are 2 principal questions that this research will address: 1) Does alemtuzumab control ANCA associated vasculitis and provide a treatment free sustained remission, in patients that have disease resistant to current standard therapy? 2) Is this achieved with an acceptable level of serious adverse events (at or below levels seen with standard therapy)? ; Secondary Objective: Secondary endpoints include: 1. The proportion of patients with treatment failure 2. The accrual of damage 3. The time to partial remission, time to complete remission and time to flare 4. Cumulative glucocorticoid exposure 5. The proportion of subjects with non-severe adverse events 6. Impact on quality of life assessments 7. Biomarker studies - including lymphocyte phenotyping of recovering cells and gene expression profiling. ; Primary end point(s): 1) Proportion of subjects with a severe adverse event - assessed at 6 and 12 months 2) Proportion of subjects with a vasculitis response at 6 months (Response is defined by a >50% reduction in BVAS/WG score from baseline which is sustained for at least 1 month) | — |
Countries
United Kingdom
Outcome results
None listed