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Updated on 2.3..2008
Active Clinical Trials
Please, contact the clinical trials administration office for information on actively recruiting centres.
Trials actively recruiting:
REMAIN (long-term low dose immunosuppression versus treatment withdrawal for renal vasculitis). The protocol was revised in January 2006.
MYCYC (Randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis). The first patient was inclueded in June 2007. A report on MYCYC's progress appears regularly.
ABAVAS (Randomised placebo controlled clinical trial of abatacept in ANCA associated vasculitis) assesses the relapse rate of ANCA associated vasculitis after 12 months of treatment with either abatacept or placebo both in combination with corticosteroid and methotrexate. Inclusion started in October 2007.
Trials having completed recruitment:
IMPROVE (International Mycophenolate mofetil to Reduce Outbreaks of Vasculitides) compares mycophenolate mofetil with azathioprine for remission therapy in renal vasculitis. Inclusions were competed in 2004 and last patient visits are planned at the end of 2008.
RITUXVAS compares a rituximab based regimen with a standard cyclophophamide/ azathioprine regimen in the treatment of active, ‘generalised’ ANCA associated vasculitis. Inclusion was completed in June 2007.
Parallel studies:
DISEASE ASSESSMENT (Development of Disease Assessment in Systemic Vasculitis) Birmingham Vasculitis Activity Score 2003 (BVAS 2003) and the Combined Damage Assessment Index (CDA) are being formally validated in a separate clinical trial of both assessement forms. Inclusion of patients is ongoing and additional centres are invited to participate.
STAVE A meta-analysis of the effect of different corticosteroid dosing regimens on relapses.
LONGTERM FOLLOW-UP A variety of questions are adressed by analysing the merged database of completed EUVAS trials.
HISTOPATHOLOGY: Renal histopathology from the clinical trials is correlated to clinical and laboratory outcomes.
Contact: Ingeborg Bajema