Microscopic Polyangiitis Clinical Trial
Official title:
Randomized Trial of Intravenous Pulse Versus Oral Continuous Cyclophosphamide for Induction of Remission in Systemic ANCA-Associated Vasculitides
A comparison of intermittent pulsed cyclophosphamide to daily oral cyclophosphamide for the
treatment of ANCA-associated systemic vasculitides with kidney involvement.
Performed by the European Vasculitis Study group.
The primary, ANCA-associated systemic vasculitides (AASV), including Wegener’s
granulomatosis and microscopic polyangiitis, are progressive, multisystem, autoimmune
diseases which respond to immunosuppressive therapy. Their treatment with corticosteroids
and cytotoxic drugs has been standardised in a first wave of studies (ECSYSVASTRIAL
project), but limitations of such regimens include only partial efficacy and appreciable
treatment-related toxicity.
The present trial, CYCLOPS, aims to reduce the cumulative exposure to immunosuppressive
drugs by administering cyclophosphamide (CYC) as intermittent pulses. The potential benefit
of using CYC in this way for AASV has been demonstrated in preliminary, smaller studies.
Patients with previously untreated AASV and, “generalised”, but not life threatening,
disease with renal involvement, will be randomised to either continuous oral CYC or
intermittent pulse CYC. CYC will be continued until three months after remission has been
achieved, with a minimum CYC total duration of six months and maximum duration of twelve
months; both limbs will then receive the same maintenance regimen of azathioprine and
prednisolone.
The study will last 18 months. The primary end-point is the disease-free period, taken as
the period of time from remission until relapse or study end; secondary end-points are
adverse effects, cumulative damage and immunosuppressive drug exposure. 160 patients will be
required.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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