Rituximab Plus Corticosteroids in Non-infectious Active Mixed Cryoglobulinemia Vasculitis (NCT02556866) | Clinical Trial Compass
TerminatedPhase 2
Rituximab Plus Corticosteroids in Non-infectious Active Mixed Cryoglobulinemia Vasculitis
Stopped: lack of recruitment
France14 participantsStarted 2015-07-17
Plain-language summary
Multicenter randomized double-blind study comparing the efficacy and safety of rituximab in combination with corticosteroids to corticosteroids plus placebo in the treatment of non-infectious active mixed cryoglobulinemia vasculitis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient must be at least 18 years of age or older, without any upper age limit
✓. Patient informed and agreed to participate, and gave informed consent,
✓. Patient with active cryoglobulinemia vasculitis define by positive cryoglobulinemia and a clinically active vasculitis with skin, joint, renal, peripheral nerve, central neurological, digestive, pulmonary and/or cardiac involvement (no histological evidence needed if presence of purpura demonstrated),
✓. Patient with primary Sjögren's syndrome, systemic lupus erythematosus, or another auto-immune disease, or B-cell non-Hodgkin lymphoma (with cryoglobulinemia as the only therapeutic indication), or essential mixed cryoglobulinemia,
✓. Naive or relapsing patients, without modification (initiation or increase) of immunosuppressive therapy in the month prior the inclusion,
✓. For women of child bearing age: negative pregnancy test during the inclusion, and effective contraception during the period of 12 months after the latest rituximab infusion or placebo,
✓. Patients with severe vasculitis must be treated in the 15 days prior inclusion by 3 bolus of methylprednisolone (15 mg/kg/d) AND 3 to 7 plasma exchanges (exchange volume of 60 ml/kg/session).
Exclusion criteria
✕. Patient with a medium and small size vessels vasculitis unrelated to cryoglobulinemia (granulomatous with polyangiitis (Wegener's disease), microscopic polyangiitis, eosinophilic granulomatous with polyangiitis (Churg-Strauss syndrome), polyarteritis nodose, IgA vasculitis, hypersensitivity vasculitis, infectious vasculitis, hypocomplementemic urticarial vasculitis),
What they're measuring
1
Complete clinical response of vasculitis symptoms (yes-no, i.e. success-failure) with corticosteroid withdrawal (prednisone at 0 mg/day) at week (W) 24, with at least one clinical response at W4
✕. Patient with a large size vessels vasculitis,
✕. Patient with non active cryoglobulinemia vasculitis,
✕. Patient with immunosuppressive therapy introduced or increased in the month prior to the inclusion,
✕. Patients receiving corticosteroid therapy \> 0.5 mg/kg/d for more than one month before the inclusion or \> 1 mg/kg/d for more than two weeks before the inclusion,
✕. Patient who had received rituximab therapy within the 12 months before the inclusion,
✕. Pregnancy in progress or needed , breast feeding,