Rituximab Plus Corticosteroids in Non-infectious Active Mixed Cryoglobulinemia Vasculitis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT02556866
Phase
PHASE2
Status
Terminated

Conditions

  • Cryoglobulinemia
  • Systemic Vasculitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    Prednisone treatment plus rituximab administered by slow intravenous infusion at 375 mg/m2 at D1, D8, D15 and D22.
  • Prednisone — DRUG
  • Placebo — DRUG

Study Details

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.

Key Dates

Start date
Jul 17, 2015
Status verified
Mar 2019
Primary completion
May 31, 2018
Completion
May 31, 2018

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: rituximab
    Prednisone treatment plus rituximab administered by slow intravenous infusion at 375 mg/m2 at D1, D8, D15 and D22.
  • Placebo Comparator: placebo
    Prednisone treatment plus placebo administered by slow intravenous infusion at day 1 (D1), D8, D15 and D22.

Primary Outcome Measure

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 [ Time Frame: Week 24 ]

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