Evaluation of Glucocorticoids Plus Rituximab in Patients With Newly-Diagnosed or Relapsing IgA Vasculitis

Sponsor
Hopital Foch
Study ID
NCT05329090
Phase
PHASE3
Status
Completed

Conditions

  • IgA Vasculitis

Eligibility Criteria

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

Interventions

  • Rituximab Injection — DRUG
    anti-CD20 monoclonal antibody leading to B-cell depletion, in relapsing and/or refractory IgAV patients
  • placebo — DRUG
    placebo experimental treatment

Study Details

Systemic vasculitis are inflammatory diseases of the blood vessels, responsible for systemic manifestations. Among the systemic vasculitis affecting small blood vessels, IgA vasculitis (IgAV) is one of the most common forms and mainly affects the skin, joints, kidneys and gastrointestinal tract. Kidney and gastrointestinal damage can be serious, causing complications and life-threatening sequelae, especially in adults. The treatment of adult-onset IgAV is still a matter of debate. Glucocorticoids have been the standard of care for inducing remission for years in severe forms of IgAV. However, not all patients achieve remission and may experience disease flares associated with increased morbidity and mortality. In addition, the cumulative side effects of glucocorticoids are also major causes of long-term adverse events and death.Rituximab (RTX), an anti-CD20 monoclonal antibody, has been shown to be spectacularly effective in inducing remission in d 'other small vascular vessels, in particular ANCA-associated vasculitis and cryoglobulinemic vasculitis, with an acceptable safety profile. Recently, a multicenter observational study suggested that RTX was an effective and safe therapeutic option for treating relapsed and / or refractory adult IgAV. Overall, RTX may be an effective and safe therapeutic approach in adult IgAVs, justifying the need for a prospective randomized controlled trial evaluating Rituximab as an induction of remission for adult IgAV.

Key Dates

Start date
Mar 11, 2022
Status verified
Jun 2026
Primary completion
Jan 13, 2026
Completion
Jan 13, 2026

Study Design

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

Arms

  • Experimental: experimental group
    Experimental therapeutic strategy based on the use of rituximab in combination with glucocorticoids
  • Placebo Comparator: control group
    Control therapeutic strategy based on glucocorticoids plus placebo

Primary Outcome Measure

Rituximab efficacy [ Time Frame: 180 days ]

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