Active — Not RecruitingPhase 3

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

France75 participantsStarted 2022-03-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Biopsy-proven diagnosis of IgAV according to Chapel Hill Consensus Conference definitions * Patient aged of 18 years or older * Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an active disease defined by active manifestations attributable to IgAV * Patients with severe involvement of at least one organ * Patients within the first 21 days following initiation/increase of glucocorticoids at a dose \< 1 mg/kg/day * Has signed an informed consent form prior to any study related procedures * Affiliated to a national health insurance Exclusion Criteria: * Patients with ANCA-associated vasculitis, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference, * Patients with IgAV in remission of the disease, * Patients with severe cardiac failure defined as class IV in New York Heart Association, * Patients with severe, uncontrolled cardiac disease, * Patients with acute infections or chronic active infections (including HIV, HBV or HCV), * Patients with active cancer or recent malignancy (\<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment, * Pregnant women and breastfeeding. Patients with childbearing potential must use reliable contraceptive methods throughout the study and at least for 12 months after the last study drug administration, * Patients with IgAV who have already been treated with rituximab within the previous 1…

What they're measuring

Rituximab efficacy

Timeframe: 180 days

Rituximab efficacy

Timeframe: 360 days

Trial details

NCT IDNCT05329090

SponsorHopital Foch

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-16