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Evaluation of Glucocorticoids Plus Rituximab in Patients with Newly-Diagnosed or Relapsing IgA Vasculitis
Sponsor: Hopital Foch
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.
Official title: Evaluation of Glucocorticoids Plus Rituximab Compared to Glucocorticoids Plus Placebo for the Treatment of Patients with Newly-Diagnosed or Relapsing IgA Vasculitis: a Prospective, Randomized, Controlled, Double-blind Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2022-03-11
Completion Date
2026-01-16
Last Updated
2025-03-13
Healthy Volunteers
No
Conditions
Interventions
Rituximab Injection
anti-CD20 monoclonal antibody leading to B-cell depletion, in relapsing and/or refractory IgAV patients
placebo
placebo experimental treatment
Locations (14)
Hopital La Cavale Blanche
Brest, France
CHU Clermont Ferrand
Clermont-Ferrand, France
CHU Clermont Ferrand
Clermont-Ferrand, France
Hôpital Edouard Herriot
Lyon, France
CHU Marseille
Marseille, France
APHM de La Timone
Marseille, France
Hôpital André Grégoire
Montreuil, France
CHU Nantes
Nantes, France
CHU Nîmes (Caremeau)
Nîmes, France
Hôpital Cochin
Paris, France
CHU Strasbourg
Strasbourg, France
Hôpital Foch
Suresnes, France
CHU Toulouse
Toulouse, France
CHRU Bretonneau
Tours, France