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ACTIVE NOT RECRUITING
NCT05329090
PHASE3

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

Sponsor: Hopital Foch

View on ClinicalTrials.gov

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

DRUG

Rituximab Injection

anti-CD20 monoclonal antibody leading to B-cell depletion, in relapsing and/or refractory IgAV patients

DRUG

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