drugset / Trial / NCT05682196

Rituximab in Patients With Acute Rheumatic Fever

NCT05682196 ↗

Phase 2 Suspended 234 enrolled African Academy of Methodology and Statistics
RandomizedParallel-groupDouble-blindTreatment

Summary

Acute Rheumatic Fever is an autoimmune inflammatory post-infectious syndrome, mainly caused by type A streptococcus. It is characterized as an inadequate immune response. It may provoke carditis, combined with articular, skin and neurologic signs. Only carditis, prevalent in 60% of acute rheumatic diseases, may provoke valvular sequels, which define rheumatic cardiopathy. Antibiotherapy based on penicillin is the standard treatment of both acute rheumatic fever and its prevention. Although no anti-inflammatory treatment has proved its efficacy, with or without steroids anti-inflammatory treatments are administered in acute episode of ARF. Up to date, only prevention strategies have shown efficacy.

Timeline

Start
2023-01-05
Primary completion
2024-09-30
Completion
2025-02-01

Outcome

Outcome not reported

Stopped: “ethical controversy”

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous