Rituximab in Patients With Acute Rheumatic Fever

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paris Cardiovascular Research Center (Inserm U970)
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Children aged between >= 5 and < 17 years old;

• Diagnosed acute rheumatic fever with at least one progressive rheumatic valvular lesion confirmed through a cardiac echography.

• Informed consent, signed and dated by both parents or legal guardians of the patient

Exclusion Criteria:

• Simultaneous active infection, such as HIV, hepatitis B, C, tuberculosis, Epstein-Barr virus (EBV), or history of frequent, unusual or serious infections ;

• Pathologies likely to affect immunity (cancer, multiple sclerosis, diabetes, other auto-immune diseases)

• Recent history of drug administration that may affect the immune system, for the past 4 weeks (immunosuppressive drugs, corticosteroids, anticancer drugs);

• Hypersensitivity reaction to rituximab or one of its components. Hypersensitivity to penicillin

• History of monoclonal antibodies administration

• Recent vaccination (less than a month) or planned within the 12 months after randomization;

• History of heart failure

• Renal failure with a creatinine clearance <45 ml/min/1,73m²

• Pregnancy (a negative urinary test is necessary for women who had their first menstruations or aged 14 years old and more)

• Patients diagnosed with Guillain-Barré syndrome

• Patient with at least one of the following biological features : Hemoglobin < 8,5 g/dL, Platelets < 100 G/L, Neutrophils < 1,5 G/L, Leucocytes < 3 G/L, AST or ALT increased > 2,5 the normal superior limit)

• Any acute or chronic infection clinically significant which would limitate the patient's capacity to follow up the study protocol, which remains under appreciation of the investigator.

• Any participation in another clinical trial in the 6 months before the pre-randomization visit