Rituximab in Patients With Acute Rheumatic Fever
- Sponsor
- African Academy of Methodology and Statistics
- Study ID
- NCT05682196
- Phase
- PHASE2
- Status
- Suspended
Conditions
- Rheumatic Heart Disease in Children
Eligibility Criteria
- Sex
- ALL
- Age
- 5 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab added to standard of care treatment — DRUGRituximab with standard of care treatment
- standard of care treatment alone — DRUGStandard of care treatment alone
Study Details
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.
Key Dates
- Start date
- Jan 5, 2023
- Status verified
- Jun 2024
- Primary completion
- Sep 30, 2024
- Completion
- Feb 1, 2025
Study Design
- Enrollment
- 234 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Rituximab plus standard of care (RTX)Rituximab i.v of two perfusions (375 mg/m²) administered in a 14 day-interval added to a standard of care treatment
- Active Comparator: Standard of care treatment (Control)Standard of care treatment
Primary Outcome Measure
Rheumatic valvular lesions rate [ Time Frame: 6 months post randomization ]