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infliximab + azathioprine (Sapienza University of Rome)
- Development stage
- Phase 4
- Lead developer
- Sapienza University of Rome
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
- Administration
- Intravenous, Oral
01
Overview
Top-down-University of Roma La Sapienza-Crohn's disease refers to a specific therapeutic regimen and clinical trial protocol evaluated by the University of Roma La Sapienza for the treatment of pediatric Crohn's disease. This top-down approach involves the early initiation of combination therapy with infliximab and azathioprine at the time of diagnosis, rather than following the traditional step-up model of starting with corticosteroids. Infliximab is a chimeric monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), a central mediator of inflammation in Crohn's disease. Azathioprine is an immunosuppressive small molecule that acts as a purine analogue, interfering with DNA synthesis and inhibiting the proliferation of inflammatory T-cells. The regimen aims to achieve rapid clinical remission and mucosal healing to prevent long-term complications and growth impairment in pediatric patients with moderate-to-severe disease.
- Other names
- Top-down therapyInfliximab Top-Down vs Step-Up in Pediatric Crohn's Disease trial
02
Targets
IMPDH (Inosine-5'-monophosphate dehydrogenase 1)TNFA (Tumor necrosis factor alpha (soluble))DNA
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