Combined Immunosuppression for Pediatric Crohn's Disease
This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.
| Condition(s) | Crohn Disease, Infliximab, Immunosuppression, Children, Only |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease. |
| Who can participate | Inclusion Criteria: 1. 6-18 years old 2. diagnosis of Crohn's Disease 3. Pediatric Crohn's disease Activity Index (PCDAI)\>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) \>10 before treatment 4. receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatric Crohn's disease Activity Index (PCDAI)\>10 or The Simple Endoscopic Score for Crohn Disease (SES-CD)≥3 after exclusive enteral nutrition or corticosteroids 5. The patient or legal guardian sign the informed consent documents Exclusion Criteria: 1. history of biological agents targeting at tumor necrosis factor (TNF) 2. Crohn's Disease-related surgery 3. infections 4. tumors |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Lead sponsor | Children's Hospital of Fudan University |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2022-10-10 |
| NCT ID | NCT05043870 |
| Official listing | https://clinicaltrials.gov/study/NCT05043870 |