Crohn Disease Clinical Trial
Official title:
Combination Therapy of Infliximab and Immunosuppressives 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.
Status | Recruiting |
Enrollment | 128 |
Est. completion date | December 31, 2025 |
Est. primary completion date | October 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | infliximab concentration | The infliximab (IFX) concentration and anti-infliximab antibodies (ATI) were measured before the infusion of week 14, 38. | week 14, 38 | |
Other | adverse events | The rate of the potential adverse events were monitored during the intervention. | within one year | |
Primary | clinical remission | The clinical remission rate at week 54 | week 54 | |
Primary | endoscopic remission | The endoscopic remission rate at week 54 | week 54 | |
Secondary | Pediatric Crohn's disease Activity Index score | The Pediatric Crohn's disease Activity Index (PCDAI) was assessed at each infusion point. PCDAI score ranges from 0 to 100, the higher means the worse outcome. | week0, week2, week6, week14, week22, week30, week38, week46, week54 |
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