Actively Recruiting
Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease
Led by Children's Hospital of Fudan University · Updated on 2026-03-19
128
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of infliximab alone compared to a combination of infliximab and immunosuppressive therapy in children with Crohn's disease. This randomized controlled trial focuses on pediatric patients aged 6 to 18 years who have moderate to severe disease activity as measured by clinical and endoscopic scores. The study aims to provide important information about treatment options for pediatric Crohn's disease. Participants receive infliximab infusions at 0, 2, and 6 weeks, followed by maintenance doses every 8 weeks. Those in the combination group also take immunomodulatory drugs such as azathioprine daily or methotrexate weekly at specified doses. The trial compares this combined therapy to infliximab alone over time to assess differences in outcomes. During the study, children will undergo regular assessments including clinical remission and endoscopic remission evaluations at week 54. Disease activity will be monitored frequently using the Pediatric Crohn's Disease Activity Index at multiple time points throughout the trial. Safety and treatment response will be carefully observed under medical supervision from the start through the study completion.
CONDITIONS
Brief Title
Combined Immunosuppression for Pediatric Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 18 years old
- Diagnosis of Crohn's Disease
- Pediatric Crohn's Disease Activity Index (PCDAI) greater than 30 or Simple Endoscopic Score for Crohn Disease (SES-CD) greater than 10 before treatment
- Receiving exclusive enteral nutrition or corticosteroids as first-line treatment with PCDAI greater than 10 or SES-CD 3 or higher after treatment
- Patient or legal guardian has signed informed consent documents
You will not qualify if you...
- History of biological agents targeting tumor necrosis factor (TNF)
- History of Crohn's Disease-related surgery
- Current infections
- Presence of tumors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 54 weeks
Participants receive infusions of infliximab (5 mg/kg) at weeks 0, 2, and 6, then every 8 weeks. Some participants also take daily immunosuppressive medication such as azathioprine or weekly methotrexate.
Infusions at weeks 0, 2, 6, and every 8 weeks thereafter with regular assessments at weeks 0, 2, 6, 14, 22, 30, 38, 46, and 54
Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
Research Team
L
Lin Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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