The goal of this clinical trial is to investigate whether there are significant differences in the efficacy of infliximab monotherapy and combined azathioprine therapy in treating pediatric Crohn's disease, as well as whether there are differences in the safety of these two treatment regimens during long-term use. The main questions it aims to answer are:
Is infliximab combined with azathioprine superior to monotherapy in inducing and maintaining remission of Crohn's disease in children? In long-term treatment, can infliximab combined with azathioprine more effectively reduce disease activity and the occurrence of complications, but the incidence of adverse reactions is not higher than that of monotherapy? Researchers will compare the treatment of infliximab combined with azioprine with that of infliximab monotherapy to assess the efficacy and safety of both in inducing and maintaining remission of Crohn's disease in children.
Participants will:
Take drug ABC or a placebo every day for 4 months Experimental group: Infliximab, administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter, along with azathioprine, taken orally at 1.5-2.5mg/kg daily.
Control group: Infliximab (Remicade), administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter.
A comprehensive disease assessment will be conducted at the hospital in the 14th and 54th weeks.
Record their symptoms, signs and test results.
Diagnose Crohn's disease based on the 2019 Expert Consensus for the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease.
The baseline Pediatric Crohn's Disease Activity Index (PCDAI) value is ≥ 30.
None of the patients had received treatment with azathioprine, 6-mercaptopurine, or anti-TNF biological agents before.
Patients who received the following adjunctive treatments also meet the participation criteria: acid-suppressing drugs (if the dose was stable for at least 2 weeks before enrollment, it is applicable), enteral nutrition (with a stable plan for 2 weeks). Rectal, intravenous, or oral corticosteroids are not allowed, and they must be discontinued at least 2 weeks before enrollment.
Suffering from short bowel syndrome, ostomy surgery, symptomatic stenosis, abscess, or a recent history of abdominal surgery (within 6 months)
History of tuberculosis or other granulomatous infections, positive chest imaging or positive tuberculin skin test
Recent opportunistic infection history (within 6 months), active hepatitis B or C infection, human immunodeficiency virus infection
Multiple sclerosis, cancer
Parallel
Infliximab combined with azathioprine therapy
DrugInfliximab is administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter. Simultaneously, azathioprine is taken orally at 1.5 - 2.5mg/kg daily.
Infliximab monotherapy
DrugInfliximab is administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter.
The clinical remission rates（(Pediatric Crohn's Disease Activity Index）in the 14th week and the 54th week
The clinical remission rateS of the children was evaluated using the PCDAI (Pediatric Crohn's Disease Activity Index). PCDAI\<10 was considered as clinical remission.
Comparison of adverse reactions between the two treatment regimens within 54 weeks
Adverse reactions include infections, tumors, liver and kidney function impairments, myocardial damage, and bone marrow transplantation, etc Compare the incidence rates of adverse reactions between the two groups。
The mucosal healing rates （Simple Endoscopic Score for Crohn's Disease）in the 14th week and the 54th week
The SES-CD（Simple Endoscopic Score for Crohn's Disease）obtained under colonoscopy was used to evaluate the condition of mucosal healing. SES-CD\<3 was defined as mucosal healing.
Patient-reported outcomes（PRO2） for the 14th week and the 54th week
The patient-reported outcomes for Crohn's disease use standardized assessment tools, namely the PRO2 scale, which includes two core symptoms: "abdominal pain" and "frequency of defecation". The minimum and maximum values of the PRO2 scale are 0 and above 30 respectively. Higher scores mean a worse outcome.
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The Children's Hospital of Zhejiang University School of Medicine
Lead sponsor
Second Affiliated Hospital of Wenzhou Medical University
Collaborator
The First People's Hospital of Yunnan
Collaborator
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