Infliximab alone or with azathioprine for children with Crohn's disease
Compares infliximab with and without azathioprine in children with Crohn's disease.
Plain-language title generated from the registry record
Registry title: The Efficacy and Safety of Infliximab Combination With Azathioprine in Crohn's Disease in Children
Key facts
- Where
- Hangzhou, Jinhua, Kunming, and Wenzhou, ChinaSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 18 years old?
Source: NCT07424040, who can take part
Where in China
- The Children's Hospital of Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
- JinHua Maternal & Child Health Care HospitalJinhua, ChinaNo longer taking part
- The First People's Hospital of YunnanKunming, ChinaNo longer taking part
- Second Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Children's Hospital of Zhejiang University School of Medicine
- Trial code
- NCT07424040
- Record updated
- 20 February 2026
- Original description
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:Read full original descriptionShow less
Study on the Efficacy and Safety of Infliximab Monotherapy or in Combination With Azathioprine in the Treatment of Crohn's Disease in Children
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.
Inclusion: 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.
Exclusion: 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; Homozygous mutations in NUDT15 or TPMT genes, or heterozygous mutations in at least one of the above genes.