NCT07424040Not yet recruiting
The Efficacy and Safety of Infliximab Combination With Azathioprine in Crohn's Disease in Children
Study on the Efficacy and Safety of Infliximab Monotherapy or in Combination With Azathioprine in the Treatment of Crohn's Disease in Children
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 154 (estimated)
- First submitted
- 7 Feb 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- Diseases
- Crohn's disease
- NCT number
- NCT07424040
What you commit to
- Study type: Interventional
- Planned participants: 154
- From 1 Mar 2026 to the primary completion date, 30 Nov 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Homozygous mutations in NUDT15 or TPMT genes, or heterozygous mutations in at least one of the above genes
Who the study is looking for
- 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.
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Children's Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| JinHua Maternal & Child Health Care Hospital Coordinator of this site? Confirm its status | Jinhua | China | Unknown status |
| The First People's Hospital of Yunnan Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Second Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.