The Efficacy and Safety of Infliximab Combination With Azathioprine in Crohn's Disease in Children
Not applicable · Testing Infliximab combined with azathioprine therapy and Infliximab monotherapy · 4 sites · The Children's Hospital of Zhejiang University School of Medicine
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Infliximab combined with azathioprine therapy (a drug) and Infliximab monotherapy (a drug) as a possible treatment. Condition(s) listed: Crohn's Diseases and Crohn's Disease in Pediatric Patient.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 6 to 18
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 1 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 154 participants are expected to take part.
- Start date: 2026-03-01 (planned).
- Main results expected around 2028-11-30 (estimate from the record).
- 4 study sites listed in China.
Main thing being measured
- The clinical remission rates（(Pediatric Crohn's Disease Activity Index）in the 14th week and the 54th week (the 14th week and the 54th week)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Diseases; Crohn's Disease in Pediatric Patient |
| Lead sponsor | The Children's Hospital of Zhejiang University School of Medicine |
| Collaborators | Second Affiliated Hospital of Wenzhou Medical University; The First People's Hospital of Yunnan |
| Enrollment | 154 (estimated) |
| Start date | 2026-03-01 |
| Primary completion (est.) | 2028-11-30 |
| First posted | 2026-02-20 |
| Last updated | 2026-02-20 |
| Official title | Study on the Efficacy and Safety of Infliximab Monotherapy or in Combination With Azathioprine in the Treatment of Crohn's Disease in Children |
| ClinicalTrials.gov ID | NCT07424040 |
Interventions
- Infliximab combined with azathioprine therapy (Drug)
Infliximab 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 (Drug)
Infliximab is administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Criteria: * 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
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| The First People's Hospital of Yunnan | Kunming, Yunnan | China | |
| The Children's Hospital of Zhejiang University School of Medicine | Hangzhou, Zhejiang | China | |
| JinHua Maternal & Child Health Care Hospital | Jinhua, Zhejiang | China | |
| Second Affiliated Hospital of Wenzhou Medical University | Wenzhou, Zhejiang | China |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.