Crohn's DiseasesNCT07424040
The Efficacy and Safety of Infliximab Combination With Azathioprine in Crohn's Disease in Children
A study testing Infliximab combined with azathioprine therapy and Infliximab monotherapy in people with Crohn's Diseases and Crohn's Disease in Pediatric Patient, run by The Children's Hospital of Zhejiang University School of Medicine at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Crohn's Diseases, Crohn's Disease in Pediatric Patient
- What is being tested?
- Infliximab combined with azathioprine therapy and Infliximab monotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 4 sitesChina
- Study dates
- 1 Mar 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Youyou Luo, 13867467021, looloohi@zju.edu.cn
JinHua Maternal & Child Health Care Hospital
Jinhua, Zhejiang, 321000
Paijian Lai, 13665883260, 13665883260@163.com
The First People's Hospital of Yunnan
Kunming, Yunnan, 650000
Yunfen Tian, 13769112828, 136506595@qq.com
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Shuzi Zheng, 18857704481, 15869126891@163.com
About this study
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
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.
Read more
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.
Read the detailed description
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD). In recent years, the incidence of CD in children has shown a significant upward trend globally, and it has also increased significantly in Chinese children. According to epidemiological studies, the incidence of CD in Chinese children is approximately 2.5 to 11 cases per 100,000 people per year. CD in children is usually more severe and can significantly affect the psychological and social functions as well as physical development of patients. Infliximab (IFX), as the first tumor necrosis factor-α (TNF-α) antagonist approved for the treatment of CD, specifically binds and neutralizes TNF-α, inhibiting intestinal inflammatory responses and promoting mucosal healing. In the field of pediatric CD, several studies have preliminarily confirmed that IFX monotherapy can effectively induce clinical remission, promote growth and development, and reduce hormone dependence. However, a considerable proportion (37.8% to 43.3%) of CD patients treated with anti-TNF-α therapy will develop secondary adaptive responses (LOR). Therefore, they need dose intensification, switching to other anti-TNF drugs, or switching to drugs with different mechanisms of action for intervention. Multiple studies have shown that the combination of anti-TNF-α drugs with immunomodulators may reduce the production of anti-drug antibodies and improve efficacy, thereby maintaining remission. The most commonly used immunomodulators for IBD are thiopurine drugs, such as azathioprine or 6-mercaptopurine. Some previous studies suggest that combination therapy may be superior to monotherapy in adult CD, but its efficacy and safety for this special group of children remain controversial: on the one hand, the immune system of children is not yet fully developed, and combined therapy may further increase the risks of infection and bone marrow suppression; on the other hand, children have urgent needs for growth and development, and the effectiveness and safety of combined therapy in improving growth retardation and promoting mucosal healing still require more high-quality evidence to support. Currently, there are limited clinical studies on the use of IFX monotherapy or IFX combined with azathioprine for pediatric CD in both domestic and international settings, and most of them are small-sample retrospective studies, lacking large-sample prospective randomized controlled trial (RCT) data. At the same time, there is also a lack of evidence on the optimal timing of combined therapy, dose adjustment strategies, and long-term follow-up safety (such as long-term tumor risk, fertility impact, etc.) for combined therapy, which cannot provide sufficient evidence for clinical decision-making. Based on the above background, this study aims to compare the efficacy and safety of IFX monotherapy and IFX combined with azathioprine in treating pediatric CD, in order to clarify the differences in efficacy of the two treatment regimens in inducing remission, maintaining remission, mucosal healing, and growth and development of pediatric CD, and to comprehensively analyze their short-term and long-term safety characteristics, in order to provide more reliable evidence-based medical evidence for individualized treatment of pediatric CD, optimize clinical treatment pathways, and ultimately improve the long-term prognosis and quality of life of children.
- Being tested
- Infliximab combined with azathioprine therapy, Infliximab monotherapy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab combined with azathioprine therapyDrug
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 monotherapyDrug
Infliximab is administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy | Experimental | 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. Receives: Drug: Infliximab combined with azathioprine therapy |
| Monotherapy | Active comparator | Infliximab is administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter. Receives: Drug: Infliximab monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the 14th week and the 54th week
Secondary outcomes (3)
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。
Measured: within 54 weeks
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.
Measured: the 14th week and the 54th week
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.
Measured: the 14th week and the 54th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseasesStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Wenzhou Medical University, The First People's Hospital of Yunnan
- Responsible party
- Principal investigator, Youyou Luo, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424040
- Sponsor's protocol ID
- CHZJU2025IIT017
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kappelman MD, Wohl DA, Herfarth HH, Firestine AM, Adler J, Ammoury RF, Aronow JE, Bass DM, Bass JA, Benkov K, Tobi CB, Boccieri ME, Boyle BM, Brinkman WB, Cabera JM, Chun K, Colletti RB, Dodds CM, Dorsey JM, Ebach DR, Entrena E, Forrest CB, Galanko JA, Grunow JE, Gulati AS, Ivanova A, Jester TW, Kaplan JL, Kugathasan S, Kusek ME, Leibowitz IH, Linville TM, Lipstein EA, Margolis PA, Minar P, Molle-Rios Z, Moses J, Olano KK, Osaba L, Palomo PJ, Pappa H, Park KT, Pashankar DS, Pitch L, Robinson M, Samson CM, Sandberg KC, Schuchard JR, Seid M, Shelly KA, Steiner SJ, Strople JA, Sullivan JS, Tung J, Wali P, Zikry M, Weinberger M, Saeed SA, Bousvaros A. Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn's Disease: A Pragmatic Randomized Trial. Gastroenterology. 2023 Jul;165(1):149-161.e7. doi: 10.1053/j.gastro.2023.03.224. Epub 2023 Mar 31.
PubMed 37004887
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- CHZJU2025IIT017
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Wenzhou Medical University, The First People's Hospital of Yunnan
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD). In recent years, the incidence of CD in children has shown a significant upward trend globally, and it has also increased significantly in Chinese children. According to epidemiological studies, the incidence of CD in Chinese children is approximately 2.5 to 11 cases per 100,000 people per year. CD in children is usually more severe and can significantly affect the psychological and social functions as well as physical development of patients. Infliximab (IFX), as the first tumor necrosis factor-α (TNF-α) antagonist approved for the treatment of CD, specifically binds and neutralizes TNF-α, inhibiting intestinal inflammatory responses and promoting mucosal healing. In the field of pediatric CD, several studies have preliminarily confirmed that IFX monotherapy can effectively induce clinical remission, promote growth and development, and reduce hormone dependence. However, a considerable proportion (37.8% to 43.3%) of CD patients treated with anti-TNF-α therapy will develop secondary adaptive responses (LOR). Therefore, they need dose intensification, switching to other anti-TNF drugs, or switching to drugs with different mechanisms of action for intervention. Multiple studies have shown that the combination of anti-TNF-α drugs with immunomodulators may reduce the production of anti-drug antibodies and improve efficacy, thereby maintaining remission. The most commonly used immunomodulators for IBD are thiopurine drugs, such as azathioprine or 6-mercaptopurine. Some previous studies suggest that combination therapy may be superior to monotherapy in adult CD, but its efficacy and safety for this special group of children remain controversial: on the one hand, the immune system of children is not yet fully developed, and combined therapy may further increase the risks of infection and bone marrow suppression; on the other hand, children have urgent needs for growth and development, and the effectiveness and safety of combined therapy in improving growth retardation and promoting mucosal healing still require more high-quality evidence to support. Currently, there are limited clinical studies on the use of IFX monotherapy or IFX combined with azathioprine for pediatric CD in both domestic and international settings, and most of them are small-sample retrospective studies, lacking large-sample prospective randomized controlled trial (RCT) data. At the same time, there is also a lack of evidence on the optimal timing of combined therapy, dose adjustment strategies, and long-term follow-up safety (such as long-term tumor risk, fertility impact, etc.) for combined therapy, which cannot provide sufficient evidence for clinical decision-making. Based on the above background, this study aims to compare the efficacy and safety of IFX monotherapy and IFX combined with azathioprine in treating pediatric CD, in order to clarify the differences in efficacy of the two treatment regimens in inducing remission, maintaining remission, mucosal healing, and growth and development of pediatric CD, and to comprehensively analyze their short-term and long-term safety characteristics, in order to provide more reliable evidence-based medical evidence for individualized treatment of pediatric CD, optimize clinical treatment pathways, and ultimately improve the long-term prognosis and quality of life of children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy | Experimental | Drug: Infliximab combined with azathioprine therapyInfliximab 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. |
| Monotherapy | Active comparator | Drug: Infliximab monotherapyInfliximab is administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infliximab combined with azathioprine therapyInfliximab 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. | Drug | Combination therapy |
| Infliximab monotherapyInfliximab is administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter. | Drug | Monotherapy |
Primary outcome
The clinical remission rates（(Pediatric Crohn's Disease Activity Index）in the 14th week and the 54th week
Time frame: 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.
3 secondary outcomes
Comparison of adverse reactions between the two treatment regimens within 54 weeks
Time frame: within 54 weeks
The mucosal healing rates （Simple Endoscopic Score for Crohn's Disease）in the 14th week and the 54th week
Time frame: the 14th week and the 54th week
Patient-reported outcomes（PRO2） for the 14th week and the 54th week
Time frame: the 14th week and the 54th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 37004887Kappelman MD, Wohl DA, Herfarth HH, Firestine AM, Adler J, Ammoury RF, Aronow JE, Bass DM, Bass JA, Benkov K, Tobi CB, Boccieri ME, Boyle BM, Brinkman WB, Cabera JM, Chun K, Colletti RB, Dodds CM, Dorsey JM, Ebach DR, Entrena E, Forrest CB, Galanko JA, Grunow JE, Gulati AS, Ivanova A, Jester TW, Kaplan JL, Kugathasan S, Kusek ME, Leibowitz IH, Linville TM, Lipstein EA, Margolis PA, Minar P, Molle-Rios Z, Moses J, Olano KK, Osaba L, Palomo PJ, Pappa H, Park KT, Pashankar DS, Pitch L, Robinson M, Samson CM, Sandberg KC, Schuchard JR, Seid M, Shelly KA, Steiner SJ, Strople JA, Sullivan JS, Tung J, Wali P, Zikry M, Weinberger M, Saeed SA, Bousvaros A. Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn's Disease: A Pragmatic Randomized Trial. Gastroenterology. 2023 Jul;165(1):149-161.e7. doi: 10.1053/j.gastro.2023.03.224. Epub 2023 Mar 31.
- Website links of the referencesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infliximab combined with azathioprine therapy and Infliximab monotherapy in people with Crohn's Diseases and Crohn's Disease in Pediatric Patient, run by The Children's Hospital of Zhejiang University School of Medicine at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youyou Luo (13867467021, looloohi@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical remission rates（(Pediatric Crohn's Disease Activity Index）in the 14th week and the 54th week (time frame: the 14th week and the 54th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07424040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.