NCT07424040

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Nov 2028

First Submitted

Initial submission to the registry

February 7, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

February 7, 2026

Last Update Submit

February 15, 2026

Conditions

Crohn's DiseasesCrohn's Disease in Pediatric Patient

Outcome Measures

Primary Outcomes (1)

  • 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.

    the 14th week and the 54th week

Secondary Outcomes (3)

  • Comparison of adverse reactions between the two treatment regimens within 54 weeks

    within 54 weeks

  • The mucosal healing rates （Simple Endoscopic Score for Crohn's Disease）in the 14th week and the 54th week

    the 14th week and the 54th week

  • Patient-reported outcomes（PRO2） for the 14th week and the 54th week

    the 14th week and the 54th week

Study Arms (2)

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.

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.

Drug: Infliximab monotherapy

Interventions

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.

Combination therapy
Infliximab monotherapyDRUG

Infliximab is administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter.

Monotherapy

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The First People's Hospital of Yunnan

Kunming, Yunnan, 650000, China

Location

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

JinHua Maternal & Child Health Care Hospital

Jinhua, Zhejiang, 321000, China

Location

Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (1)

  • 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.

    PMID: 37004887BACKGROUND

Related Links

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Youyou Luo

CONTACT

13867467021looloohi@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 20, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)