Crohn DiseasePhase 4NCT05043870
Combined Immunosuppression for Pediatric Crohn's Disease
A Phase 4 study testing Infliximab and immunosuppressives and Infliximab in people with Crohn Disease and Infliximab, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Crohn Disease, Infliximab, Immunosuppression
- What is being tested?
- Infliximab and immunosuppressives and Infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2022to 31 Dec 2026
- Phase
- Phase 4
- 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
- 6-18 years old
- diagnosis of Crohn's Disease
- Pediatric Crohn's disease Activity Index (PCDAI)>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) >10 before treatment
- receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatric Crohn's disease Activity Index (PCDAI)>10 or The Simple Endoscopic Score for Crohn Disease (SES-CD)≥3 after exclusive enteral nutrition or corticosteroids
- The patient or legal guardian sign the informed consent documents
Who cannot join
- history of biological agents targeting at tumor necrosis factor (TNF)
- Crohn's Disease-related surgery
- infections
- tumors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Lin Wang, Doctor, 13817510412, wanglin546974055@163.com
About this study
Official title: Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease
This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.
- Conditions
- Crohn Disease, Infliximab, Immunosuppression, Children, Only
- Being tested
- Infliximab and immunosuppressives, Infliximab
- 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 and immunosuppressivesDrug
Also called IFX, IMMs, AZA, MTX
the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks, the immunomodulatory agent was azathioprine 1-2mg/kg per day or methotrexate 10-25 mg/m2 week
InfliximabDrug
Also called IFX
the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| infliximab and immunosuppressives therapy | Experimental | the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks, the immunomodulatory agent was azathioprine 1-2mg/kg per day or methotrexate 10-25 mg/m2 week Receives: Drug: Infliximab and immunosuppressives |
| infliximab therapy | Active comparator | the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical remission
The clinical remission rate at week 54
Measured: week 54
endoscopic remission
The endoscopic remission rate at week 54
Measured: week 54
Secondary outcomes (1)
Pediatric Crohn's disease Activity Index score
The Pediatric Crohn's disease Activity Index (PCDAI) was assessed at each infusion point. PCDAI score ranges from 0 to 100, the higher means the worse outcome.
Measured: week0, week2, week6, week14, week22, week30, week38, week46, week54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start10 Oct 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying HUANG, Children's Hospital of Fudan University
- Investigators
- Ying Huang, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043870
- Sponsor's protocol ID
- Combined therapy in CD
- Status last verified
- Mar 2026
- First submitted
- 2 Sep 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease
- ClinicalTrials.gov ID
- NCT05043870
- Acronym / sponsor ID
- Combined therapy in CD
- Conditions
- Crohn Disease, Infliximab, Immunosuppression, Children, Only
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Sep 2021 (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.
This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infliximab and immunosuppressives therapy | Experimental | Drug: Infliximab and immunosuppressivesthe infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks, the immunomodulatory agent was azathioprine 1-2mg/kg per day or methotrexate 10-25 mg/m2 week |
| infliximab therapy | Active comparator | Drug: Infliximabthe infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 6-18 years old
- diagnosis of Crohn's Disease
- Pediatric Crohn's disease Activity Index (PCDAI)>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) >10 before treatment
- receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatric Crohn's disease Activity Index (PCDAI)>10 or The Simple Endoscopic Score for Crohn Disease (SES-CD)≥3 after exclusive enteral nutrition or corticosteroids
- The patient or legal guardian sign the informed consent documents
Key exclusion criteria (4 listed)
- history of biological agents targeting at tumor necrosis factor (TNF)
- Crohn's Disease-related surgery
- infections
- tumors
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 and immunosuppressivesAlso: IFX, IMMs, AZA, MTXthe infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks, the immunomodulatory agent was azathioprine 1-2mg/kg per day or methotrexate 10-25 mg/m2 week | Drug | infliximab and immunosuppressives therapy |
| InfliximabAlso: IFXthe infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks | Drug | infliximab therapy |
Primary outcome
clinical remission
Time frame: week 54
The clinical remission rate at week 54
endoscopic remission
Time frame: week 54
The endoscopic remission rate at week 54
1 secondary outcome
Pediatric Crohn's disease Activity Index score
Time frame: week0, week2, week6, week14, week22, week30, week38, week46, week54
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 19 Mar 2026.
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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.
Ying Huang study director
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab and immunosuppressives and Infliximab in people with Crohn Disease and Infliximab, run by Children's Hospital of Fudan University at 1 site 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lin Wang (+8613817510412, wanglin546974055@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical remission (time frame: week 54). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2026.