NCT05043870RecruitingPhase 4
Combined Immunosuppression for Pediatric Crohn's Disease
Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 2 Sept 2021
- Start date
- 10 Oct 2022
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Children's Hospital of Fudan University
- Diseases
- Crohn's disease
- NCT number
- NCT05043870
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 128
- From 10 Oct 2022 to the primary completion date, 31 Oct 2026
- 1 site 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
- history of biological agents targeting at tumor necrosis factor (TNF)
- Crohn's Disease-related surgery
- infections
Other
- tumors
Who the study is looking for
- 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
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.