Combined Immunosuppression for Pediatric Crohn's Disease
Phase 4 · Testing Infliximab and immunosuppressives and Infliximab · 1 site · Children's Hospital of Fudan University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Infliximab and immunosuppressives (a drug) and Infliximab (a drug) as a possible treatment. Condition(s) listed: Crohn Disease, Infliximab and Immunosuppression.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 6 to 18
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 128 participants are expected to take part.
- Start date: 2022-10-10.
- Main results expected around 2026-10-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- clinical remission (week 54)
In the researchers’ words
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.
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 | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn Disease; Infliximab; Immunosuppression; Children, Only |
| Lead sponsor | Children's Hospital of Fudan University |
| Enrollment | 128 (estimated) |
| Start date | 2022-10-10 |
| Primary completion (est.) | 2026-10-31 |
| First posted | 2021-09-14 |
| Last updated | 2026-03-19 |
| Official title | Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease |
| ClinicalTrials.gov ID | NCT05043870 |
Interventions
- Infliximab and immunosuppressives (Drug)
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 - Infliximab (Drug)
the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks
Full eligibility criteria (from the record)
Inclusion Criteria: 1. 6-18 years old 2. diagnosis of Crohn's Disease 3. Pediatric Crohn's disease Activity Index (PCDAI)>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) >10 before treatment 4. 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 5. The patient or legal guardian sign the informed consent documents Exclusion Criteria: 1. history of biological agents targeting at tumor necrosis factor (TNF) 2. Crohn's Disease-related surgery 3. infections 4. tumors
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai, Shanghai Municipality | China | Recruiting |
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.