Combining treatments for children with Crohn's disease
Official title: Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease
Run by Children's Hospital of Fudan University · NCT05043870 · Data updated 2026-11-12
This study is testing whether combining two treatments for Crohn's disease can help children feel better compared to using just one of the treatments alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Drugs / interventions | infliximab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | October 10, 2022 |
| Main results expected | October 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT05043870 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6 to 18 years with a confirmed diagnosis of Crohn's disease and specific disease activity scores indicating moderate to severe disease.
✕Probably not a fit
Patients with a history of biological treatments targeting TNF, Crohn's-related surgeries, infections, or tumors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of infliximab combined with immunosuppressive therapy compared to either treatment alone in children diagnosed with Crohn's disease. It involves a randomized controlled design where participants aged 6 to 18 years will be assessed based on specific disease activity scores before and after treatment. The study seeks to determine the optimal therapeutic approach for managing pediatric Crohn's disease.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for children suffering from Crohn's disease.
How similar studies have gone: Other studies have shown promise in using combined immunosuppressive therapies for similar conditions, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Lin Wang
- Email: wanglin546974055@163.com
- Phone: +8613817510412
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Infliximab treatment for Crohn's disease with drug monitoring
This study is testing if adjusting infliximab treatment based on drug levels helps people with active perianal fistulizing Crohn's disease feel better compared to standard fixed dosing.
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Examining the link between polyamine levels and inflammatory bowel disease progression
This study is trying to see if measuring certain substances in the body can help predict how inflammatory bowel diseases like Ulcerative Colitis and Crohn's Disease will progress in patients.
-
Switching to subcutaneous infliximab for IBD treatment
This study is testing if switching people with inflammatory bowel disease from an intravenous form of infliximab to a subcutaneous version, given weekly or bi-weekly, can lead to better health results.
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Registry of Infliximab for Children with Crohn's Disease in China
This study is testing how well Infliximab works and how safe it is for children aged 6 to 17 with moderate to severe Crohn's disease in China.
-
Personalized infliximab dosing for Crohn's disease treatment
This study is testing whether a computer program that customizes infliximab doses based on blood tests can help people with Crohn's disease feel better compared to the usual dosing methods.
-
Comparing two treatment approaches for children with ulcerative colitis
This study is testing whether a new medicine called infliximab works better than traditional steroids for children with moderate to severe ulcerative colitis to help them feel better and heal faster.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.