Combining treatments for children with Crohn's disease
Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease
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 |
| Enrollment | 128 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Drugs / interventions | infliximab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05043870 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using combined immunosuppressive therapies for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Lin Wang
- Email: wanglin546974055@163.com
- Phone: +8613817510412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.