Combined Immunosuppression for Pediatric Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043870
• Other study ID #: Combined therapy in CD
• Status: Recruiting
• Phase: Phase 4
• Start date: October 10, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Children's Hospital of Fudan University
• Contact: Lin Wang
• Phone: +8613817510412
• Email: wanglin546974055[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children, Only
• Crohn Disease
• Immunosuppression
• Infliximab

Intervention

Drug:
• Infliximab and immunosuppressives
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
the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	infliximab concentration	The infliximab (IFX) concentration and anti-infliximab antibodies (ATI) were measured before the infusion of week 14, 38.	week 14, 38
Other	adverse events	The rate of the potential adverse events were monitored during the intervention.	within one year
Primary	clinical remission	The clinical remission rate at week 54	week 54
Primary	endoscopic remission	The endoscopic remission rate at week 54	week 54
Secondary	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.	week0, week2, week6, week14, week22, week30, week38, week46, week54