Combined Immunosuppression for Pediatric Crohn's Disease

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05043870

Collaborator

(none)

Enrollment

Arms

36.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease Infliximab Immunosuppression Children, Only	Drug: Infliximab and immunosuppressives Drug: Infliximab	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: infliximab and immunosuppressives therapy the infusion of infliximab (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	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 Other Names: IFX, IMMs, AZA, MTX
Active Comparator: infliximab therapy the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks	Drug: Infliximab the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks Other Names: IFX

Arm

Intervention/Treatment

Experimental: infliximab and immunosuppressives therapy

the infusion of infliximab (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

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

Other Names:

IFX, IMMs, AZA, MTX

Active Comparator: infliximab therapy

the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks

Drug: Infliximab

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

Other Names:

IFX

Outcome Measures

Primary Outcome Measures

clinical remission [week 54]
The clinical remission rate at week 54
endoscopic remission [week 54]
The endoscopic remission rate at week 54

Secondary Outcome Measures

Pediatric Crohn's disease Activity Index score [week0, week2, week6, week14, week22, week30, week38, week46, week54]
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.

Other Outcome Measures

infliximab concentration [week 14, 38]
The infliximab (IFX) concentration and anti-infliximab antibodies (ATI) were measured before the infusion of week 14, 38.
adverse events [within one year]
The rate of the potential adverse events were monitored during the intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

history of biological agents targeting at tumor necrosis factor (TNF)
Crohn's Disease-related surgery
infections
tumors

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Children's Hospital of Fudan University

Investigators

Study Director: Ying Huang, Children's Hospital of Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ying HUANG, Head of department of gastroenterology, Children's Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT05043870

Other Study ID Numbers:

Combined therapy in CD

First Posted:

Sep 14, 2021

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Crohn Disease

Infliximab

Immunosuppressive Agents

Study Results

No Results Posted as of Jun 8, 2022