search
Back to results

Combined Immunosuppression for Pediatric Crohn's Disease

Primary Purpose

Crohn Disease, Infliximab, Immunosuppression

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Infliximab and immunosuppressives
Infliximab
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

infliximab and immunosuppressives therapy

infliximab therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 2, 2021
Last Updated
September 20, 2023
Sponsor
Children's Hospital of Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT05043870
Brief Title
Combined Immunosuppression for Pediatric Crohn's Disease
Official Title
Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Infliximab, Immunosuppression, Children, Only

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
infliximab and immunosuppressives therapy
Arm Type
Experimental
Arm Description
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
Arm Title
infliximab therapy
Arm Type
Active Comparator
Arm Description
the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks
Intervention Type
Drug
Intervention Name(s)
Infliximab and immunosuppressives
Other Intervention Name(s)
IFX, IMMs, AZA, MTX
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Infliximab
Other Intervention Name(s)
IFX
Intervention Description
the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks
Primary Outcome Measure Information:
Title
clinical remission
Description
The clinical remission rate at week 54
Time Frame
week 54
Title
endoscopic remission
Description
The endoscopic remission rate at week 54
Time Frame
week 54
Secondary Outcome Measure Information:
Title
Pediatric Crohn's disease Activity Index score
Description
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.
Time Frame
week0, week2, week6, week14, week22, week30, week38, week46, week54
Other Pre-specified Outcome Measures:
Title
infliximab concentration
Description
The infliximab (IFX) concentration and anti-infliximab antibodies (ATI) were measured before the infusion of week 14, 38.
Time Frame
week 14, 38
Title
adverse events
Description
The rate of the potential adverse events were monitored during the intervention.
Time Frame
within one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 The patient or legal guardian sign the informed consent documents Exclusion Criteria: history of biological agents targeting at tumor necrosis factor (TNF) Crohn's Disease-related surgery infections tumors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Wang
Phone
+8613817510412
Email
wanglin546974055@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Huang
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Wang, Doctor
Phone
13817510412
Email
wanglin546974055@163.com

12. IPD Sharing Statement

Learn more about this trial

Combined Immunosuppression for Pediatric Crohn's Disease

We'll reach out to this number within 24 hrs