Combined Immunosuppression for Pediatric Crohn's Disease
NCT ID: NCT05043870
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
128 participants
INTERVENTIONAL
2022-10-10
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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 therapy
the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks
Infliximab
the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Crohn's Disease-related surgery
3. infections
4. tumors
6 Years
18 Years
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Ying HUANG
Head of department of gastroenterology
Principal Investigators
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Ying Huang
Role: STUDY_DIRECTOR
Children's Hospital of Fudan University
Locations
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Combined therapy in CD
Identifier Type: -
Identifier Source: org_study_id
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