Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2027-02-28

Brief Summary

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Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.

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Detailed Description

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This is a prospective, multicenter registry study in Chinese pediatric Crohn's disease patients. A total of 30 subjects were planned to be enrolled and treated with Infliximab. Subjects were observed for 102 weeks after administration to evaluate the clinical efficacy and safety of infliximab in the treatment of children with Crohn's disease in a real diagnostic setting.

Conditions

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Crohn Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Infliximab

Infliximab for the treatment of Crohn's disease in children

Group Type EXPERIMENTAL

Infliximab

Intervention Type DRUG

Infliximab in the treatment of Crohn's disease in children

Interventions

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Infliximab

Infliximab in the treatment of Crohn's disease in children

Intervention Type DRUG

Other Intervention Names

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CMAB008

Eligibility Criteria

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Inclusion Criteria

1. Age ranged 6 to 17 years (both inclusive), no gender limitation.
2. A clear diagnosis was made in children with moderate to severe active stage (PCDAI≥30) Crohn's disease refer to the expert consensus on the diagnosis and treatment of inflammatory bowel disease in children (2019 edition).
3. Patients and/or their guardians must sign ICF, and the research agreement/ICF for data collection and data verification shall comply with local laws and regulations.
4. The patient received infliximab for the first time.

Exclusion Criteria

1. Patients with contraindications to infliximab use (such as severe infection, active tuberculosis, lymphoma or other malignancies), moderate to severe heart failure, and allergies to other murine proteins, infliximab or any component of this product.
2. Those who accept other anti-TNF-α any biological drugs or any other biologicals.
3. Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period
4. Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF
5. The investigator judges the subject inappropriate to be included in this study.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No