Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Infliximab.
- Who it may be relevant to
- Registry conditions: Crohn Disease. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
Detailed description
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.
Interventions
- Drug Infliximab
Infliximab in the treatment of Crohn's disease in children
Primary outcome measures
- Clinical response rate at 14 weeks [Time frame: up to 14 weeks]
Secondary outcome measures (9)
- Clinical remission rate at week 14 and 54 [Time frame: up to 54 weeks]
- Endoscopic response rate at week 14 and 54 [Time frame: up to 54 weeks]
- Mucosal healing rate at week 14 and 54 [Time frame: up to 54 weeks]
- Changes from baseline in height-for-age z-score (HAZ), weight-for-age z-score (WAZ) and BMI-for-age z-score at week 14 and 54 [Time frame: up to 54 weeks]
- Changes from baseline in serum C-reactive protein at week 14 and 54 [Time frame: up to 54 weeks]
- Changes from baseline in erythrocyte sedimentation rate at week 14 and 54 [Time frame: up to 54 weeks]
- Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks [Time frame: up to 54 weeks]
- ADA positive rate [Time frame: up to 54 weeks]
- Percentage of participants with Adverse Events [Time frame: up to 102 weeks]
Eligibility criteria
Inclusion criteria
- Age ranged 6 to 17 years (both inclusive), no gender limitation.
- 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).
- 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.
- The patient received infliximab for the first time.
Exclusion criteria
- 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.
- Those who accept other anti-TNF-α any biological drugs or any other biologicals.
- Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period
- Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF
- The investigator judges the subject inappropriate to be included in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Children's Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT05906576 · C008CDIV