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Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab | Experimental | Infliximab for the treatment of Crohn's disease in children |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Infliximab in the treatment of Crohn's disease in children |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate at 14 weeks | Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points | up to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission rate at week 14 and 54 | Clinical remission: PCDAI≤10 | up to 54 weeks |
| Endoscopic response rate at week 14 and 54 | Endoscopic response: SES-CD decreased ≥ 50% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wu Jie | Contact | 18940251108 | licli2860@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Wu Jie | Beijing Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| up to 54 weeks |
| Mucosal healing rate at week 14 and 54 | Mucosal healing: SES-CD 0-2 | 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 | The z-score is converted from anthropometric measurements based on the World Health Organization growth reference. The z-score including: height-for-age z-score (HAZ), weight-for-age z-score (WAZ) and BMI-for-age z-score. | up to 54 weeks |
| Changes from baseline in serum C-reactive protein at week 14 and 54 | Changes from baseline in serum C-reactive protein at week 14 and 54 | up to 54 weeks |
| Changes from baseline in erythrocyte sedimentation rate at week 14 and 54 | Changes from baseline in erythrocyte sedimentation rate at week 14 and 54 | up to 54 weeks |
| Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks | Delayed development: Female children over 13 years old and male children over 14 years old are in the Tanner stage I | up to 54 weeks |
| ADA positive rate | ADA positive rate at week 14 and 54 | up to 54 weeks |
| Percentage of participants with Adverse Events | Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study | up to 102 weeks |
| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |