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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infliximab and immunosuppressives therapy | Experimental | 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 therapy | Active Comparator | the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab and immunosuppressives | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| clinical remission | The clinical remission rate at week 54 | week 54 |
| endoscopic remission | The endoscopic remission rate at week 54 | week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week0, week2, week6, week14, week22, week30, week38, week46, week54 |
| Measure | Description | Time Frame |
|---|---|---|
| infliximab concentration | The infliximab (IFX) concentration and anti-infliximab antibodies (ATI) were measured before the infusion of week 14, 38. | week 14, 38 |
| adverse events | The rate of the potential adverse events were monitored during the intervention. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Wang | Contact | +8613817510412 | wanglin546974055@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Huang | Children's Hospital of Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 201102 | 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 |
| D007166 | Immunosuppressive Agents |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| Infliximab | Drug | the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks |
|
|
| within one year |
| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |