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The purpose of this study is to determine which early infliximab pharmacokinetic level is most associated with clinical remission at weeks 30 and 54 in pediatric IBD patients.
Our aims are:
Subject recruitment is limited to patients of the principal investigator only. Subjects will be approached for participation in the research in person during a routine clinic visit by a member of the study team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention | No intervention- this is an observational study of patients receiving Infliximab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | no intervention- tihs is an observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infliximab level and clinical remission at 54 weeks | Determine what level (peak, 2 week or trough) best correlates with clinical remission at week 54 Clinical remission definition: PCDAI < 10 or CDAI < 150 for Crohn's disease, or partial Mayo <2 points and no sub-score > 1 for ulcerative colitis. Fischer exact testing will be done to determine what detectable IFX level (week 6, week 8 or week 14) is most associated with week 54 clinical remission. Wilcoxon rank sum test will be performed to determine the median level that is most associated with week 54 clinical remission. Regression tree analysis will be performed to determine the optimal infliximab level cut point that predicts week 54 clinical remission. | 54 weeks |
| Infliximab level and clinical remission at 30 weeks | Determine what level (peak, 2 week or trough) best correlates with clinical remission at week 30 Clinical remission definition: PCDAI < 10 or CDAI < 150 for Crohn's disease, or partial Mayo <2 points and no sub-score > 1 for ulcerative colitis. | 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement between pk profiles predicted by the PK model and actual (measured) pk profiles | Secondary outcomes
|
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Inclusion Criteria:
Exclusion Criteria:
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Males and females patients age 6 to 23
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| Name | Affiliation | Role |
|---|---|---|
| Namita Singh, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| 1 year |
| D003092 | Colitis |
| D003108 | Colonic Diseases |