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The primary purpose of the project is to determine what is the best schedule for restarting infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint would be the failure rate; the need to discontinue infliximab or change treatment. A secondary aim will be to determine if infliximab drug and antibody levels can predict clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and long-term steroid free remission rate, and serum and fecal inflammatory markers in response to infliximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab at weeks 0,2, and 6 | Experimental | In this arm subjects will receive re-induction treatment of infliximab at weeks 0,2, and 6. |
|
| Infliximab at weeks 0,4, and 8 | Experimental | In this arm subjects will receive re-induction treatment of infliximab at weeks 0, 4, and 8 |
|
| Infliximab at weeks 0, and 8 | Active Comparator | In this arm subjects will not be randomized. They will receive re-induction therapy weeks 0 and 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab at weeks 0,2, and 6 | Drug |
| ||
| Infliximab at weeks 0,4, and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Failure Rate | Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term clinical response | The physician will determine the presence or absence of IBD (Inflammatory Bowel Disease) using his clinical judgement based on clinical disease indices and serum inflammatory biomarkers. | One year |
| Long-term clinical response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lea Chen | NYU Langone Health | Principal Investigator |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Drug |
|
| Infliximab at weeks 0 and 8 | Drug | For physicians who do not feel comfortable enrolling patients in a randomized trial of infliximab re-induction they will have the option of enrolling their patients in an arm that resumes maintenance therapy only instead at 0 and 8 weeks. |
|
The physician will determine the presence or absence of IBD (Inflammatory Bowel Disease) using his clinical judgement based on clinical disease indices and serum inflammatory biomarkers. |
| One year |
| Short-term changes in patient Quality of Life | This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | One Year |
| Long-term changes in patient Quality of Life | This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | One Year |
| Fecal calprotectin measurements | This will be measured by ELISA kits | One year |