Inflammatory Bowel Disease
Conditions
Keywords
Influximab, IFX, Remicade
Brief summary
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.
Interventions
DRUGInfliximab at weeks 0,2, and 6
DRUGInfliximab at weeks 0,4, and 8
DRUGInfliximab at weeks 0 and 8
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects 18 years or older who are willing and able to provide informed consent * HIstory of IBD (Crohn's disease, ulcerative colitis, indeterminate colitis) by standard clinical, histological, and radiographic date. * History of stable clinical response to prior IFX induction and regular maintenance dosing, as determine by enrolling clinician. * Prior to drug holiday, was on stable dose of infliximab for at least 3 infusions at regular maintenance intervals * Infliximab drug holiday for at least 12 weeks.
Exclusion criteria
* Inability or unwillingness to provide informed consent * Pregnant patients * Prior history of serious infusion reaction to IFX
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure Rate | One year | Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-term clinical response | One year | 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. |
| Long-term clinical response | One year | 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. |
| Short-term changes in patient Quality of Life | One Year | This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) |
| Long-term changes in patient Quality of Life | One Year | This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) |
| Fecal calprotectin measurements | One year | This will be measured by ELISA kits |
Outcome results
None listed