Managing Infliximab Reinduction After Temporary Discontinuation of Drug

Study Overview
=================
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.

Official Title
-----------------
Managing Infliximab Reinduction After Temporary Discontinuation of Drug

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Drug: Infliximab at weeks 0,2, and 6
* Drug: Infliximab at weeks 0,4, and 8
* Drug: Infliximab at weeks 0 and 8


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infliximab at weeks 0,2, and 6<br>In this arm subjects will receive re-induction treatment of infliximab at weeks 0,2, and 6. | Drug: Infliximab at weeks 0,2, and 6<br> <br> |
| Experimental: Infliximab at weeks 0,4, and 8<br>In this arm subjects will receive re-induction treatment of infliximab at weeks 0, 4, and 8 | Drug: Infliximab at weeks 0,4, and 8<br> <br> |
| Active Comparator: Infliximab at weeks 0, and 8<br>In this arm subjects will not be randomized. They will receive re-induction therapy weeks 0 and 8. | Drug: Infliximab at weeks 0 and 8<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure Rate | Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab. | One year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influximab, IFX, Remicade