Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01266785
Status:
WITHDRAWN
Last Update Posted:
2019-05-08
First Post:
2010-12-23
Brief Title:
Infliximab Regulatory T Cells IL2 and Crohns Disease
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Analysis of Relationship Between Infliximab Treatment Response Regulatory T Cells and Interleukin-2 in Crohns Disease
Status:
WITHDRAWN
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Crohns disease is an inflammatory swelling and soreness disorder of the digestive tract Affected patients suffer from abdominal pains diarrhea sometimes bloody weight loss It is a lifelong disease with frequent flares during the course of the disease Crohns disease is mostly treated with medications sometimes surgery is needed Infliximab is a medication for treating severe Crohns disease This medicine is effective by blocking special substance tumor necrosis factor released from certain white blood cells in the body Infliximab is given via a vessel at week 0 2 6 initially then every 2 monthly for maintenance However some of patients with Crohns disease do not respond infliximab Currently there is no test to reveal which patients will respond to treatment This study aims to analyze and compare particular subgroup of white cells and its products during and after infliximab treatment which may determine the responsiveness to infliximab treatment
Detailed Description:
All patients will have chest x-ray and pregnancy test if female prior to infliximab treatment
There will be total 5 study visits At each visit body weight will be measured abdominal exam will be performed 2 tablespoonful of blood will be drawn stool will be collected a questionnaire will be completed
There will be total 5 study visits At each visit body weight will be measured abdominal exam will be performed 2 tablespoonful of blood will be drawn stool will be collected a questionnaire will be completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None