Infliximab, Regulatory T Cells, IL2 and Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT01266785|
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : December 24, 2010
Last Update Posted : May 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: Infliximab||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Analysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's Disease|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||July 2012|
- Drug: Infliximab
Patient will receive Infliximab infusions during Weeks 0, 2 and 6. Therefore, the duration of the Infliximab treatment will last 6 weeks.
- Changes of IL-2 and Treg cell levels [ Time Frame: 1 year ]To determine if the change of IL-2 and Treg cell levels can be used clinically as a predictive marker for differentiating Infliximab responders from nonresponders
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266785
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Zili Zhange, MD, PhD||Oregon Health and Science University|