Procurement of blood samples from subjects with diagnosed inflammatory bowel disease for use in the development of Anser® vedolizumab test (161BD04)

HS 2016-2923
Inflammatory Bowel Disease, Crohn’s disease, Ulcerative colitis
Nimisha Parekh, MD
Gottschalk Medical Center, Irvine/Hewitt Hall
The primary objective of this study is to obtain well-characterized blood specimens from subjects with a clinical diagnosis of inflammatory bowel disease (IBD) treated with vedolizumab (VDZ), presenting with initial failure to respond or loss of response to treatment or intolerance to VDZ. The purpose of this study is to enable analytical validation of the Anser® VDZ test, design to measure serum levels of VDZ and antibodies to VDZ (ATV).

Inclusion criteria:

  • Male and female subjects must be at least 18 years of age.
  • The subject must have a confirmed diagnosis of IBD based on results of a complete medical evaluation and the assessment by a physician specialized in IBD. The IBD will be categorized as either Crohn's disease (CD) or ulcerative colitis (UC).  
  • Subjects either previously were or currently are on VDZ treatment, experiencing primary treatment failure or secondary loss of response or intolerance to VDZ treatment.
  • Subjects understand the procedures and requirements of the study by providing written informed consent or including consent and authorization for protected health information disclosure.

Exclusion criteria:

You cannot participate in this study if you have received an blood products within three (3) months prior to study entry.

This study includes two (2) visits and takes about two (2) hours.
You will not directly benefit from participation in this study and it will not impact your clinical care and management. If the research is successful in developing a test for monitoring vedolizumab treatment, there may be benefit to future subjects prescribed vedolizumab for monitoring of therapy efficacy for optimization of treatment.
You will be paid $50 after each blood draw. There will be no more than two (2) blood draws.
Other
vedolizumab
Douglas O'Connell, MS
714-456-7033