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A Blood and Tissue Sample Collection Study of Patients Who Have Inflammatory Bowel Disease, Who Have Been Treated With Adalimumab and Who Developed Hepatosplenic T-Cell Lymphoma

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Disease Information

Descriptive Information
Brief Title † A Blood and Tissue Sample Collection Study of Patients Who Have Inflammatory Bowel Disease, Who Have Been Treated With Adalimumab and Who Developed Hepatosplenic T-Cell Lymphoma
Official Title † A Multicenter Study to Collect Samples for Future Evaluation of Biomarkers and Genetic Mutations in Patients Exposed to Adalimumab With Crohn's Disease (CD) or Ulcerative Colitis (UC) Who Developed Hepatosplenic T-Cell Lymphoma (HSTCL)
Brief Summary To collect and store blood and biopsy samples obtained from CD or UC patients exposed to adalimumab and diagnosed with Hepatosplenic T-cell Lymphoma (HSTCL), for the purpose of identifying potential biomarkers and genetic mutations in patients who have developed HSTCL.
Detailed Description A study to bank samples for future evaluation to identify genetic mutations and other biomarkers that predispose inflammatory bowel disease (IBD) patients to developing Hepatosplenic T-cell Lymphoma (HSTCL).
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † Collection of Samples
Secondary Outcome Measure †
Condition † Crohn's Disease Ulcerative Colitis Hepatosplenic T-Cell Lymphoma
Intervention †
Study Arms / Comparison Groups Group 1 To collect and store blood and biopsy samples obtained from CD or UC patients exposed to adalimumab and diagnosed with HSTCL for the purpose of identifying potential biomarkers and genetic mutations in patients who develop HSTCL.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 40
Start Date † March 31, 2014
Completion Date September 30, 2019
Primary Completion Date September 30, 2019
Eligibility Criteria † Inclusion Criteria: - Male or female who has received a single dose of HUMIRA prior to a confirmed diagnosis of HSTCL. - Confirmed diagnosis of CD or UC as documented by a Gastroenterologist or physician who diagnosed the CD or UC. - Confirmed diagnosis of HSTCL as determined by a biopsy performed on a specimen taken from the patient. - Patients 18 years old and older must voluntarily sign and date an IRB/EC approved Informed Consent Form. For patients younger than 18 years old, a parent or legal guardian is required to voluntarily sign and date an IRB/EC approved Informed Consent Form. Pediatric patients will be included in all discussions if possible, in order to obtain their assent. Exclusion Criteria: - Male or female who has not received at least a single dose of adalimumab prior to a confirmed diagnosis of HSTCL. - Unconfirmed diagnosis of HSTCL, CD or UC, respectively. - The patient or the patient's HCP is unwilling to participate in this study. - The parents or legal guardians (in the case of patients younger than 18 years of age), who are unable and/or unwilling to consent to the patient's participation in this study.
Gender All
Ages 1 Year - 99 Years
Accepts Healthy Volunteers No
Contacts †† Andrea L. Byars, BS, +1-847-937-7904, Andrea.Byars@abbvie.com
Location Countries † United States
Administrative Information
NCT ID † NCT02087878
Organization ID F14-258
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † AbbVie
Collaborators ††
Investigators † Study Director: Ezequiel Neimark, MD, AbbVie
Information Provided By
Verification Date April 2017
First Received Date † March 13, 2014
Last Updated Date April 17, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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