E6011-CS1 study

Not Applicable

• Conditions: Crohn's disease; D003424

• Registration Number: JPRN-jRCT1031190056
• Lead Sponsor: Mikami Yohei

Brief Summary

In Crohn's disease patients treated with anti-TNF and anti-IL-12/23p40 agents, CD16+ monocytes/monocytes [FCM] correlated better than CRP for predicting drug response during the treatment induction phase. (endpoint 1) and CRP correlated better at 1 year (endpoint 2). The AUC in ROC analysis for predicting drug efficacy for endpoint 1 and 2 ranged from 0.482 to 0.750. DNA methylation analysis using the loci may be an alternative method to FCM for measuring CD16+ monocytes/monocytes.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-17
• Study Completion: 2022-04-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

(1)Patients aged 16 or older when the written agreements made.(Need agreement for deputy for patients under 20 years old)
(2)Patients diagnosed as definitive Crohn's disease according to the Policy Research business for Health and Labor Sciences Research Grant for Intractable diseases and etc. [ Diagnostic criteria and treatment policy for Crohn's disease, Ulcerative colitis](revised in 2017)
(3)Active Crohn's disease.(only Study1)
(4)The patients who are indicated of Biologics(adalimumab,infliximab,ustekinumab) treatment on Crohn's disease.(only Study1)
(5)Patients who voluntarily provided written informed consent to participate in the study.
(6)Patients who are fully explained about the rules of this research and have the will and ability to abide by them.

Exclusion Criteria

(1)Patients with history of following intestinal surgery, or patients who are scheduled for following intestinal surgery.
Enterectomy within 12 weeks prior to the beginning of the study, stoma or ileal pouch. (except rectostomy)
(2)Patients who have received cytapheresis (granulocyte apheresis/granulocyte monocyte apheresis[GCAP/GMA], leukocytopheresis[LCAP]) within 2 weeks prior to the beginning of the study.
(3)Patients who tested positive for the following viruses in screening test.
HBV, HCV, HIV and HTLV-1

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Because this study is the exploratory study, the primary outcomes and the secondary outcomes are not defined, but, the following outcomes should be evaluated.<br><br>1.Immune cell fractionation (ratio)<br>2.Correlation between flow cytometry and DNA methylation analysis

Secondary Outcome Measures

Name	Time	Method
ot defined