E6011-CS1 study

Research for medicinal predictive marker on Crohn's disease - E6011-CS1 study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031190056

Enrollment

Registered

2019-07-17

Start date

2019-09-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease Crohn's disease

Interventions

Study1:Evaluate the disease activity and collect the blood according to the schedule as below. Amount of blood collection should be about 15mL at screening test, after the beginning of the study, abou

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Not defined	—

Contacts

Public ContactYukimi Kokubun

RPM Co., Ltd.

y-kokubun@rpmedical.co.jp+81-3-5325-5821

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026