E6011-CS1 study

JRCT ID: jRCT1031190056

Registered date:17/07/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Crohn's disease
• Date of first enrollment: 30/09/2019
• Target sample size: 32
• Study type: Interventional

Intervention(s)

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, about 12.5mL per visit.

1.Adalimumab:At the beginning of the study, after that, 2, 4, 12, 24, 52 weeks after or at the termination
2.Infliximab:At the beginning of the study,after that, 2, 6, 14, 22, 54 weeks after or at the termination
3. Ustekinumab:At the beginning of the study,after that, 2, 8, 20, 32, 56weeks after or at the termination

Study2:None.

Outcome(s)

Primary Outcome

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 Outcome: Not defined

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Mikami Yohei
• Secondary Sponsor: EA Pharma Co.,Ltd.