Unique ID issued by UMIN | UMIN000042540 |
---|---|
Receipt number | R000048559 |
Scientific Title | Prospective study of predictors of mucosal healing in anti-TNF-alpha antibody treatment for inflammatory bowel disease |
Date of disclosure of the study information | 2020/12/01 |
Last modified on | 2020/11/24 23:16:47 |
Prospective study of predictors of mucosal healing in anti-TNF-alpha antibody treatment for inflammatory bowel disease
Prospective study of predictors of mucosal healing in anti-TNF-alpha antibody treatment for inflammatory bowel disease
Prospective study of predictors of mucosal healing in anti-TNF-alpha antibody treatment for inflammatory bowel disease
Prospective study of predictors of mucosal healing in anti-TNF-alpha antibody treatment for inflammatory bowel disease
Japan |
Crohn's disease, Ulcerative colitis
Gastroenterology |
Others
NO
The purpose of this study is to measure the blood trough level, cytokines, and inflammatory proteins of patients who have been introduced or maintained with anti-TNF-alpha antibody for inflammatory bowel disease, and evaluate the relationship with mucosal healing.
Efficacy
Association with mucosal healing 54 weeks (newly introduced cases) or 56 weeks (maintenance administration cases) after the start of the study (identification of mucosal healing predictors)
Observational
Not applicable |
Not applicable |
Male and Female
Patients who have been diagnosed with Crohn's disease or ulcerative colitis and are receiving or will be receiving anti-TNF-alpha antibody(infliximab or adalimumab) at Fukuoka University Hospital
1) Patients with serious infections
2) Patients with malignant tumors
3) Patients with severe intestinal stricture, short bowel syndrome, stoma
4) Patients who do not consent to the study
5) Patients who are judged not suitable for this trial by the doctor
300
1st name | So |
Middle name | |
Last name | Imakiire |
Fukuoka University School of Medicine
Gastroenterology
814-0180
7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
092-801-1011
imaso0623@gmail.com
1st name | So |
Middle name | |
Last name | Imakiire |
Fukuoka University School of Medicine
Gastroenterology
814-0180
7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
092-801-1011
imaso0623@gmail.com
Fukuoka University
Fukuoka University
Other
Fukuoka University Hospital
7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
092-801-1011
rinshou@adm.fukuoka-u.ac.jp
NO
2020 | Year | 12 | Month | 01 | Day |
Unpublished
Open public recruiting
2020 | Year | 11 | Month | 04 | Day |
2020 | Year | 11 | Month | 04 | Day |
2020 | Year | 11 | Month | 04 | Day |
2024 | Year | 03 | Month | 31 | Day |
Colonoscopy will be performed to evaluate SES-CD for Crohn's disease and Mayo score and UCEIS for ulcerative colitis. In addition, IFX/ADA blood concentration, cytokines such as TNF-alpha, IFN-gamma, IL-6, IL-17, TGF-beta in blood and colon tissue, oncostatin M, LRG, fecal calprotectin will be measured to evaluate its association with mucosal healing.
2020 | Year | 11 | Month | 24 | Day |
2020 | Year | 11 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048559
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |