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NCT02852850 Clinical Trial

In Vivo Molecular Imaging Predicts Therapeutic Response in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:
In Vivo Molecular Imaging With Infliximab Antibody With FITC Predicts Therapeutic Response in Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02852850
Other study ID # 2016SDU-QILU-12
Secondary ID
Status Recruiting
Phase N/A
First received July 29, 2016
Last updated October 13, 2016
Start date January 2016

Study information
Verified date October 2016
Source Shandong University
Contact Yanqing Li, PhD. MD.
Phone 86-531-82169236
Email liyanqing@sdu.edu.cn
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Observational

Clinical Trial Summary

Molecular imaging with infliximab antibody with FITC has the potential to predict therapeutic responses to infliximab antibody and can be used for personalized medicine in ulcerative colitis.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with active ulcerative colitis will receive infliximab antibody therapy.

Exclusion Criteria:

- Patients with impaired blood clotting.

- Patients with short bowel syndrome.

- Patients during the pregnancy and lactation period.

- Patients received enema therapy within 1 month before inclusion in the study, or had anti-TNF therapy within the last 12 months.

- Patients participated in another clinical trial or administrated other investigational drugs within 4 months prior to the screening visit.

- Patients with moderate to severe heart failure, active tuberculosis or acute infections.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of specific fluorescence signal of mTNF+ cells in patients with UC 30 months No
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