Therapeutic Effect of New Biologics in Crohn's Disease

Ulcerative Colitis Clinical Trial

Official title:

Therapeutic Effect of New Biologics in Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923100
• Other study ID #: 2021ZSLYEC-066
• Status: Recruiting
• Start date: June 10, 2021
• Est. completion date: March 29, 2025

Study information

• Verified date: October 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Jiayin Yao
• Phone: 13826462890
• Email: yjyin3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

New types of biologics have brought advantages in therapy strategies for Crohn's disease. However, clinical data evaluating their efficacy and adverse in China is lacking. We aimed to evaluate the short-term and long-term therapeutic effect as well as drug adverse of Ustekinumab (UST) and Vedolizumab (VED). Besides, we aim to figure out the independent factors predicting the effectiveness of new biologics. Relations between drug exposure (trough concentration and antibody concentration) and therapeutic efficacy are study in-depth by this retrospective observational study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 29, 2025
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 80 Years

Eligibility

Inclusion Criteria:

• Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics.

Exclusion Criteria:

• loss of follow-up, incomplete clinical data, without confirmed diagnosis

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Treatment Side Effects
• Ulcerative Colitis

Locations

Country	Name	City	State
China	the Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endoscopic remission	Endoscopic remission referred to those with simple endoscopic score for Crohn's disease (SES-CD)=2	short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
Secondary	clinical remission	Clinical remission was defined as Crohn's disease activity index (CDAI) below 150	short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
Secondary	clinical response	endoscopic response referred to those with a reduction of SES-CD > 50% baseline	short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
Secondary	endoscopic response	endoscopic response referred to those with a reduction of SES-CD > 50% baseline	short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)