Therapeutic Effect of New Biologics in Crohn's Disease

Recruiting

• Conditions: Crohn Disease; Inflammatory Bowel Diseases; Ulcerative Colitis; Treatment Side Effects

• Registration Number: NCT04923100
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-07
• Study Start: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-03-29
• Study Completion: 2025-03-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
endoscopic remission	short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)	Endoscopic remission referred to those with simple endoscopic score for Crohn's disease (SES-CD)≤2

Secondary Outcome Measures

Name	Time	Method
endoscopic response	short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)	endoscopic response referred to those with a reduction of SES-CD \> 50% baseline
clinical remission	short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)	Clinical remission was defined as Crohn's disease activity index (CDAI) below 150
clinical response	short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)	endoscopic response referred to those with a reduction of SES-CD \> 50% baseline

Trial Locations

Locations (1)

the Sixth Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China