Therapeutic Effect of New Biologics in Crohn's Disease

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Treatment Side Effects Ulcerative Colitis

Age range

17 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 501655, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

endoscopic remission

Time frame: 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 outcomes

clinical remission

Time frame: 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

Time frame: 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
endoscopic response

Time frame: 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

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2025
First posted: Jun 11, 2021
Registry last updated: Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed