Therapeutic Effect of New Biologics in Crohn's Disease

NCT04923100 | Completed

• 1 other identifier: 2021ZSLYEC-066
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• clinical remission

  short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)

• clinical response

  short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)

• endoscopic response

  short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 501655, China

Location

Related Publications (2)

• Yao J, Peng X, Zhong Y, Su T, Bihi A, Zhao J, Liu T, Wang W, Hu P, Zhang M, Zhi M. Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn's disease. Front Med (Lausanne). 2023 Jul 24;10:1105981. doi: 10.3389/fmed.2023.1105981. eCollection 2023.

  PMID: 37554510 DERIVED

• Yao JY, Zhang M, Wang W, Peng X, Zhao JZ, Liu T, Li ZW, Sun HT, Hu P, Zhi M. Ustekinumab trough concentration affects clinical and endoscopic outcomes in patients with refractory Crohn's disease: a Chinese real-world study. BMC Gastroenterol. 2021 Oct 18;21(1):380. doi: 10.1186/s12876-021-01946-8.

  PMID: 34663208 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

intestinal mucosa biopsy

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: June 10, 2021
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CN (1)