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Therapeutic Effect of New Biologics in Crohn's Disease

NCT ID: NCT04923100

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-10

Study Completion Date

2025-03-29

Brief Summary

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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

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Conditions

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Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Treatment Side Effects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiayin Yao

Role: CONTACT

Phone: 13826462890

Email: [email protected]

Facility Contacts

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Jiayin Yao

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37554510 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34663208 (View on PubMed)

Other Identifiers

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2021ZSLYEC-066

Identifier Type: -

Identifier Source: org_study_id