Clinical Efficacy of Ustekinumab in Crohn's Disease

NCT ID: NCT06523647

Last Updated: 2024-07-26

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

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-27

Study Completion Date

2025-12-31

Brief Summary

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Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.

Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 years and older;
* Patients who were first prescribed Ustekinumab between January 1 and December 31, 2024
* Patients who provided written informed consent to participate in the study

Exclusion Criteria

* Contraindications to the use of the drug Ustekinumab per the current instructions:

* Clinically significant active infection (active tuberculosis, active viral hepatitis);
* Pregnancy and lactation;
* A history of clinically significant, in the opinion of the investigator, psychiatric disorders that may interfere with the study procedures and compliance with the drug regimen;
* Ulcerative colitis;
* Malignant gastrointestinal diseases in history or at the time of inclusion in the study;
* Decompensated chronic diseases of the liver, kidneys, cardiovascular system, systemic vasculitis, diabetes mellitus;
* Abuse of alcohol or psychoactive drugs within 1 year before the start of this study (as reported by the patient);
* Participation in an interventional clinical trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kazakhstan Scientific Society for Study of intestine diseases

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NJSC "West Kazakhstan Marat Ospanov Medical University"

Aktobe, , Kazakhstan

Site Status RECRUITING

Non-Profit Joint Stock Company "Kazakh National Medical University named after S.D. Asfendiyarov"

Almaty, , Kazakhstan

Site Status RECRUITING

State-owned public enterprise with the right of economic management "Multidisciplinary City Hospital No. 1" of the Akimat of Astana

Astana, , Kazakhstan

Site Status RECRUITING

State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Health Department of the Turkestan Region

Shymkent, , Kazakhstan

Site Status RECRUITING

Countries

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Kazakhstan

Central Contacts

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Kanat Khazhidinov

Role: CONTACT

+7 707 413 8263

Yekaterina Sakhabutdinova

Role: CONTACT

+7 707 375 8530

Facility Contacts

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Aset Kaliev

Role: primary

+7 (7132) 563425

Marat Shoranov

Role: primary

+7(727)338-70-90

Marat Abduov

Role: primary

+7(7172) 27 20 28

Zhanbolat Dildabekov

Role: primary

+7 (7252) 53 78 99

Other Identifiers

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KSSSID-01-23

Identifier Type: -

Identifier Source: org_study_id

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