Status:
RECRUITING
Clinical Efficacy of Ustekinumab in Crohn's Disease
Lead Sponsor:
Kazakhstan Scientific Society for Study of intestine diseases
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Brief Summary
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06523647
Start Date
June 27 2023
End Date
December 1 2025
Last Update
July 26 2024
Active Locations (4)
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1
NJSC "West Kazakhstan Marat Ospanov Medical University"
Aktobe, Kazakhstan
2
Non-Profit Joint Stock Company "Kazakh National Medical University named after S.D. Asfendiyarov"
Almaty, Kazakhstan, 055990
3
State-owned public enterprise with the right of economic management "Multidisciplinary City Hospital No. 1" of the Akimat of Astana
Astana, Kazakhstan
4
State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Health Department of the Turkestan Region
Shymkent, Kazakhstan