Evaluating Ustekinumab for treating Crohn's Disease
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components
This study is testing how well Ustekinumab works for people with Crohn's Disease by looking at their treatment results and responses to the medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kazakhstan Scientific Society for Study of intestine diseases Academic / other |
| Drugs / interventions | Ustekinumab |
| Locations | 4 sites (Aktobe and 3 other locations) |
| Trial ID | NCT06523647 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the clinical efficacy of Ustekinumab in patients diagnosed with Crohn's Disease. It includes both retrospective and prospective components, focusing on individuals who were first prescribed the medication within a specific timeframe. The study aims to gather data on treatment outcomes and patient responses to Ustekinumab, contributing to a better understanding of its effectiveness in managing this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been prescribed Ustekinumab between January 1 and December 31, 2024.
Not a fit: Patients with contraindications to Ustekinumab, such as active infections or other significant health issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Ustekinumab, potentially improving treatment strategies for Crohn's Disease.
How similar studies have performed: While this study focuses on Ustekinumab, similar observational studies have shown promise in evaluating the efficacy of biologic treatments for Crohn's Disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aktobe and 3 other locations
- NJSC "West Kazakhstan Marat Ospanov Medical University" — Aktobe, Kazakhstan (Recruiting)
- Non-Profit Joint Stock Company "Kazakh National Medical University named after S.D. Asfendiyarov" — Almaty, Kazakhstan (Recruiting)
- State-owned public enterprise with the right of economic management "Multidisciplinary City Hospital No. 1" of the Akimat of Astana — Astana, Kazakhstan (Recruiting)
- State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Health Department of the Turkestan Region — Shymkent, Kazakhstan (Recruiting)
Study contacts
- Study coordinator: Kanat Khazhidinov
- Email: kanat.khazhidinov@smo-mera.kz
- Phone: +7 707 413 8263
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.