Clinical Efficacy of Ustekinumab in Crohn's Disease

Kazakhstan Scientific Society for Study of intestine diseases150 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Crohn's Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

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

Outcomes

Primary Outcomes

The proportion of patients with a reduced level of disease activity by 30% or more according to the Crohn's Disease Activity Index

Time frame: at week 24 of therapy

Secondary Outcomes

Proportion of patients with a 30% or more reduction in disease activity according to the Crohn's Disease Activity Index

Time frame: at 12 and 52 weeks of therapy

Proportion of patients in endoscopic remission based on Simple Endoscopic Score for Crohn's Disease

Time frame: at 24 and 52 weeks

Dynamics of fecal calprotectin levels

Time frame: at 24 and 52 weeks

Proportion of patients with normalization of Magnetic resonance enterography based on the Magnetic Resonance Index of Activity

Time frame: at 12 and 52 weeks

Dynamics of quality of life assessment based on the Short Inflammatory Bowel Disease Questionnaire

Time frame: at 12, 24 and 52 weeks

Dynamics of antibody synthesis to the drug Ustekinumab

Time frame: at 0/1, 24 and 52 weeks

List of medications indicated in the general scheme with Odeston

Time frame: through study completion, an average of 1 year

Dynamics of assessing patient adherence to treatment using the Morisky-Green scale

Time frame: at 0/1, 12, 24 and 52 weeks

Collection of information on adverse reactions and/or registration of pregnancy cases

Central Contacts

Kanat Khazhidinov

CONTACT

+7 707 413 8263 kanat.khazhidinov@smo-mera.kz

Yekaterina Sakhabutdinova

CONTACT

+7 707 375 8530 yekaterina.sakhabutdinova@smo-mera.kz

Data from ClinicalTrials.gov

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