Clinical Efficacy of Ustekinumab in Crohn's Disease

Recruiting

• Conditions: Crohn's Disease

• Registration Number: NCT06523647
• Lead Sponsor: Kazakhstan Scientific Society for Study of intestine diseases

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-27
• Status Verified: 2024-07
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with a reduced level of disease activity by 30% or more according to the Crohn's Disease Activity Index	at week 24 of therapy

Secondary Outcome Measures

Name	Time	Method
Dynamics of erythrocyte sedimentation rate parameters	at 24 and 52 weeks
Dynamics of C-reactive protein parameters	at 24 and 52 weeks
Proportion of patients with a 30% or more reduction in disease activity according to the Crohn's Disease Activity Index	at 12 and 52 weeks of therapy
Collection of information on adverse reactions and/or registration of pregnancy cases	through study completion, an average of 1 year
Dynamics of quality of life assessment based on the Short Inflammatory Bowel Disease Questionnaire	at 12, 24 and 52 weeks
Dynamics of antibody synthesis to the drug Ustekinumab	at 0/1, 24 and 52 weeks
List of medications indicated in the general scheme with Odeston	through study completion, an average of 1 year
Dynamics of albumin parameters	at 24 and 52 weeks
Dynamics of serum iron parameters	at 24 and 52 weeks
Proportion of patients in endoscopic remission based on Simple Endoscopic Score for Crohn's Disease	at 24 and 52 weeks
Dynamics of fecal calprotectin levels	at 24 and 52 weeks
Proportion of patients with normalization of Magnetic resonance enterography based on the Magnetic Resonance Index of Activity	at 12 and 52 weeks
Dynamics of red blood cell parameters	at 24 and 52 weeks
Dynamics of potassium parameters	at 24 and 52 weeks
Dynamics of vitamin B9 parameters	at 24 and 52 weeks
Dynamics of serum iron-binding capacity parameters	at 24 and 52 weeks
Dynamics of assessing patient adherence to treatment using the Morisky-Green scale	at 0/1, 12, 24 and 52 weeks
Dynamics of platelet parameters	at 24 and 52 weeks
Dynamics of total protein parameters	at 24 and 52 weeks
Dynamics of Nutritional Risk Index indicators	at 24 and 52 weeks
Dynamics of hemoglobin parameters	at 24 and 52 weeks
Dynamics of leukocyte parameters with leukocyte formula	at 24 and 52 weeks
Dynamics of sodium parameters	at 24 and 52 weeks

Trial Locations

Locations (4)

Non-Profit Joint Stock Company "Kazakh National Medical University named after S.D. Asfendiyarov"; 🇰🇿 Almaty, Kazakhstan

NJSC "West Kazakhstan Marat Ospanov Medical University"; 🇰🇿 Aktobe, Kazakhstan

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

State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Health Department of the Turkestan Region; 🇰🇿 Shymkent, Kazakhstan