Clinical Efficacy of Ustekinumab in Crohn's Disease

July 23, 2024 updated by: Kazakhstan Scientific Society for Study of intestine diseases

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

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Kazakhstan
      • Aktobe, Kazakhstan
        • Recruiting
        • NJSC "West Kazakhstan Marat Ospanov Medical University"
        • Contact:
          • Aset Kaliev
          • Phone Number: +7 (7132) 563425
          • Email: info@.zkmu.kz
      • Almaty, Kazakhstan, 055990
        • Recruiting
        • Non-Profit Joint Stock Company "Kazakh National Medical University named after S.D. Asfendiyarov"
        • Contact:
      • Astana, Kazakhstan
        • Recruiting
        • State-owned public enterprise with the right of economic management "Multidisciplinary City Hospital No. 1" of the Akimat of Astana
        • Contact:
      • Shymkent, Kazakhstan
        • Recruiting
        • State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Health Department of the Turkestan Region
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include male and female patients aged 18 years and older, with a confirmed diagnosis of Crohn's disease, on therapy with the drug Ustekinumab

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at week 24 of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
at 24 and 52 weeks
Dynamics of fecal calprotectin levels
Time Frame: at 24 and 52 weeks
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
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
at 12, 24 and 52 weeks
Dynamics of antibody synthesis to the drug Ustekinumab
Time Frame: at 0/1, 24 and 52 weeks
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
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
at 0/1, 12, 24 and 52 weeks
Collection of information on adverse reactions and/or registration of pregnancy cases
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Dynamics of red blood cell parameters
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of hemoglobin parameters
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of platelet parameters
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of leukocyte parameters with leukocyte formula
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of erythrocyte sedimentation rate parameters
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of potassium parameters
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of sodium parameters
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of C-reactive protein parameters
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of albumin parameters
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of total protein parameters
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of serum iron parameters
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of serum iron-binding capacity parameters
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of vitamin B9 parameters
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks
Dynamics of Nutritional Risk Index indicators
Time Frame: at 24 and 52 weeks
at 24 and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kazakhstan Scientific Society for Study of intestine diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSSSID-01-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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