Clinical Efficacy of Ustekinumab in Crohn's Disease

NCT06523647 | Recruiting

• 1 other identifier: KSSSID-01-23
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• 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

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

  at 12, 24 and 52 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Kazakhstan Scientific Society for Study of intestine diseases: lead

Study Sites (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, 055990, 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

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study 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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 26, 2024
• Study Start: June 27, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

KA (4)