Clinical Efficacy of Ustekinumab in Crohn's Disease

Kazakhstan Scientific Society for Study of intestine diseases

Status: Enrolling

Conditions: Crohn's Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06523647

KSSSID-01-23

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.