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Prospective Observational Study on Ustekinumab (Stelara) Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease

NCT03495973 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 114

Last updated 2025-02-03

No results posted yet for this study

Summary

The main purpose of this study is to assess ustekinumab's ability to induce clinical response and remission ("effectiveness") at Week 16 and remission at Week 52 and Week 104 in participants with Crohn's disease (CD). Response and remission will be assessed using clinical parameters. Retention rate at week 52 and 104 will also be studied.

Conditions

  • Crohn Disease

Interventions

DRUG

Ustekinumab

Participants that are initiated on treatment with ustekinumab and are registered in Swibreg will be recruited into the cohort. All aspects of treatment and clinical management of participants will be in accordance with local clinical practice and applicable local regulations, and at the discretion of the participating physician.

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Ltd. Clinical Trial · Janssen-Cilag Ltd.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2020-11-22
Completion
2020-11-22

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03495973 on ClinicalTrials.gov