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

Sponsor
Janssen-Cilag Ltd.
Study ID
NCT03495973
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 25, 2017
Status verified
Jan 2025
Primary completion
Nov 22, 2020
Completion
Nov 22, 2020

Study Design

Enrollment
114 participants (actual)

Arms

  • Arm: Participants with Crohn's Disease (CD)
    Participants with CD will be assessed for the effectiveness of ustekinumab in accordance with national guidelines and routine standard of care. Data will be prospectively collected with the aid of the Swedish inflammatory bowel disease (IBD) registry, SWIBREG and medical records of each participant. Data will also be collected retrospectively from SWIBREG and other databases including national databases such as the participant registry in which cases the national databases will be considered source data.

Primary Outcome Measure

Percentage of Participants with Clinical Response at Week 16, Based on Harvey Bradshaw Index (HBI) [ Time Frame: Week 16 ]

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