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

NCT ID: NCT03495973

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2020-11-22

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ustekinumab

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant has a diagnosis of CD confirmed by investigator
• Participants with active CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic therapy or have medical contraindications to such therapies
• The participant must sign informed consent before enrollment in the study. The consent form permits extraction of data from SWIBREG at baseline and during participation of the study and linkages to the Patient Registry (Patientregistret), SCB's registry USA for occupational details (Longitudinell integrationsdatabas for sjukforsakrings- och arbetsmarknadsstudi er), the Social Insurance registry on long-term sick leave (Forsakringskassans register gallande sjukskrivningar) and the Prescription registry (Lakemedelsregistret)
• The participant must have been initiated on treatment with ustekinumab within the last 2 weeks (that is including those who already discontinued) or started on ustekinumab treatment less than (<) 3 months ago if treatment start was documented in SWIBREG within 2 weeks of onset and has a record of Harvey Bradshaw Index (HBI) when starting ustekinumab

Exclusion Criteria

• The participant is enrolled in a clinical trial (randomized or non-randomized) in which the treatment of CD is dictated by a study protocol. If the participant is participating in another observational study (non-interventional), the participant may be included in this observational study
• Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the start of the study or the first data collection time point
• Participants who started ustekinumab despite contraindications for use
• Participants with planned stop of treatment with ustekinumab within 24 months from onset of treatment, that is bridging to other treatment or pregnancy planned

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Ltd.

Locations

Universitetssjukhuset Orebro

Örebro, , Sweden

Countries

Sweden

Other Identifiers

CNTO1275CRD4006

Identifier Type: OTHER

Identifier Source: secondary_id

CR108430

Identifier Type: -

Identifier Source: org_study_id