Trials / Completed
CompletedNCT03495973
Prospective Observational Study on Ustekinumab (Stelara) Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease
Prospective Observational Study on Stelara Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease (PROSE)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 114 (actual)
- Sponsor
- Janssen-Cilag Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-10-25
- Primary completion
- 2020-11-22
- Completion
- 2020-11-22
- First posted
- 2018-04-12
- Last updated
- 2025-02-03
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT03495973. Inclusion in this directory is not an endorsement.