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Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database
The patients included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan. The objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in psoriasis patients treated with ustekinumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic non-biological treatments.
Details
| Lead sponsor | Janssen Biotech, Inc. |
|---|---|
| Status | COMPLETED |
| Enrolment | 2040 |
| Start date | Tue Feb 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Sep 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Psoriasis
Interventions
- anti-TNF biologics
- general population
- non-anti-TNF biologics
- ustekinumab
- systemic non-biological treatments