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Golimumab Safety and Surveillance Program Using the Ingenix NHI Database
The participants 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 rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients treated with golimumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic non-biological treatments.
Details
| Lead sponsor | Janssen Biotech, Inc. |
|---|---|
| Status | COMPLETED |
| Enrolment | 1064 |
| Start date | Tue Apr 14 2009 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sun May 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Rheumatoid Arthritis
- Arthritis, Psoriatic
- Ankylosing Spondylitis
Interventions
- systemic non-biological treatments
- anti-TNF biologics
- golimumab
- non-anti-TNF biologics
- general population