Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

• Status: Completed
• Trial end date: 2015-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Biotech, Inc.
• Treatments: Antibodies, Monoclonal; Golimumab

Criteria

Inclusion Criteria:

• Complete medical coverage and pharmacy benefits

• Six months of continuous enrollment prior to the date of cohort entry

Exclusion Criteria:

• Participants will be excluded if they do not have information on age, gender or enrollment