Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Arthritis, Psoriatic; Ankylosing Spondylitis; Rheumatoid Arthritis

Treatments: Biological: non-anti-TNF biologics; Biological: anti-TNF biologics; Drug: systemic non-biological treatments; Biological: golimumab; Other: general population

Study type: Observational

Funder types: Industry

Identifiers

NCT01081717

CNTO148ART4002 (Other Identifier)

CR016720

Details and patient eligibility

About

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.

Full description

The participants included in this study will be drawn from the Ingenix Normative Health Informatics Database, a proprietary research database containing claims and enrollment data dating back to 1993 for members of a large, geographically diverse US health plan. This study will include cohorts of participants who have claims consistent with a diagnosis of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis and who initiate golimumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological treatments. Participants will be identified by claims bearing codes for dispensed drugs, procedures or diagnoses and followed after the launch of golimumab for up to 8 years. A sample of enrolled health plan members without claims evidence of diagnosis or treatment of Rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis will also be selected. The claims database will be used to estimate the incidence of the primary outcomes of serious infections, tuberculosis (TB) and non-TB mycobacterial infections, malignancies such as lymphoma, and other selected outcomes. No study agents will be administered in this study. All participants will receive standard-of-care treatment as prescribed by their physician

Enrollment: 1,064 patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,064 participants in 5 patient groups

001

Description:

golimumab as prescribed

Treatment:

Biological: golimumab

002

Description:

anti-TNF biologics as prescribed

Treatment:

Biological: anti-TNF biologics

003

Description:

non-anti-TNF biologics as prescribed

Treatment:

Biological: non-anti-TNF biologics

004

Description:

systemic non-biological treatments as prescribed

Treatment:

Drug: systemic non-biological treatments

005

Description:

general population non-treated cohort

Treatment:

Other: general population