Observational Study of Golimumab Intravenous Infusion (GO-IV)

Janssen (J&J Innovative Medicine)

Status: Terminated

Conditions: Rheumatoid Arthritis

Treatments: Biological: Golimumab Intravenous

Study type: Observational

Funder types: Industry

Identifiers

NCT02390700

CR105631

CNTO148ARA4003 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the incidence and management of infusion reactions with Golimumab intravenous infusion.

Full description

This is a prospective, observational, non-interventional (no treatment given during course of the study) multi-center (when more than one hospital or medical school team work on a medical research study), study that will enroll participants with rheumatoid arthritis (RA) in Canada. Only data available from source documentation will be collected. The participation in this study will not impact on the standard of care of the participant or any benefits to which they are otherwise entitled. All aspects of treatment decisions and clinical management of participants will be in accordance with clinical practice and at the discretion of the health care provider. Participants' safety will be monitored throughout the study.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have a confirmed diagnosis of rheumatoid arthritis
• Participants must have provided a written consent for data collection by signing an informed consent form indicating that he/she understand the purpose and procedures for data collection and are willing to participate in the study
• Participants are golimumab-naive (never have used golimumab both SC and IV formulations)
• Participants are prescribed golimumab intravenous by an appropriate physician as per the Canadian Product Monograph

Exclusion criteria

• Participant who has been treated with golimumab in the past
• Participant has been diagnosed with psoriatic arthritis or ankylosing spondylitis
• Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or first data collection time point
• Participant is currently enrolled in an interventional study

Trial design

78 participants in 1 patient group

Golimumab Intravenous

Description:

Participants with rheumatoid arthritis (RA) in Canada, will be observed for 24 months. Only data available from source documentation will be collected.

Treatment:

Biological: Golimumab Intravenous