Observational Study of Golimumab Intravenous Infusion

Janssen Inc.78 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

Golimumab IntravenousBIOLOGICAL

This is a non-interventional study. Participants with rheumatoid arthritis in Canada will be observed for 24 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Unnamed facility

St. John's, Newfoundland and Labrador, Canada

Unnamed facility

Ancaster, Ontario, Canada

Unnamed facility

Barrie, Ontario, Canada

Unnamed facility

Kitchener, Ontario, Canada

Outcomes

Primary Outcomes

Number of Participants With Infusion Reactions

The count of infusion reactions will be reported.

Time frame: Up to end of study (2 years) or early withdrawal

Secondary Outcomes

Number of Participants With use of Pre-infusion Medications

Participants with administration of Pre-infusion medications or combination of Pre-infusion medications will be reported. The list of pre-treatments includes: acetaminophen, anti-histamines, steroids (Hydrocortisone, Prednisone), acetaminophen alone, anti-histamines alone, steroids alone, steroids + anti-histamines, steroids + acetaminophen, anti-histamines + acetaminophen, steroids + anti-histamines + acetaminophen.

Time frame: Baseline up to end of study (2 years) or early withdrawal

Number of Participants With use of Concomitant Medications at Time of Infusion

Participants with type of concomitant medications used at time of infusion will be reported. The groups of concomitant medication of interest are: any immunosuppressant (IS), methotrexate and corticosteroids.

Time frame: Baseline up to end of study (2 years) or early withdrawal

Number of Participants With Infusion Reaction Treatments

For each infusion administration with infusion reactions, type of medications was used to treat the reaction will be reported. The list of medications includes anti-histamines, steroids, and epinephrine.

Time frame: Baseline up to end of study (2 years) or early withdrawal

Number of Participants With Subsequent Reactions After the First Infusion Reaction

For each participant who has experienced at least 1 infusion reaction after enrolment, occurrence of infusion reaction at subsequent infusions after the first infusion reaction will be assessed.

Time frame: Baseline up to end of study (2 years) or early withdrawal

Data from ClinicalTrials.gov

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