Observational Study of Golimumab Intravenous Infusion (GO-IV)

Golimumab Intravenous Infusion Registry (GO-IV)

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

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: Golimumab Intravenous

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Canada
  • Victoria, Canada
  • Newfoundland and Labrador
    • Saint-John'S, Newfoundland and Labrador, Canada
  • Ontario
    • Ancaster, Ontario, Canada
    • Barrie, Ontario, Canada
    • Kitchener, Ontario, Canada
    • Mississauga, Ontario, Canada
    • Nepean, Ontario, Canada
    • Oakville, Ontario, Canada
    • St.Catharines, Ontario, Canada
    • Toronto, Ontario, Canada
  • Quebec
    • Laval, Quebec, Canada
    • Montreal, Quebec, Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Canadian participants with rheumatoid arthritis (RA), who have been prescribed intravenous golimumab prior to, and independently of, study enrollment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Golimumab Intravenous; Participants with rheumatoid arthritis (RA) in Canada, will be observed for 24 months. Only data available from source documentation will be collected.	Biological: Golimumab Intravenous; This is a non-interventional study. Participants with rheumatoid arthritis in Canada will be observed for 24 months.; Other Names: SIMPONI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Infusion Reactions	The count of infusion reactions will be reported.	Up to end of study (2 years) or early withdrawal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline up to end of study (2 years) or early withdrawal
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score	The RAID is self-administered questionnaire which includes seven domains (pain, function, fatigue, physical and psychological wellbeing, sleep disturbance and coping). Each domain is evaluated using a single question answered by a 0 to 10 numerical rating scale. Each domain also has a specific weight assigned by a patient survey. The RAID score is a continuous variable ranging from 0 (best) to 10 (worst).	Baseline up to end of study (2 years) or early withdrawal
Percentage of Participants With Absolute Change of at Least 3 Points in RAID Score	The RAID is self-administered questionnaire which includes seven domains (pain, function, fatigue, physical and psychological wellbeing, sleep disturbance and coping). Each domain is evaluated using a single question answered by a 0 to 10 numerical rating scale. Each domain also has a specific weight assigned by a patient survey. The RAID score is a continuous variable ranging from 0 (best) to 10 (worst).	Baseline up to end of study (2 years) or early withdrawal
Percentage of Participants With Relative Change of at Least 50 Percent (%) and a Maximum Score of 2 in RAID Score	The RAID is self-administered questionnaire which includes seven domains (pain, function, fatigue, physical and psychological wellbeing, sleep disturbance and coping). Each domain is evaluated using a single question answered by a 0 to 10 numerical rating scale. Each domain also has a specific weight assigned by a patient survey. The RAID score is a continuous variable ranging from 0 (best) to 10 (worst).	Baseline up to end of study (2 years) or early withdrawal

Collaborators and Investigators

• Sponsor: Janssen Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Estimate): November 17, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Golimumab; Observational; Intravenous Infusion; SIMPONI
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; Golimumab
• Other Study ID Numbers: CR105631; CNTO148ARA4003 (Other Identifier: Janssen Inc.)