Observational Study of Golimumab Intravenous Infusion

Overview

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

Full Title of Study: “Golimumab Intravenous Infusion Registry (GO-IV)”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2016

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Number of Participants With use of Pre-infusion Medications
    • Time Frame: Baseline up to end of study (2 years) or early withdrawal
    • 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.
  • Number of Participants With use of Concomitant Medications at Time of Infusion
    • Time Frame: Baseline up to end of study (2 years) or early withdrawal
    • 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.
  • Number of Participants With Infusion Reaction Treatments
    • Time Frame: Baseline up to end of study (2 years) or early withdrawal
    • 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.
  • Number of Participants With Subsequent Reactions After the First Infusion Reaction
    • Time Frame: Baseline up to end of study (2 years) or early withdrawal
    • 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.
  • Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score
    • Time Frame: Baseline up to end of study (2 years) or early withdrawal
    • 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).
  • Percentage of Participants With Absolute Change of at Least 3 Points in RAID Score
    • Time Frame: Baseline up to end of study (2 years) or early withdrawal
    • 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).
  • Percentage of Participants With Relative Change of at Least 50 Percent (%) and a Maximum Score of 2 in RAID Score
    • Time Frame: Baseline up to end of study (2 years) or early withdrawal
    • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Janssen Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janssen Inc. Clinical Trial, Study Director, Janssen Inc.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.