Observational Study of Golimumab Intravenous Infusion

Rheumatoid Arthritis Clinical Trial

— GO-IV  

Official title:

Golimumab Intravenous Infusion Registry (GO-IV)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02390700
• Other study ID #: CR105631
• Secondary ID: CNTO148ARA4003
• Status: Terminated
• Phase: Phase 4
• First received: March 11, 2015
• Last updated: November 16, 2016
• Start date: February 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Janssen Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Infusion Reactions	The count of infusion reactions will be reported.	Up to end of study (2 years) or early withdrawal	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No