Clinical trial NCT02390700: Observational Study of Golimumab Intravenous Infusion
Official title: Golimumab Intravenous Infusion Registry (GO-IV)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Observational
Golimumab
SIMPONI
Intravenous Infusion
Lead sponsor: Janssen Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Infusion Reactions
timeFrame: Up to end of study (2 years) or early withdrawal
Secondary outcomes:
measure: Number of Participants With use of Pre-infusion Medications
timeFrame: Baseline up to end of study (2 years) or early withdrawal
measure: Number of Participants With use of Concomitant Medications at Time of Infusion
timeFrame: Baseline up to end of study (2 years) or early withdrawal
measure: Number of Participants With Infusion Reaction Treatments
timeFrame: Baseline up to end of study (2 years) or early withdrawal
measure: Number of Participants With Subsequent Reactions After the First Infusion Reaction
timeFrame: Baseline up to end of study (2 years) or early withdrawal
measure: Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score
timeFrame: Baseline up to end of study (2 years) or early withdrawal
measure: Percentage of Participants With Absolute Change of at Least 3 Points in RAID Score
timeFrame: Baseline up to end of study (2 years) or early withdrawal
measure: Percentage of Participants With Relative Change of at Least 50 Percent (%) and a Maximum Score of 2 in RAID Score
timeFrame: Baseline up to end of study (2 years) or early withdrawal
Other outcomes:
Locations:
city: Saint-John'S
country: Canada
state: Newfoundland and Labrador
city: Ancaster
country: Canada
state: Ontario
city: Barrie
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Nepean
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: St.Catharines
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Victoria
country: Canada
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References: