Observational Study of Golimumab Intravenous Infusion

• Register: ClinicalTrials.gov
• Last refreshed on: 28 November 2016
• Main ID: NCT02390700
• Date of registration: 11/03/2015
• Prospective Registration: No
• Primary sponsor: Janssen Inc.
• Public title: Observational Study of Golimumab Intravenous Infusion GO-IV
• Scientific title: Golimumab Intravenous Infusion Registry (GO-IV)
• Date of first enrolment: February 2015
• Target sample size: 78
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02390700
• Study type: Observational [Patient Registry]
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

Canada

Contacts

• Name: Janssen Inc. Clinical Trial
• Affiliation: Janssen Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Golimumab Intravenous

Primary Outcome(s)

Number of Participants With Infusion Reactions [Time Frame: Up to end of study (2 years) or early withdrawal]

Secondary Outcome(s)

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]

Number of Participants With use of Pre-infusion Medications [Time Frame: Baseline up to end of study (2 years) or early withdrawal]

Number of Participants With Subsequent Reactions After the First Infusion Reaction [Time Frame: Baseline up to end of study (2 years) or early withdrawal]

Number of Participants With Infusion Reaction Treatments [Time Frame: 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 [Time Frame: Baseline up to end of study (2 years) or early withdrawal]

Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score [Time Frame: 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 [Time Frame: Baseline up to end of study (2 years) or early withdrawal]

Secondary ID(s)

CR105631

CNTO148ARA4003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors