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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 August 2023 |
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Main ID: |
NCT03729349 |
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Date of registration:
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01/11/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Golimumab for Adherence in Rheumatoid Arthritis
GO FAR |
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Scientific title:
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Golimumab for Adherence in Rheumatoid Arthritis |
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Date of first enrolment:
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January 15, 2019 |
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Target sample size:
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222 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03729349 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Janssen Inc. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Must have a confirmed diagnosis of rheumatoid arthritis
- About to initiate therapy with golimumab
- Must sign a participation agreement/informed consent form (ICF) allowing data
collection and source data verification in accordance with local requirements
Exclusion Criteria:
- Diagnosis of Axial Spondyloarthritis, Ankylosing Spondylitis or Psoriatic Arthritis
- Received an investigational drug (including investigational vaccines) or used an
invasive investigational medical device within 90 days before the start of the study
or the first data collection time point
- Currently enrolled in an investigational study
- Currently enrolled in an observational study sponsored or managed by a Janssen company
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Arthritis, Rheumatoid
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Intervention(s)
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Biological: Golimumab
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Primary Outcome(s)
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Impact of Adherence on Flares as Assessed by RA-FQ Score at 12 Month
[Time Frame: 12 Month]
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Impact of Adherence on Flares as Assessed by Rheumatoid Arthritis Flare Questionnaire (RA-FQ) Score at 6 Month
[Time Frame: 6 Month]
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Secondary Outcome(s)
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Number of Participants with Corticosteroid Use
[Time Frame: Months 6 and 12]
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Number of Participants with any Adverse Events (AEs), Serious Adverse Events (SAEs) or Discontinuation of Golimumab
[Time Frame: Months 6 and 12]
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Percentage of Adherent Participants at 6 and 12 Months
[Time Frame: Months 6 and 12]
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Predicting Factors for Adherence
[Time Frame: Months 6 and 12]
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Percentage of Participants with Response to Patient Support Program Question
[Time Frame: Months 6 and 12]
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Secondary ID(s)
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CNTO148ARA4010
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CR108555
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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