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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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12 December 2020 |
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Main ID: |
NCT03285191 |
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Date of registration:
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29/06/2017 |
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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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Subject Insights to Understand Rheumatoid Arthritis (RA)
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Scientific title:
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Patient Interviews to Better Understand Disease Experience and Unmet Treatment Needs in Rheumatoid Arthritis |
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Date of first enrolment:
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July 3, 2017 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03285191 |
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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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United Kingdom
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female, aged >=18 years or over.
- Subject has a diagnosis of rheumatoid arthritis and has had this diagnosis for at
least 6 months.
- Subject has a minimum of four swollen and tender joints.
- Subject is either an inadequate responder to csDMARDs and has never received a bDMARD
or an inadequate responder to bDMARDs (subject may be receiving bDMARDs only or may be
continuing csDMARD treatment in addition to receiving a bDMARD).
- Subject is willing and able to participate in the study and provide written informed
consent.
- Subject is a fluent US-English speaker and is able to read, write and fully understand
the US-English language.
- Subject is willing and able to participate in a 60-minute interview and optional app
task to discuss their experience of rheumatoid arthritis.
For subjects taking part in real-time data capture:
- Subject owns/or has access to either a smartphone [iPhone Operating System (iOS) or
android] or tablet which has video, audio/microphone and photographic capabilities and
access to either the Apple app store or Google play store to download the app.
- Subject is willing and able to take part in the real time data application task and
respond to a series of questions/tasks fielded via the application over the course of
seven days and is willing to respond to some brief questions following the real-time
data capture task about their experience of using the app and completing the tasks, in
a 5-10 minute telephone call.
- Subject would feel comfortable recording short videos of themselves and providing
audio commentary in response to app questions/tasks.
Exclusion Criteria:
- Subject has a history of other inflammatory rheumatological or autoimmune disorders
that are not secondary to RA.
- Subject has significant unstable or uncontrolled acute or chronic disease other than
RA.
- Subject is unwilling or unable to comply with the requirements of the study or has a
physical or mental condition that, in the opinion of the physician, may affect the
subject's ability to participate in the study, the responses he/she might provide or
their ability to provide consent.
- Subject is currently or has previously been enrolled in a clinical trial for RA in the
past year.
Age minimum:
18 Years
Age maximum:
N/A
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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Other: Real-time data capture app
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Other: Numerical rating scale
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Primary Outcome(s)
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Number of subjects with RA participating in CE interviews
[Time Frame: 1 day]
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Secondary Outcome(s)
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Preparation of the conceptual model
[Time Frame: Up to 7 days]
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Analysis of RA experience by using real-time data data capture task
[Time Frame: Up to 7 days]
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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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