Status:
COMPLETED
Subject Insights to Understand Rheumatoid Arthritis (RA)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Brief Summary
Rheumatoid arthritis (RA) is a chronic, systemic autoimmune disease affecting the joints and can lead to joint pain, swelling, redness and stiffness and can cause deformity, loss of strength and immob...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 3 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 17 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03285191
Start Date
July 3 2017
End Date
August 17 2017
Last Update
August 15 2018
Active Locations (1)
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1
GSK Investigational Site
Bollington, Cheshire, United Kingdom, SK10 5JB