Clinical trial NCT03285191: Subject Insights to Understand Rheumatoid Arthritis (RA)
Official title: Patient Interviews to Better Understand Disease Experience and Unmet Treatment Needs in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Keywords: NRS
Concept elicitation
Real-time data capture
Rheumatoid arthritis
GSK3196165
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty English speaking subjects from the US with RA who are inadequate responders to csDMARDs and/or bDMARDs will be included in this study.

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 immobility. This cross-sectional qualitative study aims to explore the burden of established RA by conducting semi-structured Concept elicitation (CE) interviews (60 minutes duration) and real-time data capture task. The conceptual model developed from this data will be used to support the development of GSK3196165, a recombinant human monoclonal antibody (mAb) targeted for the treatment of RA. The CE interviews will explore the subject experience of RA and will collect information about symptoms, disease impact on functioning and health related quality of life (HRQoL), and treatment experiences/impacts of the condition and the language used by subjects to describe them. Following the CE interview, subjects will be asked to complete a brief symptom ranking exercise where they will need to rank how bothersome each RA symptom is and how important it would be to improve with treatment on a 1-5 numerical rating scale (NRS). After the interviews, the real-time disease experience of subjects will be captured by the real-time data capture app-based activity over a period of 7 days. Approximately 30 English-speaking subjects from the United States (US) with RA who are inadequate responders of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and/or (bDMARDs) will participate in the interviews and of these, 10 subjects will be offered the opportunity to participate in the real-time data capture sub study.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects with RA participating in CE interviews
timeFrame: 1 day
Secondary outcomes:
measure: Analysis of RA experience by using real-time data data capture task
timeFrame: Up to 7 days
measure: Preparation of the conceptual model
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Bollington
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: