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NCT03285191

Subject Insights to Understand Rheumatoid Arthritis (RA)

Completed Last updated 15 August 2018
What this trial tests

trial testing Numerical rating scale in Arthritis, Rheumatoid in 30 participants. Completed in 17 August 2017.

Timeline
3 July 2017
Primary endpoint
17 August 2017
17 August 2017

Quick facts

Lead sponsorGlaxoSmithKline
StatusCompleted
Study typeOBSERVATIONAL
Enrollment30
Start date3 July 2017
Primary completion17 August 2017
Estimated completion17 August 2017
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Molecular and Cellular Heterogeneity in Rheumatoid Arthritis: Mechanisms and Clinical Implications.
    Zhao J, Guo S, Schrodi SJ, He D. · · 2021 · cited 105× · PMID 34899757 · DOI 10.3389/fimmu.2021.790122

Verify or expand the search:

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Other GlaxoSmithKline trials

Trials by the same sponsor.

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Data sources for this page

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